CCTV Interview with Zhu Guangyao: G20 will play a key role in stabilizing monetary policy.

  CCTV News:Innovation is a very important topic in this G20 Summit. The international community expects the Hangzhou Summit to contribute to the sustainable and inclusive growth of the world economy. So how should the G20 join hands to meet the challenges of the global economy? CCTV interviewed Zhu Guangyao, Vice Minister of Finance.

  The uncertainty of the current international economic situation has increased.

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  CCTV reporter Zhang Yu:One of the main purposes of the G20 Hangzhou Summit is to lead the healthy development of the international economy and strengthen the governance of international finance. What is the current international financial form? What’s the next step?

  Vice Minister of Finance Zhu Guangyao:In the current international economic situation, we analyze it this way. Since the outbreak of the global financial crisis in September 2008, the whole world, especially the G20, has been committed to restoring global economic growth. Eight years have passed, and the G20 has held ten summits, all of which are expected to make the world economy embark on a strong, sustainable and balanced growth channel. We objectively evaluate that the world economy is in the process of recovery for eight years, but this recovery is very slow and unbalanced. And some new uncertainties are increasing.

  G20 has achieved results in global economic governance.

  The result of the Brexit referendum on June 23rd led to new uncertainties in the European economy and the global economy. Zhu Guangyao believes that in the past few years, the G20 has made achievements in strengthening global economic governance and financial supervision.

  Zhu Guangyao, Vice Minister of FinanceBecause of such a big vibration, the financial market showed its resilience, so after a short-term oscillation, the world financial market returned to a basic stable state. Of course, the medium-and long-term impact of Brexit will continue to emerge, which is why the International Monetary Fund has lowered the growth rate of the global economy several times this year, from 3.6% predicted at the beginning of the year to 3.1% now.

  The world expects China to provide growth momentum.

  Zhu Guangyao believes that with the increasing global economic uncertainty and downward pressure on the global economy, the world has great expectations for the G20 Hangzhou Summit — — It is expected that the Hangzhou Summit will achieve the grand goal of building an innovative, dynamic, coordinated and inclusive world economy. This goal was put forward by China as the presidency in 2016, which shows China’s wisdom and meets the objective requirement that G20 countries and the world need new growth-driven power. Therefore, it is supported by all G20 member countries and welcomed by the world.

  What is the biggest difficulty facing G20? Uncertainty of international economy

  However, what are the biggest difficulties and challenges in the international economic situation facing the G20 Hangzhou Summit?

  Zhu Guangyao believes that the answer is uncertainty.

  Zhu Guangyao, Vice Minister of FinanceThis uncertainty is not only reflected in the differentiation of monetary policies in developed countries; On the other hand, some important emerging market economies are currently facing difficulties, such as Russia and Brazil; Global trade growth is lower than global economic growth … … These factors, coupled with geopolitical risks, constitute the uncertainty of the global economy.

  The G20 plays a key role in stabilizing monetary policy.

  CCTV reporter Zhang YuNot long ago, the Federal Reserve mentioned that the possibility of raising interest rates is increasing, so is it possible for the RMB to depreciate further as it raises interest rates?

  Zhu Guangyao, Vice Minister of FinanceIn terms of exchange rate policy, it is true that G20 finance ministers and central bank governors had in-depth discussions. At the G20 finance ministers and central bank governors meeting held in Shanghai in February this year, two most important policy consensuses were reached, which will also be submitted to the G20 Summit in Hangzhou for approval. The first is to comprehensively use monetary policy, fiscal policy and structural reform policy to promote economic growth; The second policy consensus is about the exchange rate. On the basis of the original policy of G20 Summit, that is, opposing competitive currency devaluation and using exchange rate to gain trade advantages.

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  Zhu Guangyao said that this summit will propose for the first time that G20 member countries should strengthen policy communication on the foreign exchange market, so G20 plays an extremely important role in stabilizing the global financial market and keeping the global exchange rate market basically stable.

  Will the Fed’s interest rate hike further devalue the RMB?

  CCTV reporter Zhang YuG20 Summit Hangzhou Summit is likely to reach such a consensus — — The exchange rate remains relatively stable, that is to say, even if the United States raises interest rates, it is impossible for the RMB to depreciate significantly, right?

  Zhu Guangyao, Vice Minister of FinanceThe exchange rate of RMB first depends on the economic fundamentals of China. When we judge the trend of China’s economy, the most basic understanding is that China’s economic fundamentals are good, China’s economy is resilient, and China’s economy has great room for development. Under this good economic growth prospect, the RMB does not have the basis for continuous depreciation in the long run, so we say so, and in the market, the overall judgment is the same.

  IMF: Optimistic about China’s economic development prospects

  Zhu Guangyao believes that the judgment of the International Monetary Fund and the World Bank on economic growth is particularly important, among which the core policy recommendations come from the International Monetary Fund, which is responsible for monitoring the stability of the global economy and financial markets. Ms Lagarde, the managing director of the International Monetary Fund, and the financial president of the World Bank are highly concerned about the economic growth of China, and at the same time they have made an objective evaluation of the economic development prospects of China.

  CCTV reporter Zhang YuThere is also a very sensitive issue, that is, the issue of economic growth. Now the expectation of future international GDP growth rate has been lowered. Then, at the previous meeting of central banks and finance ministers, what kind of prediction did you have about the economic growth rate of the whole international economy, especially the new economies, and especially China?

  Zhu Guangyao, Vice Minister of FinanceOn the whole, the International Monetary Fund believes that although the global economic growth rate is decreasing in 2016, the prospect of China’s economic development is promising. Therefore, he has lowered the global economic growth rate twice in a row and raised the growth rate of China’s economy. Now the IMF’s judgment on China’s global economic growth in 2016 is 6.6%. This is in line with the economic growth range of 6.5% to 7% in 2016 determined by the China Municipal Government. China’s economic growth rate in the first half of the year was 6.7%.

  China’s economy is still in the three-phase superposition stage.

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  CCTV reporter Zhang YuIn fact, some people in China are worried or feel that the growth rate of 6.7% may be too high, and they feel that this speed is overestimated.

  Zhu Guangyao, Vice Minister of FinanceWhether the actual growth rate of China’s economy is high or low may be different, but the statistical data must be realistic and truly, accurately and completely reflect the actual situation of China’s economic growth. From the figures published by the Bureau of Statistics, the primary industry, the secondary industry and the tertiary industry all have detailed figures to show that they constitute all aspects of economic growth. Only in this way can we make a complete, scientific and accurate judgment. So we think this figure is true and credible.

  At the same time, Zhu Guangyao said that China’s economy is still under the challenge of three-phase superposition, facing the challenges of the adjustment period of economic growth, the analgesia period of economic structural reform and the digestion period of the previous large-scale economic stimulus plan.

  Supply-side reform helps to achieve economic development goals.

  As far as the adjustment period of economic growth is concerned, China has changed from a high growth rate of over 10% to a medium-high growth rate. During the 13th Five-Year Plan period, the average annual growth rate reached 6.5%.

  Zhu Guangyao, Vice Minister of FinanceWe can certainly achieve this goal, because we have both good economic fundamentals and major measures to deepen reform, especially the deepening of supply-side structural reform, which will help us achieve this important development goal.

  China adheres to the market principle in economic development.

 

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  CCTV reporter Zhang YuYou just talked about a very critical issue. The only way out for us to face the challenge is reform. So are there any major reform measures and specific planning schedules in the future?

  Zhu Guangyao, Vice Minister of FinancePromoting reform and opening up is the unshakable policy goal of the central government. At the end of last year, the Central Economic Work Conference set a general tone for the economic development in 2016 — — It means persisting in reform and opening up and striving for progress while maintaining stability. General Secretary of the Supreme Leader repeatedly stressed that there should be major reform measures to enhance people’s confidence in the expectation of economic development in the future. Promote the structural reform of the supply side, de-capacity, de-inventory, de-leverage, reduce costs, and make up for shortcomings … … We are the first to advance in the world. Especially in dealing with excess capacity and high debt ratio, we take the lead in taking action among the major economies in the world; As far as de-capacity is concerned, we unswervingly adopt market principles and adhere to the rule of law. It has been made clear that in the process of de-capacity, mergers and acquisitions should be adopted, which is the principle of the market.

  At the same time, it is necessary to use legal means, including bankruptcy reorganization, reconciliation and liquidation, and gradually promote the rule of law to remove production capacity by law. Therefore, the promotion of supply-side structural reform not only plays an extremely important role in the long-term economic development of China, but also plays an important role in the short-term economic growth. From the perspective of expectation, the market can feel that China is unswervingly pushing forward the reform, especially the structural reform on the supply side.

  G20 central banks and finance ministers will put forward nine suggestions for the summit.

  CCTV reporter Zhang YuSome time ago, six related ministerial meetings, including finance ministers, central bank governors and so on, were held, which basically covered the topics that might be involved in the G20 Hangzhou Summit. So, which of these phased results may eventually be reflected in the outcome of the G20 summit?

  Zhu Guangyao, Vice Minister of FinanceThe report submitted to the summit by the G20 meeting of finance ministers and central bank governors is expected to be approved by the leaders in nine key areas and 48 major guiding principles of structural reform. These nine major areas first include building an open world investment and trade system. The second is to build a dynamic labor market; The third is to promote the implementation of innovation policies; The fourth is the competition policy, which includes improving the business environment; The fifth is to promote the linkage of global infrastructure; The sixth is to establish a perfect global financial system and domestic financial system; The seventh is to promote the reform of the financial system; The eighth is to promote sustainable growth, especially in the environmental field; The ninth major area is an inclusive growth, which can take special care of amblyopia groups and the development of small and medium-sized enterprises. These are the nine major areas.

  It is expected that under the auspices of the Chairman of the Supreme Leader, the Hangzhou G20 Summit will leave a great contribution of China in the history of G20, leaving the mark of China. And promote strong, sustainable and balanced growth of the global economy.

Is Apple’s official APP really safe? The lottery "voted" 120,000 yuan became a bubble.

  Cctv news:APP— — Refers to the software specially built for the mobile network platform. Apple’s mobile phone users must download the APP in Apple’s official app store. Apple explained that the software on the official app store has undergone strict review to provide users with a safer and more reliable experience. Is Apple’s official platform really safe? Mr. Mou, an Apple mobile phone user in Shandong, recently encountered troubles. He suffered heavy losses after downloading an APP marked as "official platform" in the app store.

  In April this year, Mr. Mou from Zibo, Shandong Province, had the idea of buying lottery tickets because of a joke from a friend. He searched for the word "lottery" in his Apple mobile APP store and found a large number of related APPs. Because he had no experience in buying lottery tickets, Mr. Mou downloaded an app marked "official lottery platform" after comparison.

  The words "official platform" and the LOGO of Fucai made Mr. Mou feel very relieved. After reading the operation introduction provided on the APP, Mr. Mou began to bet. In just ten days, he invested 120,000 yuan.

  Gambling APP set a trap to recharge, you must bet.

  The money charged into the APP must be purchased by lottery, and it can only be extracted after winning the prize. Such a rule makes Mr. Mou step by step into the trap. At first, I just wanted to win it back because I lost 8,000 yuan. It was not until I invested more than 100,000 yuan that Mr. Mou became suspicious.

  In the screenshot of the conversation between Mr. Mou and APP customer service staff, it was recorded that the customer service staff claimed to be the official lottery platform to admit that they had their own lottery, which made Mr. Mou stupid. When he carefully checked the recharge record on the APP, he found that every recharge went to different accounts, some were convenience stores and some were hardware stores, which had nothing to do with the so-called "official platform of Chongqing Welfare Lottery". When Mr. Mou checked with Chongqing Welfare Lottery Distribution Center, he realized that he had been trapped.

  It is difficult for users who have suffered serious losses to defend their rights.

  Chongqing Welfare Lottery Distribution Center made it clear that the state prohibits the online sale of lottery tickets. Why did you download an APP named "Chongqing Welfare Lottery Official Platform" in Apple’s app store? Mr. Mou, who suffered losses, began to defend his rights from Apple at the end of April.

  Since April 24th, Mr. Mou has repeatedly called Apple’s customer service hotline to reflect his experience. Although Apple provided the corresponding acceptance number for Mr. Mou’s complaint, it never gave a reply.

  On April 27, Mr. Mou came to Apple’s office in Pudong, Shanghai, and asked Apple to provide the information of the actual registrant of the APP pretending to be the official platform of Chongqing Welfare Lottery and provide corresponding financial compensation, but the staff refused. Later, Mr. Mou sent an email to Apple’s headquarters in the United States, reflecting the scam he encountered and asking the other party to provide information about the APP involved, but Apple’s reply did not respond to Mr. Mou’s request.

  Mr. Mou has been communicating with Apple for more than 50 days in Shanghai, and Apple has never provided him with relevant information about the APP involved. Mr. Mou, who plans to defend his rights through litigation, has no way to provide complete materials to the court. On July 16th, the reporter and Mr. Mou came to the Apple Company at No.391 Yuanshen Road, Pudong District, Shanghai. The staff refused to let the reporter and Mr. Mou in on the grounds of safety, and there was only one way to reflect the problem, that is, to fill in the form, leave a phone number and wait for the reply from Apple.

  Online lottery tickets completely prohibit illegal apps from still existing.

  Apple refused to provide Mr. Mou with the registration information of APP suspected of gambling and impersonating the official platform on the grounds of user privacy and safety, but Mr. Mou found that many users using Apple mobile phones reported similar lottery scams on some online complaint websites, many of which were cheated by hundreds of thousands, and some were tens of thousands. And how did the APPle App Store, which claimed to be strictly audited, get these illegal apps under the official banner mixed in?

  On July 19th, when a reporter typed in "lottery ticket" in the APPle App Store, hundreds of apps appeared. Among the top 30 apps, three were marked with the striking words "official version" on their icons, and four were marked as "official authoritative platforms" in the developer’s name, all of which were marked with five-star full marks.

  An APP named "Welfare Lottery" uses a similar shape and color scheme to China Welfare Lottery. The developer’s name reads "2018 Official Authoritative Lottery Platform". After entering the download page, the reporter found that the developer’s name of the platform was marked as "Hubei Zhenxin Lottery Culture Development Co., Ltd.". When the reporter downloaded the APP and opened it, he found that the platform was titled "22 Lottery". In the interface of the APP, there are Chongqing Shichai, Beijing PKS, Hong Kong Mark Six Lottery, etc. Users want to bet on the platform first. Recharge. In the introduction of this APP, the reporter did not find any information authorized by the official platform of welfare lottery.

  After logging in to official website, China Welfare Lottery Distribution Management Center, the reporter found that as early as the beginning of April this year, in view of the problem of using the Internet to sell welfare lottery tickets in Jiangsu, Ningxia and other five provinces and regions, China Welfare Lottery Distribution Management Center issued an announcement, clarifying that "welfare lottery institutions at all levels and welfare lottery agents must standardize their sales behavior and must not cooperate with any unit or individual to use the Internet to sell welfare lottery tickets in violation of regulations."

  Since China has banned the sale of lottery tickets on the Internet as early as 2015, why can the APP that sells lottery tickets in Apple’s app store become popular and even pretend to be an official platform to attract users? The reporter conducted a survey on a number of Internet companies providing APP platforms in Shanghai, Jiangsu and other places, and found that no one refused to develop lottery-related APPs. As long as they spend money, they can be put on Apple’s app store.

  In addition to promising to get through the channel of putting the lottery APP on the APPle App Store, the technician also revealed to reporters the loopholes in Apple’s app review.

  Illegal APP borrows vest to escape supervision.

  By using the technical means of changing the code keywords in the APP, it can pass the audit of APPle. Such a flaw makes a large number of illegal apps exist in the Apple App Store. Through the investigation, the reporter found that Apple also has serious loopholes in the content supervision after the APP was put on the shelves. An illegal APP can generate multiple apps by grafting flowers and trees, which is also called "casing" in the black industry chain of the Internet.

  Network security researchers showed reporters that there are a lot of gray or even black transactions in Internet forums. Some people ask how to shell the APP in Apple’s IOS system, and some are selling the shell code of the APP. And Mr. Mou from Shandong downloaded the "Lottery Recommendation — The official platform has also appeared the phenomenon of casing in use.

  With the name of an APP, the name can be changed through background operations. The practice of changing the vest in this way is to escape supervision and illegally collect money.

  Although APPle announced the review process of the APP, emphasizing that "APPs involving games, gambling and lottery tickets can only include this function after fully verifying the relevant legal requirements of all countries/regions of the upcoming app", the reporter found through investigation that there were serious review loopholes in the Apple App Store from qualification to content. According to the Regulations on the Management of Mobile Internet Application Information Services issued by the National Network Information Office in 2016, "Mobile Internet application providers should strictly implement the responsibility of information security management, establish and improve the user information security protection mechanism, and protect users’ right to know and choose during installation or use according to law, and respect and protect intellectual property rights." Zhu Wei, one of the drafters of this regulation and deputy director of the Communication Law Research Center of China University of Political Science and Law, said that users’ interests were damaged due to the confusion of platform management, and they should take the initiative to take responsibility to prevent more serious consequences.

Flash! CDE issued the Technical Guiding Principles for Pharmaceutical Research and Evaluation of Specific Human Immunoglobulin.

      In order to standardize and guide the R&D, production and registration of specific human immunoglobulin, and further clarify the technical evaluation standards, under the deployment of National Medical Products Administration, the Drug Testing Center organized and formulated the Technical Guiding Principles for Pharmaceutical Research and Evaluation of Specific Human Immunoglobulin (see Annex).
       According to the requirements of the Notice of the General Department of National Medical Products Administration on Printing and Distributing the Release Procedures of Drug Technical Guidelines (No.9 [2020] of the General Administration of Drug Administration), with the approval of National Medical Products Administration, it is hereby promulgated and shall come into force as of the date of promulgation.
       This is for your information.

       Appendix: Technical Guiding Principles for Pharmaceutical Research and Evaluation of Specific Human Immunoglobulin
National Medical Products Administration yaoshen center
May 20, 2022   
I. Overview

Specific human immunoglobulin (HIG) is a highly effective immunoglobulin preparation prepared from plasma containing specific antibodies.

The sources of plasma include plasma with high titer antibody after the patient recovered from infection with a pathogen, and plasma containing specific antibodies by hyperimmune injection of healthy blood donors, that is, injection of vaccines or other antigens to make the injected people produce antibodies. Specific human immunoglobulin (hereinafter referred to as "special immune product") is an indispensable blood product because it contains specific antibodies with high titer, and its effectiveness in preventing and treating specific diseases is better than that of ordinary human immunoglobulin.

In order to encourage, standardize and guide the research and development of special exemption products, this guiding principle is formulated with reference to the relevant technical requirements at home and abroad and combined with the actual situation in China. This guiding principle is only based on the current technical development and scientific cognition, aiming at the general pharmaceutical research technical requirements of special exemption products. The applicant/holder can also adopt other more effective methods and means according to the actual situation of the research and development of the exempted products, but it should conform to the law of drug research and development and provide scientific and reasonable basis to ensure the safety, effectiveness and controllable quality of the products. 

Second, the scope of application 

These guiding principles are applicable to the special immunity products made of specific antibody plasma obtained by direct screening of specific antibody of plasma donors and active immunization. They have similar product characteristics and pharmacological characteristics, and their pharmaceutical requirements are both common and different. At present, the varieties included in People’s Republic of China (PRC) Pharmacopoeia (hereinafter referred to as China Pharmacopoeia) include hepatitis B human immunoglobulin, rabies human immunoglobulin, tetanus human immunoglobulin, etc. The research and development and registration of special exemption products at home and abroad are shown in Schedule 1, and the modes of administration are divided into intravenous injection, intramuscular injection and subcutaneous injection.

III. General principles 

1. Security. 

Because of the particularity of blood products, there is a potential risk of virus pollution, and virus safety control is the core content of blood products quality control. The collection, inspection, storage, transportation, traceability and the immune requirements of plasma donors of the plasma exempted products shall conform to the provisions of "Plasma for Blood Products Production" in China Pharmacopoeia and "Quality Management Standard for Plasma Collection Stations". It is suggested that screening research on B19 and other pathogens should be carried out according to product characteristics and clinical users, especially some special varieties (such as anti-D immunoglobulin). It is suggested that the applicant/holder cooperate with relevant departments to carry out epidemiological monitoring in the area where the plasma station is located. Actively promote the detection technology of nucleic acid in raw plasma and mixed plasma, and formulate standards and requirements. Special attention should be paid to the epidemic situation and detection methods of new and sudden infectious diseases.

2. Specific antibody screening. 

The accuracy and reliability of specific antibody screening results is the key to ensure the quality of raw plasma. In the case of large-scale production, the amount of single plasma detection involved is large, so it is necessary to establish a suitable antibody titer detection method and fully verify it by the method in the early stage of research and development. Single plasma can be screened for specific antibodies by immunolabeling method, and the correlation between binding titer and neutralization titer can be established. The combined plasma, stock solution and preparation shall be tested for specific antibodies by the method specified in China Pharmacopoeia or the verified method. Usually, based on virus neutralization test (mouse neutralization test, micro-cell lesion count and plaque reduction test), immunolabeling test (enzyme labeling, fluorescence labeling, isotope labeling, etc.), hemagglutination inhibition test, immunodiffusion test, immunoturbidimetry test or other immune/biochemical tests, the research is carried out by quantitative and semi-quantitative methods based on reference materials.

3. Production technology 

The process development of this kind of products can refer to the process of similar products that have been listed, and platform technology can be used. The use of chromatography is encouraged to improve the purity of products, but the selection of chromatographic parameters and the influence of the quality of chromatographic resin on the quality of products should be fully considered, and the inactivation and removal ability of viruses by the process should be paid special attention to. The verification of virus inactivation/removal should meet the requirements of General Principles of China Pharmacopoeia "Virus Safety Control of Biological Products", "Technical Methods and Verification Guidelines for Virus Removal/Inactivation of Blood Products" and technical documents such as ICH and WHO.

Management rules and operating procedures should be established for personnel safety protection and wastes in the production process, bioactive substances and viruses should be inactivated according to proven inactivation treatment methods, and effective protective measures should be taken to protect operators to avoid risks such as virus transmission.

Four, pharmaceutical research and evaluation points 

(1) Raw plasma and materials for production 

1, plasma source and quality control 

Quality control of single plasma: single plasma must meet the relevant quality control requirements issued by the national health administrative department. Raw plasma used for production must have legal sources (plasma station certification documents, etc.) and pass inspection and quarantine, and should have complete reagent data (marketing certification documents, etc.) and screening records (antigens/antibodies/nucleic acids) for screening blood-borne infection markers.

Immune procedure: immune procedure and dosage of antigen used are the key factors to determine the concentration and titer of antibody in plasma. It is necessary to define the immunization methods. For example, when active immunization is carried out with approved vaccines or other antigens, these immunogens should have complete source certification information and batch information. The immunization program should refer to the requirements of vaccine instructions, or be formulated according to the immunogenicity of antigen and the reactivity of plasma donors, but the specific immunization program adopted should prove its safety. Subjects should have full right to know, and at the same time make corresponding countermeasures for possible problems. 

Quality control of mixed plasma: A certain amount of plasma should be mixed, which should meet the requirements of China Pharmacopoeia in combination with product characteristics. At present, ordinary people are required to mix the plasma of at least 1000 plasma donors. Specially exempted products generally require plasma mixing from at least 100 plasma donors, except for some special varieties (such as anti-D immunoglobulin products).

No matter the plasma obtained by active immunization with approved vaccine or immunogen or the plasma immunized after natural infection, the specific antibody content standard of each plasma and combined plasma should be formulated at the time of IND declaration. The plasma whose antibody level is up to the standard is used for plasma production. For varieties that have not been recorded in China Pharmacopoeia, there should be a clear basis and a proven detection method for determining the titer of specific antibodies in raw plasma and preparations. When NDA is declared for the varieties included in China Pharmacopoeia, the antibody titer standard should not be lower than the requirements of China Pharmacopoeia.

2. Raw materials for production 

Strict quality control of raw materials used in the production of special exemption products is a necessary measure to reduce the risk of contamination by exogenous factors or toxic impurities in products and avoid the activation of other factors in plasma. In addition to clear sources, quality standards and inspection reports, raw materials for production should also focus on the use of animal-derived raw materials (such as heparin) and avoid using animal-derived raw materials as much as possible. TSE/BSE risk assessment should be conducted for raw materials used in production. 

When using filter AIDS (perlite, diatomaceous earth, etc.), filter membranes and filter element materials in the separation process, it is necessary to establish appropriate quality control standards according to the requirements of different process stages, control the introduction risk of exogenous factors, control bacterial endotoxin and heavy metals, and formulate reasonable limit requirements. In addition, it is necessary to pay attention to the risk of residues that may be mixed into the final product and potentially harmful to human body, and control them if necessary.

(2) Production technology 

1. Stock solution 

The initial raw material of the special immunity products is raw plasma or plasma components. The modified Cohn method or KistlerNitschmann method can be used to separate the special immunity products, and other methods can also be used for separation and purification, such as octanoate precipitation and chromatography. 

The separation and purification process adopted should ensure that the physicochemical and biological properties of the product and the biological activity of the Fc segment of IgG are well preserved. The production process must avoid or eliminate the pollution of microorganisms (bacteria, viruses) and their metabolites (pyrogens) to the maximum extent. It is necessary to strengthen the control of production process and consider the influence of the removal of filter AIDS and the selection of filter media on the products. It should be paid attention to that IgG fractions obtained by different separation methods may contain higher levels of IgA and IgM. At the same time, attention should be paid to the rationality of sterilization and filtration steps, and the integrity of the filtered membrane should be checked.

It is necessary to specify the amount of slurry for pre-clinical, clinical samples and market-scale samples. Generally, continuous production should be carried out, and the production capacity of each process step should be matched with each other, and the processing should be completed at one time. In each process step, it is the key to determine the process control parameters and scope and meet the requirements. When using ethanol and other precipitation methods, it is necessary to control the quality of ethanol and other reagents, and study the protein concentration, temperature, pH value, ionic strength, treatment time and so on, so as to define the acceptable limit range. In the process of dissolution and precipitation of plasma components, avoiding IgG coprecipitation is the key to improve the product yield, especially the key indexes such as temperature and adding time should be fully studied to investigate the influence on the key quality indexes such as protein purity and molecular size distribution. When chromatographic method is used, it is necessary to optimize chromatographic conditions and determine reasonable parameters according to the nature and concentration of protein in the product, such as the capacity of chromatographic column, ionic strength of feed solution and buffer solution, pH value of buffer solution, flow rate, contact time and temperature, etc. The determination of these parameters should be based on the research data of process development, and limit standards and allowable ranges should be formulated. At the same time, it is necessary to study the cleaning and regeneration (service life) of chromatographic resin, the load of chromatographic column and the extract, especially the use of chromatographic packing with potentially harmful ligands. It is necessary to pay attention to the volume, protein concentration, recovery rate and electrophoretic purity of each separation and purification step, and evaluate the process-related impurities (such as ethanol, sedimentation aid, IgA, aluminum, heavy metal ions, etc.) and product-related impurities.(such as polymers, etc.). If necessary, in order to prove the ability of the process to remove impurities, it may be necessary to use standard addition test to evaluate the ability of the process to remove some potential pollutants. If operations that may affect product quality, such as temporary storage and transportation of intermediate products, need to be supported by necessary stability research data.

Encourage the use of innovative and improved processes (including the improvement of ethanol separation process) to improve the utilization rate of plasma and improve the quality of special exemption products. In the early stage of process development, attention should be paid to the identification of key process parameters, the integrity of process control in different separation stages and the rationality of process parameter setting. If the applicant/holder has already marketed products with the same separation and purification process, and the existing process research data and control parameters can be used for reference, the process verification of three batches of new special exemption products should be carried out. 

Considering the preciousness of plasma resources, the pilot-scale research data suitable for clinical trials can also be used for the declaration of IND stage. However, when applying for NDA, it is necessary to have complete commercial scale research data.

2. Preparation 

Clarify single prescription and batch prescription, and explain the basis of rationality of preparation prescription. Auxiliary materials suitable for medical use should be used, and the stability of the supply chain should be ensured. For accessories from multiple suppliers, it is necessary to carry out full research. For brand-new excipients that have not been used in similar preparations at home and abroad, a comprehensive study should be carried out and related declarations should be made. No bacteriostatic agent shall be added to the special exemption products for intravenous injection. Because some cosolvents (such as polysorbate 80) have the potential risk of causing allergic reaction and hemolysis reaction, safety evaluation should be carried out. The preparation process (such as stirring speed) should be studied. In principle, the preparation of semi-finished products should come from a batch of stock solutions. If different batches of stock solutions are used to prepare semi-finished products, the possible risks should be evaluated.

The temperature of products, the duration of packaging, the temperature and humidity of packaging environment should be controlled. Special exemption products involving freeze-drying technology should have data such as freeze-drying process parameters and freeze-drying curves verified by commercial batches, indicating the influence of freeze-drying technology on product quality, especially on biological activity.

3. Process verification 

For the products exempt from intramuscular injection, it is necessary to determine the process flow and key process parameters before NDA declaration, and continuously produce three batches of products to verify the stability of the process, so as to provide a supporting basis for the products to go on the market. For the special exemption products for intravenous injection, the process flow and key process parameters should be determined as far as possible before the confirmatory clinical trial, and the stability of the process should be verified by continuous production of three batches. If there are differences between clinical trial samples and commercial scale batches in terms of production technology or site, it is suggested to carry out change research, and it is suggested to carry out research and exploration on the worst process conditions at an appropriate stage, and it is necessary to prove that qualified products can be produced under the determined process parameters and quality control limits. If multiple production sites or production lines are involved, verification research should be carried out. 

(III) Virus safety and virus removal/inactivation verification 

The detection of single plasma and mixed plasma should meet the requirements of China Pharmacopoeia, and the number of cases of mixed plasma should meet the sensitivity requirements of the kit/detection method. For anti-D immunoglobulin, the nucleic acid load of B19 virus in plasma should be ensured to be less than <104 IU/ml.

Because of the differences in the ability of inactivation/removal of lipid-coated and non-coated viruses by various methods, it is recommended to use two virus inactivation/removal methods with different mechanisms to carry out verification, and to clarify the technical conditions and control parameters of virus inactivation/removal process steps, including product uniformity, upper and lower temperature limits, inactivation time, filtration pressure/speed/temperature/solution composition/membrane integrity, etc. Attention should be paid to the rationality of setting the position of deactivation/removal process steps. When selecting virus removal/inactivation method, the effect of virus inactivation/removal should be balanced with product activity and general safety. 

It is necessary to consider the potential interaction between inactivation steps, the influence of inactivation process on antibody integrity and clinical efficacy, whether new immunogens are formed and the risk of toxic residues that may be introduced. If the production process changes, which may affect the virus removal ability, it needs to be verified again. In addition, the samples used for inspection should be representative of the process. With the development of technology, some new methods of virus inactivation can also be applied in special exemption products, which need to be proved to be scientific and effective and fully verified.

If the products with the same process steps have been approved and registered, and the virus inactivation/removal process has been verified, the newly declared products will only change the mode of administration, and the products with the same production equipment, process and operation as the original products in commercial batches can not be subjected to virus inactivation/removal process repeatedly on the premise of meeting the relevant technical requirements such as Technical Methods and Verification Guidelines for Removing/Inactivating Viruses from Blood Products and Technical Guidelines for Pharmaceutical Change Research of Listed Biological Products.

In order to ensure the virus safety of the final product, we should consider the setting of plasma station from epidemiological data, strictly select plasma donors, screen plasma and manage the quarantine period, optimize the production process and add virus removal/inactivation steps, and evaluate the virus removal ability of the whole process steps of producing products. To evaluate the virus inactivation/removal ability of the production process and the maximum load of specific virus that may exist in the initial plasma, and to ensure the virus safety of the product to the greatest extent, it is necessary to ensure that the verification includes the worst case.

(D) Quality research and control 

1. Analysis of physical and chemical characteristics 

It is necessary to gradually improve the analysis of physical and chemical characteristics in combination with product types, preparation types and drug development stages. IND declaration can be made based on the preliminary research data of physical and chemical characteristics, and NDA declaration should be made by comparing the physical and chemical characteristics, including antibody integrity, antibody subtype distribution, circular dichroism analysis, etc.

2. Biological activity 

Biological activity research should be fully carried out, and it is suggested to study the correlation between binding titer and neutralization titer detection methods. From the aspects of supporting the rationality of the process and considering the influence of the process on the product, it is suggested to establish a method for detecting the biological function of Fc, and to study the sialic acid content of Fc segment in the development stage. Production technology, antibody titer, IgG polymer, IgG subclass, etc. will affect the results of biological function test of Fc. In addition, it is suggested to analyze the binding ability of Fc segment to immune cell surface receptors, the activation of complement function by Fc segment, and the regulation of phagocytosis.

3. Purity and impurities 

Attention should be paid to the components that affect the function of this kind of products, and the purity is generally not less than 95%. In addition to carrying out research on impurity residues and proving the ability of the process to remove impurities, the impurity level limits of batches at different stages (if there are clinical and commercial batches) should be set reasonably. It is suggested that a sensitive method should be used to control the content of impurity protein. 

Polymers produced during the preparation of special immunity products are related to anti-complement activity (ACA), and the content of IgG polymers should be controlled. In order to prevent patients with congenital IgA deficiency from causing serious allergic reaction after using special immunity products, the content of IgA should be controlled. The content of anti-A and anti-B hemagglutinin should be studied and the limit standard should be established to prevent hemolytic reaction caused by large amount of infusion. Encourage the detection of coagulation activator levels and establish standards. It is suggested that anti-D antibody detection should be carried out for intravenous special immunity products from special plasma sources. In addition, in order to prevent the risk of thrombosis, it is suggested to control the FXIa content of intravenous special immunity products and establish standards.

Encourage the detection of other miscellaneous proteins in blood, such as kallikrein activator, immunoglobulin M, transferrin, albumin, α1- antitrypsin, α2 macroglobulin, haptoglobin, α1- acidic glycoprotein, ceruloplasmin, fibrinogen, antithrombin III, plasminogen, fibronectin and C1 esterase inhibitor.

Special exemption products, especially those for intravenous injection, should also focus on the control of insoluble particles. Insoluble particles can not be metabolized in human body, and it is easy to induce thrombosis if they stay in tiny blood vessels. The content of aluminum should be controlled. Aluminum has potential risks to the central nervous system, bones and other organs, and this risk is related to the infusion dose.

4, quality analysis and standards 

The listed special exemption products should meet the requirements of China Pharmacopoeia, and the rationality of testing items should be fully considered for new special exemption products. Quality standards should be set reasonably according to the characteristics of products with different administration methods, such as intravenous special exemption products, and FXIa factor, aluminum ion and IgA content should be increased.

When applying for IND, special attention should be paid to antibody titer, harmful residues and other related testing items.

When applying for NDA, the quality standards of stock solution, semi-finished products (if any) and preparation should be reasonably drawn up based on the data of various research and development stages and stability inspection, on the basis of statistical analysis of multiple batches, combined with the requirements of China Pharmacopoeia and the situation of similar products, with emphasis on the quality control of potency, and more stringent internal control standards should be encouraged. Advanced and mature methods should be used for titer detection, and various complementary analysis methods should be encouraged for quality control in the early stage of research and development. If auxiliary materials such as maltose, polysorbate 80 and glycine are added to the preparation, it should be controlled in the quality standard of the preparation and its content range should be defined.

5, analysis method and methodology verification 

Combined with the characteristics of products, select a reasonable analysis method and carry out sufficient methodological verification to ensure the feasibility of the method.
At the time of IND declaration, at least the preliminary verification of antibody titer and harmful residue detection method should be completed.

When applying for NDA, a complete analysis method should be established and verified. Clarify the accuracy, precision (including repeatability, intermediate precision and reproducibility), specificity, detection limit, quantitative limit, linearity, range and durability of the determination method. Methods other than those in China Pharmacopoeia should be fully verified when applying for NDA. If the determination method is changed greatly, the scope of re-verification should be determined according to the degree of revision of the method.

Establishment and verification of antibody titer detection methods: research on product-specific antibody titer detection methods and standards should be carried out before research and development. It is suggested to study the correlation between binding titer and neutralization titer detection methods. Try to use the method of China Pharmacopoeia, and try to choose the classic and industry-standard method for those not included in China Pharmacopoeia. Clarify the test operation flow, test parameters, preparation and calibration of work standards and criteria for judging results. According to the antibody titer detection method itself, select appropriate indicators to carry out methodological verification and establish verification scheme. Generally speaking, in terms of linearity, the correlation coefficient of neutralization titer determination method should meet the pre-set acceptable standards. In terms of accuracy, the ratio between the actual titer of neutralizing antibody and the theoretical titer of serum with different dilution times is 1, or the slope of regression line in covariance analysis is parallel. In terms of precision, the coefficient of variation should be controlled within 30% as far as possible. In terms of durability, it is necessary to investigate the effects of cell density (generation), neutralization virus dose, neutralization reaction conditions and time, and different positions of orifice plates on the test results. In order to study the influence of possible degradation products and degradation pathways on titer determination, the samples can be destroyed by accelerated methods such as strong light irradiation, high temperature and high humidity. Encourage the use of working standards as quality control, reduce test interference factors, and improve the accuracy and reliability of results.

Verification of detection methods for hazardous residues: Usually, hazardous residues are at trace level, and the sensitivity of detection methods determines the reliability of the results. Encourage the use of more advanced methods and instruments with higher sensitivity based on the methods in China Pharmacopoeia, and pay attention to distinguish the detection limits of instruments and methods. The obtained detection limit and quantitative limit data must be verified by samples with similar contents.
say
Test process and detection limit results, including accuracy and precision verification data. The linear indexes such as recovery rate (%) and relative standard deviation (RSD%) should be listed as regression equation, correlation coefficient, residual square sum linear graph, etc. The range should be drawn up within 20% of the specified limit according to the preliminary measured data, and in general, various methods with different principles should be used to verify each other. Methodological verification of product-related impurities: Methodological verification shall be carried out according to the requirements of China Pharmacopoeia. If the commercial kit is used for residue detection, it is suggested to study the selection of detection kit (such as IgA detection), and the detection kit should explain the sensitivity, specificity, detection limit, quantitative limit and linear range. In general, the accuracy, precision, linear range, interference test, reference interval and other indicators of the kit should be verified. The variation coefficient of precision should be within 20%, the accuracy deviation should not exceed 10%, the linear range determination coefficient (R 2) should be ≥ 0.98, and the relative deviation of interference test should be less than 10%. Attention should be paid to identify the factors that affect the accuracy of the determination results during the release test of products, such as pH value, PK activity, ionic strength of product solution, reaction temperature, etc., which will affect the determination results of PKA, and low pH conditions may reduce the PKA activity of products. 

6, reference (standard)

The quality control reference of antibody titer should be established according to the requirements of relevant guiding principles. When applying for NDA, it is necessary to clarify the key information such as the source and quality control of reference materials, and the reference materials should be related to the samples used in clinical experiments, paying attention to the accuracy and traceability of assignment. If international/national standards are adopted, the information of standards used (source, batch, etc.) shall be specified. If it is a self-made reference, the preparation process, calibration and stability should be studied.

(5) Stability study 

Stability test runs through the whole product life cycle and is the basis for formulating product standards and expiration dates. The stability test should be carried out in accordance with the China Pharmacopoeia and the relevant guiding principles of stability research of biological products at home and abroad. In the declaration stage of IND, preliminary stability inspection can be conducted to ensure the quality of samples in clinical stage. Complete a comprehensive stability inspection before NDA declaration, select suitable packaging materials, define storage and transportation conditions, and formulate a reasonable validity period. The investigation of influencing factor test and accelerated test should be studied as far as possible until the product is unqualified. Long-term stability investigation should extend the observation time of products as much as possible. In general, the liquid dosage form should be placed upside down and upright for stability test. Products with different closed systems should be tested for stability respectively. If a new production site is introduced to produce intermediate products, unless there are other reasons, the stability research of intermediate products and finished products should be carried out. The activity of Fc segment is an important indicator of the effectiveness of this kind of products, so it is suggested to investigate the related stability. For the special exemption products in liquid dosage form, the thermal stability test should be carried out, and the visible foreign bodies should be checked. The results should meet the requirements of China Pharmacopoeia.

(6) Packaging and sealing container system 

The source and control standard of inner packaging materials should be clarified, and the compatibility and sealing of packaging materials should be studied in accordance with the relevant guiding principles such as Technical Guiding Principles for Compatibility Research of Chemical Injection with Medical Glass Packaging Container (Trial Implementation), Technical Guiding Principles for Compatibility Research of Chemical Injection with Plastic Packaging Materials (Trial Implementation) and the requirements of ICH related guidelines. Extracts, dissolved substances, sloughs, etc. shall meet the limit requirements. Pay attention to the influence of the extract of inner packing rubber stopper and glass bottle on the preparation. 

V. Explanation of nouns

1. Blood Products refer to therapeutic products derived from human blood or plasma, such as human albumin, human immunoglobulin, human coagulation factor, etc.

2. Human Normal Immunoglobulin (HNIG): also known as gamma globulin or multivalent immunoglobulin, is an immunoglobulin preparation separated from healthy human plasma by low-temperature ethanol protein separation method or other approved protein separation methods, including intravenous immunoglobulin, intramuscular immunoglobulin and subcutaneous immunoglobulin.

3. Specific human immunoglobulin (HIG): It is a high titer immunoglobulin preparation prepared from plasma containing specific antibodies. The sources of plasma include plasma with high titer antibody after the patient recovered from infection with a pathogen, and plasma containing specific antibodies by hyperimmune injection of healthy blood donors, that is, injection of vaccines or other antigens to make the injected people produce antibodies. Different from ordinary immunoglobulins, such preparations must have at least one high titer antibody for the prevention and treatment of specific diseases in clinic.

4. Anti-complement Activity (ACA): A substance in serum or tissue fluid that can nonspecific bind to complement and make it inactive, such as protease and ester. 

VI. References (omitted)

Network operators need the consent of guardians to collect and use children’s personal information.

  China. com May 31 (Reporter Zhang Yanling) The National Internet Information Office today issued the Regulations on the Protection of Children’s Personal Information Network (Draft for Comment), which clearly stipulates that network operators should obtain the express consent of children’s guardians if they collect, store, use, transfer or disclose children’s personal information.

  The opinion draft stipulates that network operators should set up special, concise and easy-to-understand rules and user agreements for the protection of children’s personal information, and set up personal information protection commissioners or designate special personnel to be responsible for the protection of children’s personal information.

  The collection and use of children’s personal information requires the consent of the guardian.

  When collecting and using children’s personal information, network operators shall inform children’s guardians in a significant and clear way. When using or transferring children’s personal information with a third party, they shall conduct safety assessment by themselves or entrust a third party organization, and shall obtain the express consent of children’s guardians. However, in order to safeguard national security or public interests and eliminate the urgent danger of children’s personal or property, the express consent of the child’s guardian may not be required.

  When the network operator obtains the consent, it shall also provide the refusal option, and clearly inform the purpose, scope, manner and time limit of collecting, storing, using, transferring or disclosing children’s personal information; The storage place of children’s personal information and the way to deal with it after it expires; Security measures for children’s personal information; Personal information protection Commissioner or other contact information; Information such as the consequences and effects of rejection.

  The opinion draft stipulates that network operators should not store children’s personal information beyond the time limit necessary for their collection and use purposes and the agreed purpose and scope, and should take encryption and other measures to store children’s personal information to ensure information security.

  Network operators shall not disclose children’s personal information, except those that should be disclosed according to laws and administrative regulations or need to be disclosed according to the agreement with children’s guardians.

  Correction of children’s personal information errors, deletion of illegal use

  Children or their guardians have the right to ask network operators to correct the personal information of children collected and stored by them. Network operators should take timely measures to correct them.

  Network operators collect, store, use, transfer or disclose children’s personal information in violation of laws, administrative regulations or user agreements; Collecting, storing, using, transferring or disclosing children’s personal information beyond the scope of purpose or the necessary period; The guardian of the child withdraws his consent; If a child or his guardian terminates the use of a product or service by means of cancellation, and the child or his guardian requests the network operator to delete the personal information of the child collected, stored and used by him, the network operator shall take timely measures to delete it.

  Information leakage should be remedied in time and reported to the competent department.

  The opinion draft makes it clear that if the network operator finds that children’s personal information is or may be leaked, damaged or lost, it should immediately start the emergency plan and take remedial measures; If it has caused or may cause serious consequences, it shall immediately report to the relevant competent authorities, and inform the affected children and their guardians of the incident by mail, letter, telephone, push notice, etc. If it is difficult to inform them one by one, it shall release relevant warning information in a reasonable and effective way.

  If the network operator stops operating products or services, it shall immediately stop collecting children’s personal information, delete the children’s personal information it holds, and inform the children’s guardians of the notice of stopping operation in time.

  There are security risks, and network operators will be interviewed.

  According to the opinion draft, if the responsibility of network operators to implement the safety management of children’s personal information is not in place, there is a big security risk or a security incident, the National Internet Information Office will conduct an interview according to law, and the network operators should take timely measures to rectify and eliminate hidden dangers according to the interview requirements.

  If the violation is serious, close the website and revoke the business license.

  In violation of these regulations, the National Internet Information Office and other relevant departments have issued orders to make corrections, and according to the circumstances, they may be given a single warning, confiscate the illegal income and impose a fine of more than one time and less than ten times the illegal income. If there is no illegal income, they shall be fined less than one million yuan, and the directly responsible person in charge and other directly responsible personnel shall be fined more than 10,000 yuan and less than 100,000 yuan. If the circumstances are serious, it may be ordered to suspend relevant business, suspend business for rectification, close the website, revoke the relevant business license or revoke the business license; If a crime is constituted, criminal responsibility shall be investigated according to law.

  Anyone who is investigated for legal responsibility in violation of these provisions shall be recorded in the credit file in accordance with the provisions of relevant laws and administrative regulations and publicized.

Drive shaft problem solved! Red Flag HS5 Long-term Test (11)

  [car home Long-term Test] Hello, everyone, the long-term test article of Hongqi HS5 has suddenly been updated! Surprise or surprise! I said in the article before that it will only be updated again when there is a problem with the vehicle. So what new tricks did the red flag HS5 "play" for us this time?

Home of the car

  Friends who have been paying attention to the long-term test articles all know that the transmission shaft of our HS5 is shaking when the vehicle is driving at high speed, and they have long said that they want to replace it. Recently, they finally made time to replace the transmission shaft, and this time they also did the third maintenance, replacing the right front headlight assembly and the back seat.

  On a sunny afternoon, we were about to go out to work. When we walked to the front of the car, we suddenly found that the turn signal strip of the headlights on the right front of the car was strobed and unlit. Although it did not affect driving, we could not let it pass.

● Please see the video for details.

More exciting videos are all on the car home video platform.

● Start with the third maintenance.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  Ok, after reading the problems of this car, let’s see how the 4S shop solves them one by one, starting with the third maintenance! This maintenance is the third maintenance of this car. In this maintenance, not only the routine items such as replacing the oil filter and air conditioning filter, but also the spark plug were replaced.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  After reading the maintenance bill, let’s take a look at the "claim" bill. We also replaced the left front wheel harness assembly, the transmission shaft assembly, the right front headlight assembly and the back seat back when we entered the factory. These items add up to a total value of 10,682.46 yuan, of which the most expensive is the headlight assembly with a price of 4,485 yuan. These items are also replaced free of charge, with free parts and no working hours.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  I want to explain here that some people in the previous article questioned whether I used low-quality fuel to reduce the life of the spark plug. Here I tell you responsibly that this car has been refueling at Sinopec and has never been to those "brand-name" gas stations. As for the maintenance cost, the car is still within the free maintenance period, so the maintenance cost is still in 0 yuan.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  In fact, I didn’t find the problem of the back of the chair, because as a work car, there are few people sitting in the back of this red flag HS5. The staff of the 4S shop told me that it is a common phenomenon that the rear seat is cracked, and many car owners have already replaced it, so I also need to replace it. Since it doesn’t cost money, of course I have to change it! After the replacement, the covering layer on the surface of the new chair back is "pressed" into the sewing thread, so the improvement reduces the probability of glue opening.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  The problem of our HS5 transmission shaft has always existed, but it doesn’t affect driving too much, so it has been dragged on, and this time it finally took time to replace it. The transmission shaft is the main component to transmit power. If it has problems, the vehicle will produce jitter and noise. When the speed of our car is 120km/h, the jitter of the transmission shaft is the most obvious, and the driver can clearly feel it from the steering wheel, which affects the driving experience.

FAW Hongqi Hongqi HS5 2019 2.0T Zhilian Banner enjoys the four-wheel drive version.

  The 4S shop replaced a new drive shaft for our car. The new drive shaft optimized the workmanship at the joint, and both ends of the shaft were finely upgraded. After the replacement, it really stopped shaking and stabilized when driving at high speed, so those car owners who have the same problem as us quickly went to the 4S shop to replace it without spending money.

● Stable fuel consumption.

Home of the car

  So far, this HS5 has traveled 30,000 kilometers in our hands. Because the driving route and working conditions are basically the same, the performance of fuel consumption level is very stable, and the fuel consumption performance of 10.4L/100km is normal.

● Summary:

  This is the eleventh issue of this long-term test article. Several problems have been solved smoothly, and no money has been spent. However, the problems in headlights, rear seats and transmission shafts are really inappropriate. It is not easy to establish word of mouth, but it is very simple to fall down. Quality control management is a difficult but more important thing. Ok, that’s all for this update. If you have any questions about this car, you can come to my editor’s blog or Weibo. See you next time. (Text/map/photo by car home Fu Bo)

The Network Information Office announced the Measures for the Administration of Generative Artificial Intelligence Services; Zhang Yong: All Ali products will be connected to the big model; JD.COM ret

On April 11th, the National Internet Information Office publicly solicited opinions on the Measures for the Administration of Generative Artificial Intelligence Services (Draft for Comment) (hereinafter referred to as the Draft for Comment). The Draft for Comment consists of 21 articles, which gives detailed provisions on the generative artificial intelligence industry, including definitions, access qualifications, responsibilities and obligations, and penalties.

"The state supports independent innovation, popularization and application, and international cooperation of basic technologies such as artificial intelligence algorithms and frameworks, and encourages giving priority to the use of safe and reliable software, tools, computing and data resources. In the "Draft for Comment", the attitude of support and encouragement to the generative artificial intelligence industry was clarified.

At present, many domestic technology giants, including Baidu, Tencent, Ali, Huawei, JD.COM, 360, etc., have announced their corresponding layouts in the generative AI industry. (Source: The Paper)

With the development and application of large-scale language models and ChatGPT-like technologies accelerated by major companies, the potential risks of these artificial intelligence technologies and how to develop and apply them reasonably have attracted much attention. Thousands of top people, including Musk and stephen wozniak, the co-founder of Apple, have publicly called on AI Lab to suspend training more powerful models for six months in order to formulate and implement relevant security protocols.

According to the latest reports from foreign media, SV Angel, a top investment company, will convene executives and employees of top companies in the field of AI R&D to discuss the formulation of standards for using AI technology.

The foreign media mentioned in the report that this meeting convened by SV Angel will be held on Wednesday local time. Representatives from companies such as OpenAI, Microsoft, Google, Apple and NVIDIA are expected to attend, and the participants are expected to discuss how to continue to develop AI in the most responsible manner.

When Musk and others called for a six-month suspension of training more powerful models, they mentioned in their letters that AI labs and third-party experts should use the suspension time to jointly formulate and implement the shared security protocol for advanced AI design and development, and related protocols are strictly reviewed and supervised by third-party experts. (Source: TechWeb)

 

According to foreign media reports, TSMC, the chip foundry, recently announced its revenue in March, and the revenue in the first quarter was also released.

According to the data released by TSMC in official website, their revenue in March was NT$ 145.408 billion, down 15.4% year-on-year and 10.9% quarter-on-quarter. Revenue in the first quarter was NT$ 508.633 billion, up from NT$ 491.076 billion in the same period last year, up 3.6% year-on-year.

Although the revenue in January and February continued to grow year-on-year, which promoted TSMC’s revenue growth in the first quarter, their revenue in this quarter actually did not meet expectations.

In the first quarter financial report released on January 12, TSMC disclosed that according to the business prospects at that time, the management expected the revenue in the first quarter to be $16.7-17.5 billion. According to the conversion ratio of 1:30.7 given by TSMC in the financial report, TSMC’s revenue of NT$ 508.633 billion in the first quarter is about US$ 16.568 billion after conversion, which is lower than the expected lower limit of US$ 16.7 billion. (Source: TechWeb)

 

On April 11th, at the Alibaba Cloud Summit in 2023, Zhang Yong, Chairman and CEO of Alibaba Group, delivered a keynote speech, saying that all Alibaba products will be connected to the "Tongyi Qianwen" model in the future and be completely transformed. He believes that for the AI ? ? era, all products are worth upgrading with a big model.

"In the era of intelligence, all companies are on the same starting line. Zhang Yong said, "All industries, software and services deserve to be redone based on the new artificial intelligence technology, which will not only bring innovative customer experience, but also change our production, work and life paradigm. At the same time, he pointed out that the big model is an all-round competition of "AI+ cloud computing". The research and development of the big model with over one trillion parameters is not only an algorithm problem, but also includes the huge underlying computing power, network, big data, machine learning and many other complex and systematic projects, which need the support of ultra-large-scale AI infrastructure. (Source: The Paper)

At the management meeting on April 9th, JD.COM Retail established the latest organizational structure reform framework, which mainly included the following contents:

Cancel the business group system and change it into the business division system, and the person in charge of the original business group will be the person in charge of the business division;

Each business department under the unified management of the original business group will be divided into specific business units according to the subdivided categories, giving the category leaders more decision-making autonomy, including the rights of personnel appointment and dismissal;

In addition, in the split business unit, there will be no distinction between POP and self-operation, and the two will be fully opened and managed by a unified category manager, further realizing the "equal rights" of traffic.

This is the biggest organizational restructuring of JD.COM retail in the past five years after the business division was upgraded to a business group system in 2018. It is also the first time that JD.COM has opened up its own business and POP since it set foot in the POP business, and truly realized a plate of goods. (Source: 36Kr)

 

Recently, Li Congshan, vice president of Aauto Quicker e-commerce, has recently left. As of press time, there was no official response from Aauto Quicker.

Li Congshan has rich working experience in the field of e-commerce. He worked in Huawei and Baidu successively, and later joined Ant Group in 2017. He served as the deputy general manager of Sesame Credit and the deputy general manager of Alipay applet business unit, with the rank of P10/M5. Before joining Aauto Quicker, he served as the general manager of 1688 industrial brand business in Alibaba, responsible for the brand operation of industrial B2B e-commerce.

According to public information, after joining Aauto Quicker in 2021, Li Congshan served as the head of ecological and regional operations of e-commerce service providers. This position was very important for e-commerce in Aauto Quicker at that time. At this time, Aauto Quicker hoped to continuously enrich its service provider system, and move the cooperation support for service providers from the behind-the-scenes stage to the front stage, so as to better serve businesses and platforms through service providers. (Source: Tech Planet)

 

According to the Ministry of Industry and Information Technology, the scale of China’s computing power industry has grown rapidly in recent years, with an annual growth rate of nearly 30%, ranking second in the world. According to the statistics of the Ministry of Industry and Information Technology, by the end of last year, the total computing power in China had reached 18 billion floating-point operations per second, and the total storage power had exceeded 1,000 EB (1 trillion GB). The one-way network delay between national hub nodes has been reduced to less than 20 milliseconds, and the scale of the core computing industry has reached 1.8 trillion yuan. China Information and Communication Research Institute estimates that every input of computing power into 1 yuan will drive the economic growth of GDP from 3 to 5 years. (Source: CCTV News)

 

TheElec, a Korean electronic industry media, quoted people familiar with the matter as saying that all four models of OLED screens of Apple’s iPhone 15 series this year are expected to use M12 materials from Samsung Display Company. In addition, the new folding mobile phone that Samsung will launch later this year is also expected to use M12 material again, which is the same as last year’s Galaxy Z Fold 4 and Galaxy Z Flip 4. Samsung Display Company is also developing a new material named M13 for customers other than Apple, which may be used in Google’s folding mobile phone this year. (Source: Interface)

Recently, BYD released the new energy exclusive intelligent body control system "Yunqi". The intelligent body control system of Yunqi was developed by BYD, which also marked that BYD became the first China automobile enterprise to master the intelligent body control system independently.

Wang Chuanfu, chairman and president of BYD Group, said at the press conference that the launch of "Yunqi" is another safety technical breakthrough after BYD’s blade battery, body integrated technology (CTB) and four-motor independent drive system (Easy Sifang).

Wang Chuanfu said that the "cloud chariot" can effectively restrain the posture change of the vehicle body, greatly reduce the rollover risk of the vehicle and reduce the sitting displacement of the driver and passenger. At the same time, the cloud chariot system can effectively protect the vehicle body under complex road conditions such as snow, mud and water, avoid the collision damage of the whole vehicle caused by terrain, ensure the safety and stability of the whole vehicle, and realize the double protection of people and vehicles.

According to reports, the cloud system will be installed in BYD Dynasty series models, marine flagship models, Tengshi brand, Wangwang brand and professional personalized brand models. (Source: Geek Park)

 

On April 11th, ByteDance’s office software Feishu released a video to announce the exclusive intelligent assistant "My AI".

Different from the artificial intelligence products launched by other domestic manufacturers, from the demonstration point of view, the positioning of My AI is not like ChatGPT, which communicates with users at will, but more like Office Copy launched by Microsoft.

In the demonstration, users can generate meeting minutes through My AI summary, and create corresponding to-do items according to the meeting minutes to assist users in planning the follow-up work.

At the same time, the AI can generate reports and other content according to document data; And according to the user’s editing content, the document content can be further written, which greatly improves the work efficiency.

In addition, My AI can also help users create meetings, query case references, brainstorm, plan project progress, etc., and help users in all aspects.

It can be said that although My AI may not be as good as generative artificial intelligence that can talk freely in terms of "intelligence", at this stage, it can obviously provide more and more practical help for the work. (Source: Fast Technology)

A study in university of vermont found that TikTok content related to food and nutrition continued unhealthy food culture among young users, while the voice of experts was basically absent on the platform. Researchers advocate a shift to a weight-inclusive nutrition, and rethink the attitude of society towards body, food and health.

The research was recently published in PLOS One magazine, and found that the information of weight norms, that is, the idea that weight is the most important criterion to measure a person’s health, is dominant on TikTok, and the most popular video beautifies weight loss behavior, and takes food as the main means to achieve health and weight loss. These findings are particularly worrying in view of the existing research that shows that the use of social media by teenagers and young adults is related to abnormal diet and negative body image.

Lizzy Pope, a senior researcher, said, "Every day, what millions of teenagers and young people are taught on TikTok is very unrealistic and inaccurate in describing food, nutrition and health. TikTok, which is caught in the trend of losing weight, may be a very bad environment for the audience, especially for the main users of the platform, that is, young people. (Source: cnBeta)

Break 100 million The aesthetic love in Water Story inspires the audience’s emotional resonance.

1905 movie network news On March 26th, the fantasy love movie, which is being shown all over the country, has exceeded 100 million at the box office in China cinema. Since its release, the film has broken the box office records of many Oscar-winning films, among which the first-day box office was ranked second in the box office list of China District with 21.74 million yuan, and the first-weekend box office of Oscar-winning films in recent years was the highest with 67.5 million yuan. Since its release in North America, the film has been a hit at the box office. At present, the box office in North America has exceeded $62 million, which is the highest-grossing Oscar-winning film in North America in the past five years. At present, the global box office of the film has exceeded $170 million. In March, when many adventure action elements are killing each other, Water Story, as the only movie with the theme of love, is like a clean stream of warmth in the hearts of the audience, and it has also become the best choice for lovers to date.

As the winner of four awards, such as best film and best director, "Tale of Water Shapes" has not only enjoyed a strong box office since its release in China, but its word-of-mouth has also continued to ferment, which has been highly praised by many authoritative media, well-known directors and senior film critics in China. In addition, David and his wife, Zhou Dongyu, Jiang Shuying, Jolin Tsai, Ariel Lin, Emily, Charlie, YIN FANG and many other artists CALL for the film one after another, and the love wave formed by Water Story quickly spread in the circle of friends, Weibo and other social software.

"Tale of Water" can get a bumper harvest in three aspects: word of mouth, box office and Oscar. The most important reason is the romantic story created by director guillermo del toro in a fairy-tale way. The love between Sargam’s Eliza and the mermaid broke the audience’s inertia thinking, but across races, it restored love to its purest taste. Beautiful pictures, beautiful music and superb performances of actors are the elements that sublimate the beauty of love again. On the screen, Eliza and the mermaid embraced and guarded each other from the first contact to the last, and the experience left a deep impression on the audience. For example, Eliza and the mermaid are clasped with their fingers across the container, and there is a picture of Eliza depicting raindrops on the window. The yearning for lovers and longing for love instantly aroused many audiences’ emotional resonance. When the picture of two people communicating with picture books and making love with eggs appeared, many viewers also expressed their envy of this simple but sweeter love routine. When the mermaid finally jumped into the water with Eliza in her arms, many viewers, especially female viewers, were moved to tears at this moment.

Eliza on the screen has no lines, but she accurately presents a girl’s process from first love to passionate love with body language and micro-expression, which is inseparable from sally hawkins’s profound understanding and vivid interpretation of the role. For Eliza’s performance, director Toro once said that this is a film and role specially made for her (sally hawkins), and her temperament is unique. In addition to Eliza, Mermaid has also captivated many audiences. doug jones, his actor, paid more hardships and sacrifices for this. He spent three hours in makeup every time, staring blankly at the fish in his spare time, and finally he was "ashamed" to meet the audience. The whole set of equipment on the mermaid consumed the director Toro’s huge time and effort, and finally showed the audience this wild and elegant mermaid image on the screen.

Full of care and support is also a warm heart of Water Story. In the film, the story of Eliza, Zeldia, a black colleague, and Charles, a gay painter, holding a group to keep warm reflects Toro’s concern for marginalized people. Richard jenkins, the actor of the painter Charles, once summed up his role struggle with Zeldia with such a sentence: "In the United States in the 1960s, if you were an upright white man, it would be a great era". Three characters who were discriminated against by the secular world, Sargam Eliza, black Zeldia and gay Charles, supported their friendship with a rescue activity, and the thrills brought the audience a journey of spiritual transformation. In the film, although Charles did a lot of preparation and psychological construction to cover up his anxiety, the images exposed by nervousness when he drove past the checkpoint also made the audience worry about Eliza. When Eliza and Mermaid flooded the cinema because of playing with water, when Charles stopped the cinema manager to apologize, many viewers also praised him for his kindness. In the whole rescue process, it was Zeldia who gave the greatest support to Eliza, including her behavior of "punching in a seat" for Eliza every day at the beginning of the film, which reflected this powerful girlfriend power. Zeldia’s calmness in her actions has become Eliza’s strongest psychological backing. When the villain Richard bullied Zeldia into telling the whereabouts of the mermaid, her firm attitude and loud reprimand to her husband made the audience feel better.

As a fantasy romantic film, Water Story enhances the charm of love through poetic scenes and beautiful music. The scenes and props in the film are extremely exquisite and retro, ranging from streets and alleys, government agencies, Alisa’s rooms and cinemas to scientific research equipment, household items and clothing and shoes, which deeply restore the characteristics of the 1960s. At the same time, the film music composer Alexander Dupla adopted a lot of music from the 1930s and 1940s. With the change of the lens, the music also flowed, like a clear stream to take the audience in and out of the film. This retro picture is in line with aesthetic music, which also makes the film win the best artistic direction and the best original score in the 90th Oscar, and the audience is like being in a dreamlike journey through.


Foreign Minister of Israel: Whether the international community supports it or not, the Israeli army will continue its war with Hamas.

According to a number of media reports such as British Sky News and Qatar Al Jazeera, Israeli Foreign Minister Cohen said on the 13th that Israel will continue its war with the Palestinian Islamic Resistance Movement (Hamas) regardless of whether the international community supports it or not.
Sky News mentioned that US President Biden said on the 12th that Israel was "losing" the support of the international community because of its indiscriminate bombing of the Gaza Strip. Qatar Al Jazeera reported that Cohen said on the 13th that it would be a mistake to agree to a ceasefire in the Gaza Strip at this stage. "Whether the international community supports it or not, Israel will continue its war with Hamas". He added that "the ceasefire at this stage is a gift to the terrorist organization Hamas, which will make it come back and threaten Israeli residents".
According to the British "Guardian" report, Cohen also called on the international community to take "effective and positive" actions to protect the global waterway. The report mentioned that the Houthi armed forces in Yemen had previously warned that they would consider ships bound for or associated with Israel as "legitimate targets" in the Red Sea.
According to a number of media reports, such as the Associated Press, the United Nations General Assembly adopted a resolution on the realization of a humanitarian ceasefire in the Gaza Strip on December 12, and 153 countries voted in favour, 10 countries including Israel voted against it, and 23 countries abstained. The resolution expressed serious concern about the catastrophic humanitarian situation in the Gaza Strip and the suffering of Palestinian civilians, proposed that Palestinian and Israeli civilians must be protected in accordance with international humanitarian law, demanded an immediate humanitarian ceasefire in the Gaza Strip, immediately and unconditionally released all detainees, and ensured the smooth passage of humanitarian relief.
According to CNN and other media reports, Israeli Permanent Representative to the United Nations Eldin condemned the above-mentioned resolution as "hypocritical" on the 12th, and said that ending the conflict would only benefit Hamas. Hamas welcomed the resolution. Riad Mansour, Permanent Observer of Palestine to the United Nations, said that the UN General Assembly sent a "strong message" and that "today (12th) is of historical significance".
(Source: World Wide Web)
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Strengthen cultural self-confidence and undertake cultural mission

In Chongqing Geleshan Revolutionary Memorial Hall, the audience carefully visited and drew forward strength from the red culture; "Worry about the world first, and enjoy the world later." In front of Yueyang Tower Scenic Area in Hunan Province, thousands of tourists recited the famous work "The Story of Yueyang Tower" and got a free tour opportunity to feel the infinite charm of Chinese excellent traditional culture … The strong cultural atmosphere during the Mid-Autumn National Day holiday showed the world the spiritual outlook and cultural atmosphere of contemporary China.

习近平总书记强调:“在新的起点上继续推动文化繁荣、建设文化强国、建设中华民族现代文明,是我们在新时代新的文化使命。”文化铸魂,润物无声。有文化自信的民族,立得住、站得稳、行得远。

新时代以来,弘扬中华优秀传统文化、革命文化、社会主义先进文化,文化传承发展呈现出新的气象、开创了新的局面,中华文明更加光彩夺目,中国人民更加自信、自立、自强,文明古国阔步迈向文化强国。深入挖掘节日文化内涵,拓展内容形式,创新活动方式,人们便能在广泛参与中丰富文化体验、感悟文化精髓、坚定文化自信。

日新月异的中国,需要在互学互鉴中保持文化定力,在守正创新中激发文化活力。坚定深沉的文化自信、保持高度的文化自觉、担当起新的文化使命,奋发有为、砥砺前行,就一定能铸就中华文化新辉煌,为强国建设、民族复兴注入强大精神力量。《 人民日报 》( 2023年10月08日 01 版)

Football Summary: Messi Gods Argentina 7

On March 29th, Beijing time, let’s take a look at the latest situation of the international competition day.

Spain 0-2 away to Scotland

In the second round of Group A of the European Cup qualifiers, McTominay made two consecutive double rings. Spain lost to Scotland 0-2 away, and gave up the top position in the group after swallowing the first defeat. This 0-2 game ended Spain’s five unbeaten games against Scotland. The last time they lost to Scotland was in the preliminaries in November 1984. It has been 39 years since then, when they lost 1-2 away.

Argentina home 7-0 Cura? ao

In the international friendly match, 35-year-old Messi wore a hat at half time, Gonzalez, Enzo, Di Maria and Montiel successively made contributions, and Argentina beat Cura? ao, a weak team in Central and North America, 7-0 at home. Messi reached the milestone of the national team’s 100 goals, and the total number of goals rose to 102. Cristiano Ronaldo, the world football national team goal record holder, still has a gap of 20 goals.

Germany home 2-3 Billytime

In the international friendly match, carrasco, Lu Kaku and De Braune each scored a goal, and Belgium beat Germany 3-2. Four days ago, Belgium just beat Sweden 3-0 in the European preliminaries. On this international competition day, Belgium won two consecutive victories and scored three goals in both games.

Japan 1-2 Colombia, South Korea 1-2 Uruguay

Japan and South Korea, the two top teams in Asia, both lost 1-2. Japan was reversed by Colombia, and South Korea was beaten by Uruguay with two goals. On this international competition day, Japan, South Korea and China were all 1 draw and 1 loss. China’s opponents in the two men’s soccer matches were both New Zealand, while Japan and South Korea were Colombian and Uruguayan.