Business News Agency June 13 Experts suggested that the state should fully consider the actual situation of domestic vaccines in terms of prices, and gradually launch a postmarketing evaluation mechanism to encourage vaccine innovation.
The issuance of domestic vaccine lots is being tested by new standards.
Since the new version of GMP was formally implemented on March 1st, aseptic products manufacturers, such as blood products and vaccines that require the first phase of compliance, have recently entered the "pain period." A few days ago, the China Food and Drug Testing Institute released a public announcement that the number of vaccine batches issued in the first half of the year has decreased significantly compared with the same period of last year, and some of these varieties have experienced a larger decline. For example, the number of hepatitis A vaccine batches issued was 5.48 million, which was a decrease from the same period last year. 40%; Haemophilus influenzae type b vaccine was granted only 2.43 million copies, a year-on-year drop of nearly 70%. As of the end of April this year, the number of batches issued by GSK, a multinational company involved in nearly 10 vaccine fields, was zero. "In the first few months, due to the differences in standard understanding between the new GMP and the new Pharmacopoeia standards among relevant departments and enterprises, it has indeed caused troubles in the implementation of batch approvals for vaccines." Changchun Institute of Biological Products, China National Pharmaceutical Group Deputy Director Guo Lijun said in an interview with reporters.
The standard alternate test
The reporter learned that from January to April of this year, the number of Hib vaccines and meningococcal vaccine batches issued during the batch approval of vaccine batches dropped significantly year-on-year. In addition, foreign-funded enterprises failed to meet the standard in the three-link vaccine, hepatitis A vaccine, and hepatitis B vaccine, and the issuance of batches continued to be zero.
Guo Lijun said, “I think the current slowdown in batch issuing and issuance work is mainly due to the impact of the new version of the Pharmacopoeia and GMP standards. Due to differences in the formulation and implementation of standards, the number of batches sent by enterprises has been greatly reduced. According to the provisions of the implementation steps, the vaccine is required. The first batch of standards was met. At present, the vaccine field is in the period of alternation between the new and the old drug standards. In addition, the pace of new standards implemented by the provinces is inconsistent, and ultimately they directly or indirectly affect the process of batch approval.
In fact, the reduction in the number of batches issued has caused many vaccine manufacturers to be anxious. The reporter learned that mainstream vaccine companies, including Changchun, are waiting for approval of relevant products. In contrast, private vaccine companies represented by Yunnan Watson Bios are even more urgent. Li Yunchun, chairman of Watson Bio, stated that since this year, more than 2 million doses of vaccines have been sent to the Intermediate People's Court for approval. Currently, the company has only been awarded batches of Hib vaccines. “Vaccine approval is critical, and it will directly affect the performance of listed companies. We are closely watching and adjusting.†This is also accompanied by a new company in Wuhan that is in the vaccine field. They are also investigating the progress of batch issuing. Happening.
In response, Zhao Bing, an analyst at Shanghai Securities Pharmaceuticals, believes that “in the first half of this year, the reduction in the number of vaccine batches issued was actually a product of the alternating period between the old and new versions of GMP and pharmacopoeia standards.†During the interview, the reporter also learned that the WHO recently reported Measles epidemics occurred in 33 European countries such as France, Belgium and Spain. Countries began to take precautions. Coupled with the assessment of the Chinese vaccine regulatory system by the WHO, Chinese vaccines began to rank among international buyers. Zhao Bing believes that "the granting of batches is only temporary. From the overall environment, the release of demand will further stimulate the growth desire of domestic vaccine companies. In the process of alternation of old and new standards, it will inevitably lead to the survival test of the survival of the fittest. â€
Upgraded quality concept
Of course, the standard docking is only one aspect. Behind the batch of issuance and elevation thresholds, how to further promote the quality upgrade of Chinese vaccines is the real proposition facing the corporate world.
When comparing the data released by the Census Bureau, the reporter found that a total of 3.83 million copies were issued in April before China’s MMR vaccine, a year-on-year drop of 5%, but a total of 3.51 million copies were issued in Shanghai, an increase of 27%; 32 million people, an increase of 13%; GSK and Merck did not receive approval for issuance. On the other hand, in the first 4 months, a total of 2.92 million bottles of domestic human albumin were issued, an increase of 27% year-on-year; 90,000 bottles of human prothrombin complexes were issued, an increase of 50% year-on-year. The data shows that the proportion of vaccine companies issued by foreign-funded enterprises is decreasing this year, and domestic vaccines are increasing. In particular, private drug companies have increased rapidly.
What is even more striking is that Watson Bio and GSK have ceased cooperation with the Maternal Vaccine Project. It was alleged that the termination of the cooperation was due to the antibiotics contained in the product developed by the vaccine project. According to the new edition of the Chinese Pharmacopoeia, antibiotic antibiotics were used in the process and new antibiotic residue testing indicators were added to the finished product.
An industry expert who did not wish to be named told the reporter that “Upgrading the quality of vaccine products and raising the limit value of toxin residues are inevitable. For example, hepatitis B vaccine has added new genes for nucleic acid sequence detection, viable cell rates, etc. But with Europe Comparing pharmacopoeia and WHO standards, domestic research on the standards and methods for the specific activity, purity, etc. of vaccine products should also be strengthened to better guarantee the quality of vaccines.â€
In fact, vaccine companies also face the risk of price cuts. Last year, the notice issued by the National Development and Reform Commission that adjusted the ex-factory price of 14 vaccines such as hepatitis B vaccine shakes the entire vaccine industry. Analysts pointed out that "Compared with the original ex-factory price, high-priced vaccines cut prices and prices of low-priced vaccines rise, but overall, price cuts and even substantial price reductions are the main theme of this price adjustment policy. Group A meningococcal conjugate vaccine In the case of lyophilized preparations, the original ex-factory price of 10 ug was 25 yuan, the adjusted ex-factory price was 10.5 yuan, and the price was reduced by 58%. In fact, this poses a challenge to the quality and safety of vaccines."
Guo Lijun said that the technical transformation of vaccines has increased the pressure for enterprises to survive, and the price reduction factors also affect the reporting direction of enterprises. As a public product, it is recommended that the state should fully consider the actual situation of domestic vaccines in terms of vaccine prices, and gradually launch a postmarketing evaluation mechanism. Encourage vaccine innovation.
The issuance of domestic vaccine lots is being tested by new standards.
Since the new version of GMP was formally implemented on March 1st, aseptic products manufacturers, such as blood products and vaccines that require the first phase of compliance, have recently entered the "pain period." A few days ago, the China Food and Drug Testing Institute released a public announcement that the number of vaccine batches issued in the first half of the year has decreased significantly compared with the same period of last year, and some of these varieties have experienced a larger decline. For example, the number of hepatitis A vaccine batches issued was 5.48 million, which was a decrease from the same period last year. 40%; Haemophilus influenzae type b vaccine was granted only 2.43 million copies, a year-on-year drop of nearly 70%. As of the end of April this year, the number of batches issued by GSK, a multinational company involved in nearly 10 vaccine fields, was zero. "In the first few months, due to the differences in standard understanding between the new GMP and the new Pharmacopoeia standards among relevant departments and enterprises, it has indeed caused troubles in the implementation of batch approvals for vaccines." Changchun Institute of Biological Products, China National Pharmaceutical Group Deputy Director Guo Lijun said in an interview with reporters.
The standard alternate test
The reporter learned that from January to April of this year, the number of Hib vaccines and meningococcal vaccine batches issued during the batch approval of vaccine batches dropped significantly year-on-year. In addition, foreign-funded enterprises failed to meet the standard in the three-link vaccine, hepatitis A vaccine, and hepatitis B vaccine, and the issuance of batches continued to be zero.
Guo Lijun said, “I think the current slowdown in batch issuing and issuance work is mainly due to the impact of the new version of the Pharmacopoeia and GMP standards. Due to differences in the formulation and implementation of standards, the number of batches sent by enterprises has been greatly reduced. According to the provisions of the implementation steps, the vaccine is required. The first batch of standards was met. At present, the vaccine field is in the period of alternation between the new and the old drug standards. In addition, the pace of new standards implemented by the provinces is inconsistent, and ultimately they directly or indirectly affect the process of batch approval.
In fact, the reduction in the number of batches issued has caused many vaccine manufacturers to be anxious. The reporter learned that mainstream vaccine companies, including Changchun, are waiting for approval of relevant products. In contrast, private vaccine companies represented by Yunnan Watson Bios are even more urgent. Li Yunchun, chairman of Watson Bio, stated that since this year, more than 2 million doses of vaccines have been sent to the Intermediate People's Court for approval. Currently, the company has only been awarded batches of Hib vaccines. “Vaccine approval is critical, and it will directly affect the performance of listed companies. We are closely watching and adjusting.†This is also accompanied by a new company in Wuhan that is in the vaccine field. They are also investigating the progress of batch issuing. Happening.
In response, Zhao Bing, an analyst at Shanghai Securities Pharmaceuticals, believes that “in the first half of this year, the reduction in the number of vaccine batches issued was actually a product of the alternating period between the old and new versions of GMP and pharmacopoeia standards.†During the interview, the reporter also learned that the WHO recently reported Measles epidemics occurred in 33 European countries such as France, Belgium and Spain. Countries began to take precautions. Coupled with the assessment of the Chinese vaccine regulatory system by the WHO, Chinese vaccines began to rank among international buyers. Zhao Bing believes that "the granting of batches is only temporary. From the overall environment, the release of demand will further stimulate the growth desire of domestic vaccine companies. In the process of alternation of old and new standards, it will inevitably lead to the survival test of the survival of the fittest. â€
Upgraded quality concept
Of course, the standard docking is only one aspect. Behind the batch of issuance and elevation thresholds, how to further promote the quality upgrade of Chinese vaccines is the real proposition facing the corporate world.
When comparing the data released by the Census Bureau, the reporter found that a total of 3.83 million copies were issued in April before China’s MMR vaccine, a year-on-year drop of 5%, but a total of 3.51 million copies were issued in Shanghai, an increase of 27%; 32 million people, an increase of 13%; GSK and Merck did not receive approval for issuance. On the other hand, in the first 4 months, a total of 2.92 million bottles of domestic human albumin were issued, an increase of 27% year-on-year; 90,000 bottles of human prothrombin complexes were issued, an increase of 50% year-on-year. The data shows that the proportion of vaccine companies issued by foreign-funded enterprises is decreasing this year, and domestic vaccines are increasing. In particular, private drug companies have increased rapidly.
What is even more striking is that Watson Bio and GSK have ceased cooperation with the Maternal Vaccine Project. It was alleged that the termination of the cooperation was due to the antibiotics contained in the product developed by the vaccine project. According to the new edition of the Chinese Pharmacopoeia, antibiotic antibiotics were used in the process and new antibiotic residue testing indicators were added to the finished product.
An industry expert who did not wish to be named told the reporter that “Upgrading the quality of vaccine products and raising the limit value of toxin residues are inevitable. For example, hepatitis B vaccine has added new genes for nucleic acid sequence detection, viable cell rates, etc. But with Europe Comparing pharmacopoeia and WHO standards, domestic research on the standards and methods for the specific activity, purity, etc. of vaccine products should also be strengthened to better guarantee the quality of vaccines.â€
In fact, vaccine companies also face the risk of price cuts. Last year, the notice issued by the National Development and Reform Commission that adjusted the ex-factory price of 14 vaccines such as hepatitis B vaccine shakes the entire vaccine industry. Analysts pointed out that "Compared with the original ex-factory price, high-priced vaccines cut prices and prices of low-priced vaccines rise, but overall, price cuts and even substantial price reductions are the main theme of this price adjustment policy. Group A meningococcal conjugate vaccine In the case of lyophilized preparations, the original ex-factory price of 10 ug was 25 yuan, the adjusted ex-factory price was 10.5 yuan, and the price was reduced by 58%. In fact, this poses a challenge to the quality and safety of vaccines."
Guo Lijun said that the technical transformation of vaccines has increased the pressure for enterprises to survive, and the price reduction factors also affect the reporting direction of enterprises. As a public product, it is recommended that the state should fully consider the actual situation of domestic vaccines in terms of vaccine prices, and gradually launch a postmarketing evaluation mechanism. Encourage vaccine innovation.
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