Full nomination list for the 81st Academy Awards

Topic: The 81st Academy Awards

 


Whitaker and Sid Ganis, Dean of the College of Arts and Sciences, read out the nomination list for Oscar winner.



Whitaker and Ganis, Dean of the College of Arts and Sciences, read out the nomination list for best picture in the Oscar.


  At 5: 30am local time on Thursday 22nd, and at 21: 30pm Beijing time on 22nd, Forest Whitaker and Sid Ganis, president of Academy of Motion Picture Arts and Sciences, jointly read out the nomination list for the 81st Oscar at Samuel Goldwyn Theater in Beverly Hills.


  The Curious Case of Benjamin Button, starring Brad Pitt, won the Oscar despite nothing at the Golden Globe Awards, and won 13 nominations including best film, best director and best actor. The Golden Globe best film Slumdog Millionaire was slightly defeated, with only 10 nominations, and the two will continue to compete for the Oscar for best picture. Brad Pitt will compete with phillip rourke, the Golden Globe winner. What makes people feel interesting is that following Brad Pitt’s footsteps, Angelina Jolie was nominated for Best Actress for "Changing the Son".



Phillip rourke won the Golden Globe for The Wrestler. (data map)


  It was rumored that Kawara Tsutomu the Robot was expected to be the best animated film nominated again after Beauty and the Beast. Finally, Kawara Tsutomu the Robot decided to compete with Kung Fu Panda and Lightning Dog for the best animated film Oscar.


  The list of nominations for the 81st Academy Awards is as follows:


  Best Picture (best picture)


  The The Curious Case of Benjamin Button (The), Paramount.


  Frost/Nixon, The World.


  Milk, the focus.


  The Reader, Varnstam.


  Slumdog Millionaire, Fox searchlight.


  Best director (Directing)


  Danny Bauer, Slumdog Millionaire.


  Steven Dowley, The Reader.


  David fincher, The The Curious Case of Benjamin Button.


  Ron Howard, Foster’s Dialogue with Nixon (Frost/Nixon)


  Garth Van Sant, Milk.


  Best actor (Actor in a Leading Role)


  Richard jenkins, The Visitor.


  Frank Langella, Frost/Nixon.


  Sean penn, Milk.


  Brad Pitt, The The Curious Case of Benjamin Button.


  Phillip rourke, The The Wrestler.


  Best actress (Actress in a Leading Role)


  Anne Hathaway, Rachel Getting Married.


  Angelina Jolie, Changeling the Baby.


  Melissa leo, Frozen River.


  Meryl Streep, Doubt of Child Abuse (DOBT)


  Kate Winslet, The Reader.


  Best supporting actor (Actor in a Supporting Role)


  Josh brolin, Milk.


  Robert Downey Jr., Tropic Thunder.


  Philip seymour hoffman, Doubt of Child Abuse (DOBT)


  Heath Ledger, The Dark Knight.


  Michael shannon, Revolutionary Road.


  Best supporting actress (Actress in a Supporting Role)


  Amy adams, Doubt of Child Abuse (DOBT)


  Penélope Cruz Sánchez , Vicky Cristina Barcelona.


  Viola Davis, Doubt of Child Abuse (Doubt)


  Taraji Henson, The The Curious Case of Benjamin Button.


  Melissa Tome, The The Wrestler.


  Best Animated Feature Film (animated feature film)


  Bolt, Disney Company


  Kung Fu Panda, Paramount DreamWorks


  Kawara Tsutomu the Robot (Wall-E), Disney.


  Best Foreign Language Film (foreign language film)


  The Baader Meinhof Complex (Germany)


  Entre les murs/The Class (France)


  "Embarrassment", sent to people/Okuribito, Japan


  Revenge (Revanche, Austria)


  Waltz With Bashir (Israel)


  Best score (Music Score)


  The The Curious Case of Benjamin Button (The), Paramount.


  "Resistance", Paramount looked at it.


  Milk, the focus.


  Slumdog Millionaire, Fox searchlight.


  Kawara Tsutomu the Robot (Wall-E), Disney.


  The best song (Music Song)


  Jaiho, A. R. Rahman; Slumdog Millionaire, Fox searchlight.


  Back to Earth, Peter Gabriel/Thomas Newman; Kawara Tsutomu the Robot (Wall-E), Disney.


  O Saya, A. R. Rahman; Slumdog Millionaire, Fox searchlight.


  Best original screenplay (Writing Original Screenplay)


  Dustin lance black, Milk.


  Andrew stanton, Kawara Tsutomu the Robot (Wall-E)


  Courtney hunt, Frozen River.


  Mike leigh, Happy-Go-Lucky.


  Martin mcdonagh, "Killers Don’t Have Holidays" (In Bruges)


  Best adapted screenplay (Writing Adapted Screenplay)


  Eric roth, The The Curious Case of Benjamin Button.


  John patrick shanley, Doubt of Child Abuse (DOBT)


  Peter morgan, Foster’s Dialogue with Nixon (Frost/Nixon)


  David Hare, The Reader.


  Simon beaufoy, Slumdog Millionaire.


  Best Sound Editing (sound editing)


  The Dark Knight, Warner Bros.


  Iron Man, Paramount


  Slumdog Millionaire, Fox searchlight.


  Kawara Tsutomu the Robot (Wall-E), Disney.


  Wanted, Universal


  Best Sound Mixing


  Wanted, Universal


  Kawara Tsutomu the Robot (Wall-E), Disney.


  Slumdog Millionaire, Fox searchlight.


  The The Curious Case of Benjamin Button (The).


  The Dark Knight, Warner Bros.


  Best Visual Effects (visual effects)


  The The Curious Case of Benjamin Button (The), Paramount.


  The Dark Knight, Warner Bros.


  Iron Man, Paramount


  Best Art Direction (art direction)


  Changeling the Baby, Universal.


  The The Curious Case of Benjamin Button (The), Paramount.


  The Dark Knight, Warner Bros.


  The Duchess, focus


  Revolutionary Road, Mayquez, Milla.


  Best Makeup (make up)


  The The Curious Case of Benjamin Button (The), Paramount.


  The Dark Knight, Warner Bros.


  Hellboy II: The Golden Army, Universal.


  Best photography (Cinematography y)


  Deborah Harper, Changeling the Baby.


  Claudio Miranda, The The Curious Case of Benjamin Button.


  Wiley Pfister, The Dark Knight.


  Roger deakins, Chris Mungis, The Reader.


  Anthony dod mantle, Slumdog Millionaire.


  Best Costume Design (Costume design)


  Australia, 20th Century Fox.


  The The Curious Case of Benjamin Button (The), Paramount.


  The Duchess, focus


  Milk, the focus.


  Revolutionary Road, Mayquez, Milla.


  The best editing (Film Editing)


  The The Curious Case of Benjamin Button (The), Paramount.


  The Dark Knight, Warner Bros.


  Frost/Nixon, The World.


  Milk, the focus.


  Slumdog Millionaire, Fox searchlight.


  Best live Short Film (Live Action)


  Auf der Strecke/On the Line


  Manon on the Asphalt.


  New Boy


  The Pig


  Toyland (Spielzeugland/Toyland)


  Best animated Short Film (Animated)


  《La Maison en Petits Cubes》


  《Lavatory – Lovestory》


  《Oktapodi》


  《Presto》


  《This Way Up》


  Best Documentary Feature (documentary feature)


  The Betrayal-Nerakhoon, North American distribution company to be determined.


  Adventures at the end of the world, thoughts


  The Garden, North American distribution company to be determined.


  Man on Wire, Mulan Pictures


  Trouble the Water, the spirit of the times


  Best documentary short film (Documentary Short)


  The conscience of Nhem En the conscience of nhemen


  The last inch The Final Inch


  The Witness from the Balcony of Room 306


  Smiling pinki


 

Editor: Feng Ye

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)

Exclusive interview with Wang Xiaochuan: It is a pity that sogou has not listed in China, and it is the general trend to return to A shares.

Wang Xiaochuan has made many breakthroughs in 2018. At the end of last year, sogou fulfilled his dream of 14 years and successfully listed on the NYSE; At the beginning of this year, CEO Wang Xiaochuan was elected as a new member of the Chinese People’s Political Consultative Conference for the first time.

As one of the most famous Internet entrepreneurs in China, Wang Xiaochuan has unique and profound views on the Internet. When interviewed by reporter Hu Ling in the program "Mobile Parliament Hall of the National People’s Congress and the National People’s Congress" of Phoenix. com, Wang Xiaochuan not only talked about the development of sogou and her own life, but also talked about monopoly, innovation and blockchain.

CDR is a topic that Internet bosses are most concerned about in this year’s two sessions. As a rookie in the capital market, Wang Xiaochuan was inevitably asked this topic. He said that if CDR or other means can be used, sogou is very willing to return to the domestic motherboard market.

"I am sorry that sogou has not been listed in China." As a result of IPO in US stock market, users and investors in sogou split into two groups. Because users should be the group that understands products best and makes more effective investment decisions, their attention to sogou can also amplify the brand ability of products. On the contrary, when new products are released, investors in sogou will become users in sogou. As long as such an internet company can succeed, it will grow very fast, and at the same time it will bring a positive cycle: investors can share the growth benefits of the company simultaneously.

Now listed overseas, investors and users are separated, and the product lacks a channel to penetrate into users.

"So I think it is the general trend to be able to return to A shares. This national policy has solved our other mechanism problems. I think it is a very good thing for our company, for the whole Internet company, and even for the whole enterprise that can serve the public." Wang Xiaochuan said.

As for how to return to A-shares, he believes that we should still follow the direction encouraged by the state. He said, "The opening of CDR is the best way to solve the problem with the least change."

This is a giant era. In recent years, BAT has been actively deployed in almost every innovation field. As Ma Yun, Ma Huateng and Ma Dongmin are the chairmen of Alibaba and Tencent and the major shareholders of Baidu respectively, some people jokingly said that the Internet in China is going to be named Ma.

Although the giants seem to be in control of the fate of all enterprises, Wang Xiaochuan is still optimistic about the development of the Internet. He feels that if the development of science and technology industry is viewed in a longer time dimension, the pace of innovation will not stop. It’s like the birth of Microsoft broke the monopoly of IBM, followed by Google, which seemed to dominate the world, and Facebook was killed halfway.

His other reason is that the Internet may gradually penetrate into many national economies and people’s livelihood in the future, and there will be no Internet companies in the future. "In 2007 and 2008, Sohu will also set up a mobile business unit; But now if a company has a mobile division, it is finished. "

Even today’s two "horses", they have not inhibited innovation. Innovation is still emerging, just like Meituan before and bike-sharing now. These emerging companies are also willing to form alliances with giants to help them develop faster.

Therefore, Wang Xiaochuan’s point of view is: "In this era, if everyone really wants to use the word monopoly, monopoly is not eternal."

In addition, monopoly does not necessarily bring global harm. Taking the relationship between Tencent and sogou as an example, Wang Xiaochuan explained that Tencent finally realized that Tencent’s search was not as good as that of sogou, and gave all the search teams to sogou. Now the Chengdu branch in sogou is a branch of Tencent.

Every stage of Internet development seems to be accompanied by a bubble. In the past two years, everyone was still worried about whether there were too many bubbles in artificial intelligence. This year, the fanaticism of blockchain made more people stunned.

The bubble of artificial intelligence is different. A few times ago, the so-called artificial intelligence era came, and as a result, there was nothing after the ebb tide. Now artificial intelligence has reached a new stage, and the current capital inflow belongs to "capital began to enter, and the money invested today is 100 times and 1000 times higher than before." When we settle down, you find that it is rewarding, which has changed life. "    

However, the bubble of blockchain means cost for ordinary people. "It is best for Bitcoin to have an access mechanism because the risks are higher." When it comes to blockchain, Wang Xiaochuan is worried. "Only in this way can we encourage and protect more innovation."

The popularity of blockchain is rising so fast that even Wang Xiaochuan is worried about falling behind, and this worry is still very strong. Some time ago, a friend who was studying biology came to ask him about the blockchain. As a result, this friend studied more deeply than his computer major. Wang Xiaochuan said that it was impossible, so he quickly made up for it himself. From technology to business and political events inside, he finally understood the blockchain.

"Blockchain is a decentralized and highly anarchic thing. In political practice, it has its own problems. If it is not careful, it will be centralized, or if it is not centralized, it will be inefficient. We are concerned about how it can establish a certain central influence. " Now Wang Xiaochuan has been able to talk about this topic Kan Kan, and completely found his own feelings.

In order to stay behind, Wang Xiaochuan began to play the glory of the king these days. Because he found that many articles will mention some of the terms, and now he can’t read the articles without playing games. However, because there is no special time to play, his level is really bad.

In addition to worrying about falling behind, Wang Xiaochuan also has some other anxieties. For example, he wants to go back to the company to reach a consensus on his business now. This science and technology man rarely shows a little literary cell: "The plan for one year lies in spring, and now spring is almost over."    

Looking back over the past ten years, there may be some things that could have been done better, but now, after all, we can’t go back to the past, so Wang Xiaochuan has nothing to regret, only that he has experienced setbacks and failures and gained various experiences. When the company didn’t go public, the only indicator that the outside world looked at sogou was the market share of search. Now the CEO has really lost some burdens and started to talk about his ambitions for the future — — Make something cool.

How to understand cool things? For example, the translation machine introduced by sogou some time ago can solve the problem of information exchange, which is cool in his view. What sogou wants to do is not another Google or Baidu, but something of its own combined with the reality of China, and its investment and strategy have to be upgraded.

In addition to Sogou CEO, Wang Xiaochuan has another famous title, that is, the bachelor in the Internet business. In an interview with Hu Li, Wang Xiaochuan rarely responded to this topic.

He said that he is not looking for a girlfriend, and personal problems will be slowly put on the agenda. However, when it comes to this relatively romantic thing, he still showed his nerd thinking: "But there is a good thing. Today, due to the highly developed biotechnology, people can have a longer protection time, so they can have some comfort for themselves."

China’s vaccine supply has steadily increased, and COVID-19’s vaccination has accelerated again.

CCTV News:With the steady increase of vaccine supply in China, vaccination in COVID-19 has been accelerated again.

Since China started the vaccination work in COVID-19, all localities have strengthened the connection between vaccine supply and demand, and the vaccination system has operated efficiently. Nan ‘an District of Chongqing has established a vaccine distribution guarantee system, set up three optimal distribution routes, and dynamically balanced the progress of each inoculation site to ensure that the total inventory of the whole district is cleared in time.

Li Liu, Deputy Director of Nan ‘an District Health and Wellness Committee:At present, 40% of the permanent population in the whole region has been vaccinated, and the key population has achieved all the answers.

Nangong City, Xingtai City, Hebei Province divides the whole city into 16 urban grids and 15 township grids, and takes the initiative to vaccinate people with mobility difficulties, so as to ensure that everyone should be connected. Liaison officers in every county in Hubei Province are online 24 hours a day to pay attention to the distribution of vaccines in real time. Recently, 15 inoculation points in Yichang City have been put into use one after another, and the number of inoculation points in the city has increased from 53 to 140.

Jiang Jing, Deputy Director of Institute of Immunoprevention, Yichang CDC, Hubei Province:The daily inoculation amount has increased from the previous 17,600 doses to nearly 100,000 doses.

Various ways have also been adopted to encourage the public to actively vaccinate. Harbin City, Heilongjiang Province posted a "Little Blue Sticker" to the 100% vaccinated business merchants, so that the citizens who come to consume can see at a glance and know fairly well. Shandong province has decided to implement the responsibility system of residence for cross-regional vaccination, and it is not allowed to refuse to provide vaccination services because the household registration is not local. Shandong has also upgraded the health code, and the health code will be changed from green code to gold code after vaccination.

Li Di, a citizen of Jining City, Shandong Province:I think it’s very interesting, so I also came here to get the COVID-19 vaccine today, and I also want to put my green health code in Phnom Penh.

Don’t get me wrong about these English (8)

Eminem, an American rapper, brought the film to perfection in the last part of his semi-autobiographical film "Eight Miles". Jimmy, who he played, won the championship in the impromptu rap contest in Detroit’s black area. When all the rappers waved their arms up and down with the music, you might feel excited. Many rappers saw this part and strengthened their belief in making Chinese rap music, but this English that made the audience high was easily misunderstood as other meanings.

1. bring down the house.

Get a house full of applause, not knock down the house.

Don't get me wrong about these English (8)

2. have a fit.

Lose one’s temper, fly into a rage, not trying on clothes

Don't get me wrong about these English (8)

3. make one’s hair stand on end.

It’s creepy, not outrageous.

Don't get me wrong about these English (8)

4. be taken in.

Deceived, not accepted.

Don't get me wrong about these English (8)

5. pull up one’s socks.

Courage, not socks.

Don't get me wrong about these English (8)

In a blink of an eye, 2013 is over half. How is your dream coming true? Courage to pursue your dream can be not only someone else’s business, but also your business. I also wish you pull up your socks and chase your dream. See you next week!

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Don’t get me wrong about these English (7)

Don’t get me wrong about these English (6)

Don’t get me wrong about these English (5)

Don’t get me wrong about these English (4)

Don’t get me wrong about these English (3)

Don’t get me wrong about these English (2)

Don’t get me wrong about these English meanings (1)

About the author:

Don't get me wrong about these English (8)

Leon, graduated from Harbin Institute of Technology, is a bilingual psychotherapist. Former editor-in-chief, good at American English, friends ashes powder, hobby HipHop and raising dogs. Now I live in Beijing and have my own psychological studio.

(Editor of China Daily English Dianjin Julie)

Development and Reform Commission investigates the monopoly of the shortage drug raw material drug market, and the price of some drugs has soared exponentially.

  CCTV News:In recent years, the National Development and Reform Commission found that some APIs, minority drugs and cheap drugs have become the frequent areas of price monopoly violations. Let’s take a look at two cases investigated before.

  A monopoly case that occurred from April 2014 to September 2015, allopurinol tablets, as a commonly used drug for treating gout, were listed in the national list of essential drugs and the national list of low-priced drugs, with low prices. However, around 2015, the price of each bottle has soared from 10 yuan to more than 30 yuan, and it is even difficult to buy.

  The relevant person in charge of the National Development and Reform Commission told the reporter that this is a typical case in which a shortage drug raw material drug manufacturer implements monopoly. The involved enterprise Chongqing Qingyang Pharmaceutical Co., Ltd. and its affiliated sales company Chongqing Datong Pharmaceutical Co., Ltd. and other five companies negotiated to divide the sales market and uniformly raise the price of allopurinol tablets, resulting in high prices of downstream drugs and tight supply.

  Isoniazid, as a raw material drug for treating pulmonary tuberculosis, has been monopolized by Zhejiang Xinsecco and Tianjin Handewei, which makes the price rise abnormally. In 2013 and 2014, the price of raw material drug of isoniazid was between 150 yuan/kg and 200 yuan/kg, which rose sharply in less than two years, and even rose to 3,800 yuan/kg in some batches, and the price of raw material drug obtained by some pharmaceutical companies from distributors was even higher.

  Wang Yanglin, Anti-monopoly Division II of the Anti-monopoly Bureau of the National Development and Reform Commission, said that there are actually many reasons for the shortage of medicines, and there are indeed fewer manufacturers. Because of the shortage and easy to be controlled by some illegal people, the prices of these drugs have skyrocketed.

  The anti-monopoly department of the National Development and Reform Commission has successively investigated and dealt with a number of price monopoly behaviors carried out by operators of short-selling drugs and APIs. Up to now, the investigation and handling of price monopoly cases of short-selling drugs and APIs has covered more than ten provinces and cities such as Shandong, Chongqing and Hubei, and the APIs involved include allopurinol, isoniazid and other varieties, with a total economic sanction of about 16.13 million yuan.

  Xu Xinyu, director of the Anti-monopoly Division II of the Anti-monopoly Bureau of the National Development and Reform Commission, said that in fact, the goal of anti-monopoly law enforcement is not to promote price reduction or price increase, but to restore this business order. We believe that there is a healthy mutual competition, and its price level must reflect market supply and demand, and prices will return reasonably.

Corrupt officials were found to be involved in nearly 300 million cases after retiring for 8 years.

       CCTV News:On December 29th, 2017, the website of the Supervision Department of the Central Commission for Discipline Inspection reported eight typical cases that violated the spirit of the eight central regulations. Among them, Liu Beixian, the former Party secretary and president of China News Agency of the State Council Overseas Chinese Affairs Office, flew in first class for many times on official business trips from 2013 to 2014, and held a daughter’s wedding banquet in violation of regulations. At the same time, he still has other serious violations of discipline, and he was expelled from the party and his retirement benefits were cancelled. As can be seen from the published resume of Liu Beixian, he retired in February 2015.

       I have been retired for more than two years and can I still be filed for review? Such a case is not a case.

       Zhao Shaolin, former member of the Standing Committee of Jiangsu Provincial Party Committee, retired for 8 years and was investigated for nearly 300 million cases.

       On the morning of May 18th, 2017, Zhao Shaolin, former member of the Standing Committee of Jiangsu Provincial Party Committee and Secretary-General, issued a verdict on bribery and fraudulent purchase of foreign exchange. This big tiger, who fell off his horse after eight years of retirement, was finally sentenced to four years in prison and fined 15 million. The court said that Zhao Shaolin not only voluntarily confessed the facts of the crime, actively cooperated with the recovery of the money and materials involved, but also reported other people’s major crimes, which was a major meritorious service.

       It was found through trial that from 2007 to 2014, the defendant Zhao Shaolin, while serving as the general counsel of the company actually controlled by his son Zhao Jin, together with Zhao Jin, asked others to help his company illegally operate real estate projects and paid bribes worth RMB 4,448,950. Zhao Jin was helped to defraud the relevant authorities of the examination and approval documents by forging foreign trade contracts and paying fees abroad, which was used to fraudulently purchase foreign exchange and remit it abroad, totaling more than 41.7 million US dollars, about 287 million yuan.

Zhao Shaolin is on trial.

Zhao Shaolin is on trial.

       He Baolin, former deputy director of the People’s Social Security Bureau of Baoji City, Shaanxi Province: "You can help the poor after retirement."

       Compared with Zhao Shaolin’s behavior, there is another way of corruption related to retirement, which is hidden and difficult to be found, but it is very harmful, so we must be vigilant. That is option corruption. The so-called option corruption refers to the fact that leading cadres use their power to seek benefits for others when they are in office, but they don’t want to "return" immediately, but they only cash in "rewards" in various forms after leaving or retiring according to private "agreements". It is similar to futures trading, in essence, corrupt officials avoid "direct" trading of power and money and try to escape the punishment of party discipline and state law.

       He Baolin, the former deputy director of the Human Resources and Social Security Bureau of Baoji City, Shaanxi Province, who was over 60 years old, used his power to "greet" two hospitals in the examination and approval of medical insurance and recovery, and was sentenced to 10 years in prison for accepting bribes. According to the confession of the briber, He Baolin refused and returned the bribe, and verbally agreed with the briber: "It is not appropriate to collect money now, and you can help the poor after retirement." This is a typical option corruption.

one

       "I have helped this boss a lot. When he wants to thank me, I told him that there is no shortage of money now. You can spend some time and play for me after I retire. Later, he gave me a bank card of 3.4 million yuan. " Fan Jianguo, the former chairman of Suizhou CPPCC in Hubei Province, who was sentenced to life imprisonment for accepting bribes, fully exposed the nature of corrupt officials who "can’t afford to be early without benefits".

       As a "variant" of corruption, option corruption is more hidden and harmful than the instant power and money transaction of "you give me money to do things".

       Some corrupt elements also regard it as a brilliant move: engaging in option corruption can not only ensure that the profits will not fail, but also "act according to the system" and avoid naked transactions, so as not to fall behind "handles". Even if others suspect, the benefits will not be "cashed" until a few years or more after leading cadres leave their jobs or retire, and the difficulty of obtaining evidence and verifying them will also increase.

       Some leading cadres, after retirement, go to the enterprises that they have "helped" as executives, and get the high "salary" agreed in advance, while others directly reach out and ask for the agreed "income". Li Yongheng, the former director of Guangdong State Taxation Bureau, asked the enterprises he had cared for for for cash, real estate and other property worth nearly 9 million yuan in less than a year.

       Experts say that option corruption mostly breeds in key economic fields such as land use right transfer, project bidding, property right transaction and government procurement. Once it happens, it will definitely cause great losses to state property.

       Jiang Weijun, former deputy inspector of Jilin Provincial Department of Commerce, was suspected of serious violation of discipline and accepted organizational review.

       On January 11th, 2018, the website of CPC Central Commission for Discipline Inspection Supervision released a message: With the approval of Jilin Provincial Party Committee, Jiang Weijun, the former deputy inspector of Jilin Provincial Department of Commerce, was suspected of serious violation of discipline, and is currently under organizational review.

       Through the published resume of Jiang Weijun, his post before retirement is in line with the expert’s analysis of the fields prone to option corruption: in September 1994, he served as deputy director of the Foreign Economic and Trade Department of Jilin Provincial Economic and Trade Commission; In August 2000, he served as Director of the Trade Market Division of Jilin Provincial Economic and Trade Commission; In June 2004, he served as Director of the Import and Export Department of Mechanical and Electrical Products of Jilin Provincial Department of Commerce; In March 2009, he served as director of the mechanical and electrical products import and export department of Jilin Provincial Department of Commerce (provincial mechanical and electrical products import and export office); In January 2016, he served as chief economist of Jilin Provincial Department of Commerce; In February 2017, he served as deputy inspector of the Jilin Provincial Department of Commerce; Retired in September 2017.

       Zhuang Deshui, deputy director of Peking University Research Center for Clean Government Construction, believes that the characteristics of option corruption should be regulated from the system. For example, according to the administrative level and power characteristics of different officials, the fields of employment of officials after resignation and retirement should be clarified, so that officials can exert their residual heat without showing off their arrogance.

one

       Governments at all levels should change their functions, simplify administration and decentralize power, fully publish the list of powers and responsibilities of local governments, so that "there is no power outside the list, but there must be something inside the list", put a "tight hoop" on power, give full play to the role of the market in resource allocation, break the "hidden rules" of corruption and rent-seeking, prevent power from entering the market, and eliminate the breeding ground of power "futures trading".

       The French open is long and sparse, but it does not leak. As long as you use the power in your hands to gain illegal gains, no matter how the tricks are refurbished or how the behavior is hidden, you are doomed to escape from the "hand of justice" of party discipline and state law. Since the 19th National Congress of the Communist Party of China, China has never stopped and relaxed its efforts to crack down on corruption. In this high-pressure situation, you are advised not to stretch out your hand, and you will be caught if you stretch out your hand! (Text/Liu Shan)

China’s economic development is full of stamina and keeps moving forward.

       CCTV News:Today (October 27th), News NetworkBroadcast a reportA number of data in China’s economic field have been published. Key words such as "growth" and "high level" have highlighted the overall development trend of China’s economy, and at the same time, other fields have also frequently achieved good results. The "big ship" of China’s economy will surely ride the wind and waves and continue to move forward.

In the third quarter, the profits of industrial enterprises nationwide increased by 7.7% year-on-year.

According to the data released by the National Bureau of Statistics today (October 27th), since the beginning of this year, with the continuous improvement of market demand and the steady growth of industrial production, the revenue and profits of industrial enterprises have continued to improve. Among them, the profits of industrial enterprises above designated size increased by 7.7% year-on-year in the third quarter, and the profits of industrial enterprises showed an accelerated recovery trend. On a monthly basis, in September, the profits of industrial enterprises above designated size increased by 11.9% year-on-year, achieving double-digit growth for two consecutive months.

The revenue of industrial enterprises has obviously improved. In the first three quarters, the operating income of industrial enterprises above designated size nationwide reached 96.35 trillion yuan, which was the same as that of the same period last year, and the growth rate was faster than that of the first half and the first quarter.

       In the third quarter, the profit of manufacturing industry increased by 11.8% year-on-year, of which the profit of raw material manufacturing industry increased by 60.8% year-on-year and the profit of consumer goods manufacturing industry increased by 11.8% year-on-year.

In the first three quarters, the investment scale of transportation fixed assets remained high.

According to the latest data released by the Ministry of Transport, in the first three quarters, China’s transportation fixed assets investment reached 2,877.5 billion yuan, a year-on-year increase of 5.6%, and the scale of transportation fixed assets investment remained high. Port cargo throughput also maintained rapid growth in the first three quarters. 1— In September, the total cargo throughput of ports nationwide was 12.54 billion tons, up 8.5% year-on-year, of which the foreign trade cargo throughput was 3.77 billion tons, up 10.1% year-on-year. Container throughput reached 230 million TEUs, up 5.2% year-on-year.

Data sorting out the achievements of the 134th Canton Fair.

The second phase of the 134th Canton Fair ended today (October 27th). Up to now, this year’s Canton Fair has carried out 53 "Bridge of Trade" global trade docking activities, attracting more than 220 buyers and more than 620 suppliers for "one-on-one" docking negotiations, with an intended purchase amount of about 100 million US dollars. Since the opening ceremony, more than 157,000 overseas buyers from 215 countries and regions have attended the meeting, an increase of 53.6% over the same period last year. Among them, there are more than 100,000 buyers in the "Belt and Road" countries, accounting for about 64%.

The third phase of the Canton Fair will be held from October 31st to November 4th, with more than 11,000 enterprises participating offline. The exhibition is divided into five sections: toys and pregnant babies, fashion, household textiles, stationery and health and leisure.

In October in Yangcheng, all merchants gather. In Guangzhou these days, not only is the booth crowded, but many hotels in the city are also hard to find a room. Against the background of sluggish demand in the world economy, such a scene is very emotional. The bustling passenger flow is people’s confidence in China’s economy.

The 24th Central China Agricultural Expo opened.

       The 24th Central China Agricultural Expo opened today in Changsha, Hunan. This year’s Expo set up special exhibition halls such as the Central Inter-provincial Pavilion and the Agricultural Service Pavilion, which attracted nearly 5,000 enterprises to focus on the exhibition and sale of high-quality agricultural products. During the exhibition, China Central Agricultural Brand Promotion Conference and other activities will be held.

The latest scientific and technological achievements of start-up technology enterprises are concentrated in appearance.

Recently, the 17th Innovation China was held in Beijing Shougang Park. Nearly 100 outstanding start-up technology enterprises from all over the country brought their latest scientific and technological achievements to the show. Focusing on the theme of artificial intelligence, this activity covers intelligent manufacturing, life sciences, new energy and green economy, intelligent interconnection and new businesses. Since the launch of the activity in 2006, more than 1000 investors have been gathered to connect with entrepreneurs on the spot to help the entrepreneurial team grow rapidly.

In the third quarter, civil aviation completed 180 million passenger trips.

In the third quarter, China’s civil aviation maintained a safe and orderly recovery trend, and transportation production continued to improve. The total transportation turnover of the whole industry was 33.68 billion tons kilometers, an increase of 89.3% year-on-year; There is a strong demand in the passenger transport market. The whole industry has completed a total of 180 million passenger trips, up 108.3% year-on-year, and the passenger transport scale of the industry has reached a quarterly record high.

This year, China’s digital supply chain market will exceed 32 trillion.

The relevant person in charge of China Federation of Logistics and Purchasing introduced at the 6th Digital Supply Chain Platform Development Conference today (October 27th) that China’s economy is recovering continuously and its growth momentum has been enhanced. Under the background of accelerating the reconstruction of the global industrial chain supply chain, the development of China’s digital supply chain platform has entered the fast lane.

According to the relevant person in charge of China Federation of Logistics and Purchasing, it is estimated that as the largest manufacturing and consumer market in the world, the market size of China’s digital supply chain will increase from 8.25 trillion yuan in 2018 to 27.2 trillion yuan in 2022, with a compound annual growth rate of 26.94%. In 2023, the market size of digital supply chain will exceed 32 trillion yuan. The security and stability of the supply chain provides strong support for smooth double circulation, promoting high-quality economic development and enhancing international competitiveness.

China has boosted the global mining market to stabilize and recover.

The Global Mining Development Report 2023 shows that China’s economy has recovered rapidly, and the demand for mineral resources has remained high, effectively stimulating the global consumption demand for energy resources.

       According to the latest data, in 2022, with the global demand for mineral resources shrinking, China’s energy and mineral resources remained stable and its consumption continued to grow, which played an important role in stabilizing the global mining market. For example, in 2022, China’s coal consumption reached 3.041 billion tons, a year-on-year increase of 4.3%. The domestic coal production capacity was released steadily, and the coal mine operating rate remained high, with the annual output reaching 4.496 billion tons, up 9% year-on-year.

In the first three quarters, residents spent a total of 3.69 trillion yuan on domestic trips.

       The Ministry of Culture and Tourism released the data of domestic tourism in the first three quarters of 2023 today (October 27). According to the statistical results of domestic tourism sampling survey, the total number of domestic tourists in the first three quarters of this year was 3.674 billion, an increase of 1.58 billion over the same period of last year and a year-on-year increase of 75.5%. In the first three quarters, residents spent 3.69 trillion yuan on domestic trips, an increase of 1.97 trillion yuan or 114.4% over the previous year.

Ministry of Commerce: I am confident to achieve the goal of promoting stability and improving quality of foreign trade throughout the year.

On October 26th, the Ministry of Commerce held a regular press conference. The spokesman said that China’s foreign trade is running smoothly on the whole, and it is confident to achieve the goal of promoting stability and improving quality of foreign trade throughout the year.

The Ministry of Commerce said that since the beginning of this year, due to high inflation, high inventory and geopolitical risks, global trade has continued to be weak. According to the data of the World Trade Organization (WTO), global exports fell by 4.6% in the first half of the year. Based on concerns about growth difficulties and challenges, the WTO recently lowered the growth rate of global merchandise trade in 2023 from the previous forecast of 1.7% to 0.8%.

In the face of multiple risk challenges, China has solidly promoted the policy of stabilizing foreign trade, and China’s foreign trade has generally operated smoothly, especially in recent months.

Shu Yuting, spokesperson of the Ministry of Commerce:In terms of scale, China’s import and export scale rose quarter by quarter, and increased month by month in the third quarter. In September, the import and export volume reached a single-month high in the year. In terms of share, WTO data show that China’s export international market share reached 14.2% in the first half of the year, 0.4 percentage points higher than the same period last year.

From the main point of view, the number of foreign trade enterprises with import and export performance in the first three quarters was 597 thousand, which was close to the level of last year. From the perspective of kinetic energy, superior products such as automobiles, ships, lithium batteries and luggage maintained a relatively high growth rate, and new cross-border e-commerce formats continued to contribute to the increase.

Shu Yuting, spokesperson of the Ministry of Commerce:These positive changes are inseparable from the persistence and innovation of the majority of foreign trade subjects, the effective implementation of stable foreign trade policies, and the resilience and vitality of China’s foreign trade. With the continuous accumulation of positive factors, we are confident that we will continue to consolidate the good operation situation in the fourth quarter and we are confident that we will achieve the goal of promoting stability and improving quality of foreign trade throughout the year.

In addition, recently, the National Data Bureau was established. The newly established National Data Bureau is responsible for coordinating and promoting the construction of data infrastructure, coordinating the integration, sharing, development and utilization of data resources, and coordinating the planning and construction of digital China, digital economy and digital society. 

Celebrate Nurses’ Day in various forms around the country and pay tribute to angels in white.

CCTV News:Today (May 12th) is the International Nurses’ Day, and the theme of this year’s Nurses’ Day in China is "developing nurses and improving nursing services". Over the past few days, various places have held colorful activities to celebrate the Nurses’ Day and pay tribute to angels in white.

On the eve of the 112th International Nurses’ Day, Chengdu Railway Health School held a ceremony of "passing light and awarding hats" for more than 1,600 graduates who are about to take up nursing posts. In melodious music, seniors put on holy swallow hats for nursing graduates, lit candles in their hands, and held lanterns for the goddess — — Nightingale’s spirit of "burning herself and illuminating others" was passed on to a new generation of nurses.

Xu Che, Class 6, Class 2021, Chengdu Railway Health School:Respecting life and ensuring health is a promise that every medical staff should abide by. In my future work, I will treat every patient with sincerity, love and responsibility.

With the development of society, in recent years, more and more male nurses have joined the nursing team. By the end of 2021, among the more than 5 million nurses in China, the proportion of male nurses accounted for 3%. In the celebration of Nurses’ Day held by the First People’s Hospital of Huai ‘an City, Jiangsu Province, male nurses showed their daily work and elegance through adapted songs and dances.

Xu Keping, Party Secretary of Huai ‘an First People’s Hospital:Male nurses in some special nursing positions, especially in critical care, operating room, ICU and other positions, need not only the rapid response of nursing itself, but also some physical strength sometimes, and male nurses show their superiority in this respect.

In order to improve the level of nursing service, on the eve of Nurses’ Day, Fudan Zhongshan Xiamen Hospital held a nurse skills competition. First of all, the discussion is intravenous indwelling needle puncture, which requires the contestants to choose the best puncture site of vein for puncture and fix it properly. Then the competition is first aid skills, nurses need to judge the patient’s condition, carry out cardiopulmonary resuscitation in time, and cooperate with the use of defibrillator.

Yan Meiqiong, Executive Director of Nursing Department of Fudan Zhongshan Xiamen Hospital:The skills of various specialties and first aid skills have very high requirements for nurses. Through such skill operation training, the nursing technical operation level of hospital nurses is continuously improved, professional knowledge is updated, nursing quality is improved and nursing safety is guaranteed.

ByteDance’s boss culture: honesty

Image source Tuchong creativity

Editor’s Note: This article is from the steering boat, written by Li Yanglin, and reproduced by the entrepreneurial state with authorization.

It is difficult for startups to escape the word "boss culture". Corporate culture reflects the boss’s style to some extent.

Before starting to study Zhang Yiming/Byte, the steering boat tried to get to know the company with Byte employees. Many people say that this company has a strong brand of Zhang Yiming and a boss culture. From system to process, Zhang Yiming’s thought has been well implemented.

So, what exactly is Zhang Yiming’s style?

These two words are obvious: honesty.

Many entrepreneurs in China are fans of Jack Welch, former CEO of General Electric (GE) Group, and so is Zhang Yiming. If Drucker helped Zhang Yiming deepen his understanding of "courage", then Jack Welch helped Zhang Yiming deepen his understanding of "frankness".

The frankness mentioned here does not mean that you can vent your emotions without scruple or make malicious subjective life attacks. Emotion and fact are two different things. “Emotion "hurts self and others, and" facts "can help self and others grow.

The frankness mentioned here means that under the premise of achieving the goal and solving the problem, everyone can put down their guard and communicate without consideration, express their views and put forward constructive suggestions. Lack of frankness will fundamentally stifle keen creativity, hinder quick action and prevent outstanding people from contributing all their talents.

Unfortunately, it is a common cognition of human beings to take good care of the scene and not be too frank. Because it can protect yourself well. Being too frank will lead to trouble. From childhood, we began to learn how to cover up bad news and make everything look good.

This social culture of "hello, I am good, everyone is good" has also been brought into commercial companies.

For example, we promote a project in the company, and the effect is not bad, but there is still a lot of space to iterate. Without iteration, the project will have no future.

But what are we often talking about when we hold project meetings?

It’s really not bad, we did our best, it was really excellent, I like you and so on. The impression left after the meeting was "We are not bad".

But everyone knows in their hearts that if this is the case, the future is extremely slim. How fierce the competition is outside.

Although everyone is very uneasy, they would rather feel better for everyone’s face, and even choose to give up exploring the future.This is what happens every day in many companies.

Zhang Yiming said that "dishonesty" in business life is actually a selfish performance. In order to make your own life and work easier, this kind of thinking is often short-sighted, and this lack of foresight may be rooted in cowardice.

People who dare to get angry and speak out directly will be regarded as heterogeneous at the beginning and labeled as "low emotional intelligence" The young Jack Welch, was also so warned:

From the day I joined GE until I was appointed as CEO, for 20 years, my bosses often warned me not to be too straightforward. I am classified as rude, and I am always warned that being too blunt will soon hinder my career.

Fortunately, although people are afraid of embarrassment, they prefer truth. Welch’s later achievements are a good illustration. When you present a frank, pragmatic and efficient work style, you will attract people with the same characteristics to join. Generally speaking, such a team is more likely to create good performance than a team that is not honest, pragmatic and efficient.

In addition to Welch’s inspiration, Zhang Yiming also has his own understanding of "frankness". He said: "In this society where information flows faster and more transparent, from an economic point of view, the cost of being a duplicitous person is getting higher and higher, and dirty people will get more and more unlucky. Not pretending to be improper is a moral character preference, and it is also more economical. Many people have not realized this. "

He praised this sentence: it is good to be honest and ruthless in communication, and this does not prevent you from being a warm, humorous and constructive person. But honesty is extremely important for people who work together.

In addition to dishonesty, there is also a kind of dishonesty that is hidden deeply, which is called "self-satisfaction".

The resistance to self-satisfaction is the culture of bytes. Zhang Yiming said: "I have always felt that deliberately touching others is almost cheating."

If you are moved by this, even yourself, you are deceiving yourself.

Now, Zhang Yiming has brought "honesty" into ByteDance.

Regarding how ByteDance landed a "frank" boss culture, the steering boat combed several details:

First: OKR

ByteDance implements bimonthly OKR, so that everyone can check other people’s OKR details, so as to better coordinate. Zhang Yiming’s own OKR is also open. Byers can learn what bosses are busy with recently, which can actually play a comparative role and know their own direction of efforts and whether it is important in the company.

In contrast, departments in many companies don’t know what each other is doing. To make matters worse, in a department, no one knows what each other is busy with.

Second: information is "urgent"

We often encounter things that don’t return information at work, which you think is very important, but the collaborators don’t understand it that way. This kind of gap makes the workplace full of infinite waiting.

I once encountered such a situation. The middle managers of a company talked about the fact that the president didn’t reply to the information behind his back, but they were afraid to communicate face to face, which led to many things not being promoted.

So what will Bytes do? Through collaboration software’s work, the information is expedited, and the other party is forced to push it, and the other party is strongly required to reply to the information. Regardless of whether the other party feels uncomfortable.

Third: strong "pull the group"

What if the other party doesn’t reply to the message if it is urgent? Then byte can find the other person’s boss to promote the work without caring about the other person’s feelings. What if the boss doesn’t reply to the message? Just pull the boss’s boss, if not, pull the boss’s boss, and you can pull it all the way to Zhang Yiming.

Byte culture, so that everyone has no psychological burden to do so. Everything is not to vent emotions, but to solve problems.

Fourth: Score each other.

How is your work done? Bytes are evaluated 360 degrees every six months. Your collaborator will grade your real name. What about you? The eyes of the masses are discerning.

Scoring each other may bring the phenomenon of being a good guy, or someone maliciously scores low. Fortunately, it is a real name. If there is an impersonal nice guy, he will be communicated, and if there is a malicious low score, he will also be communicated.

How do you grade, the eyes of the masses are also discerning.

Jack Welch said that for some people, becoming a leader means starting their own journey of power. They like the feeling of keeping control over people and information, so they will keep secrets, keep their thoughts on employees and their performance secret, and hide their thoughts on the future development of the company. This behavior allows the leader to establish his own territory, but he excludes trust from the team.

Trust appears when leaders show sincerity, frankness and keep their words. When you always cover up or whitewash those bad information, you may lose the trust and support of the team.

I hope I can be liked by everyone, which will make a manager insomnia and headache. Because you have to make a firm decision, let unqualified employees be laid off and let inappropriate projects be closed.

Obviously, excessively tough demands will lead to complaints and resistance from others. But as Welch said: On the basis of fully listening to opinions and explaining your ideas clearly, you must move forward, don’t hesitate, and don’t cheat and cajole. If you are honest-although you can never be absolutely honest-you will find that everything will work faster and better.

Zhang Yiming is practicing this rule.

Bytes may rarely come into contact with Zhang Yiming, but they all know:

I can say no to Zhang Yiming.

I booked this conference room in advance, even if Zhang Yiming came to jump the queue, he shouldn’t let me.

As far as Zhang Yiming is unprofessional, we can ask him to shut up.

This is the best sense of security for employees.

Steering boat recommends "frankness" in this article, not to praise how great ByteDance is, but to hope that entrepreneurs and managers who read this article can realize that you have better means to solve problems: when you feel communication difficulties, the best communication method is not to think too much about skills and arguments, but to communicate more frankly.

When you feel that management is very difficult, you can realize that frank communication is the main problem of company team management.

Honest corporate culture can be learned. Welch’s methodology is: to popularize the spirit of frankness, you must inspire it, appreciate it and talk about it all the time. You can make people who show honesty into heroes of the masses. The most important thing is that you have to be energetic yourself, and even exaggerate this spirit and prove it to everyone.

However, we also need to be psychologically prepared, and it is extremely difficult to do things right and against humanity with the whole human secular culture, although it is very rewarding.

How to break through? Grasping the team means grasping the leader. You should first have an excellent team of managers. Managers can be honest, and the team is likely to implement it. If managers are secretive and vague, then the whole team will inevitably be unable to be honest.

This article (including pictures) is reproduced by the cooperative media and does not represent the position of the entrepreneurial state. Please contact the original author for reprinting. If you have any questions, please contact editor@cyzone.cn.