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Super heavy! Sinopharm's new crown vaccine has been marketed with conditions!

Writer: SEKSUN Release date:2022-08-02 View:24

Today is the last day of 2020, but it is destined to be an extraordinary day. After waiting for a long time, finally, Sinopharm Group's China Bio-New Crown Inactivated Vaccine has been approved by the State Food and Drug Administration for listing with conditions!


♦On December 24, 2020, the NMPA accepted the marketing application for the new coronavirus inactivated vaccine (Vero) of Sinopharm Beijing Institute of Biological Products.


♦On December 30, Sinopharm Group's new crown inactivated vaccine phase III clinical trial analysis data was released, and the vaccine's protective efficacy against diseases caused by new crown virus infection was 79.34%.


♦On the morning of December 31, it was announced at a press conference held by the Joint Prevention and Control Mechanism of the State Council that Sinopharm's China Bio-New Crown Inactivated Vaccine has been approved by the State Food and Drug Administration for listing with conditions.


With the launch of Sinopharm's inactivated vaccine, my country's first self-developed new crown vaccine officially landed in the domestic market.


(1) Overview of Sinopharm Group


Sinopharm Group is the only central pharmaceutical enterprise directly managed by the State-owned Assets Supervision and Administration Commission of the State Council, which focuses on the pharmaceutical and health industry, and is a national innovative enterprise. It has more than 1,500 subsidiaries and Sinopharm Holding (01099.HK), Sinopharm (600511.SH), Sinopharm Accord (000028.SZ200028.SZ), Tiantan Biological (600161.SH), Modern Pharmaceutical (600420.SH), China Traditional Chinese Medicine (00570.HK) 6 listed companies with a total number of 150,000 employees. The Wuhan Institute of Biological Products and the Beijing Institute of Biological Products, which are responsible for the research and development of the new crown vaccine this time, belong to the research institutes of China Biotechnology Co., Ltd., which is a member of Sinopharm Group.


(2) Sinopharm Group Inactivated Vaccine


The two new crown vaccines under development by Sinopharm are inactivated vaccines. Inactivated vaccine is the most traditional classic technical route of vaccine. By culturing the new coronavirus in vitro, then inactivating it to eliminate its toxicity, and then reintroducing the inactivated virus into the body. After the inactivated virus enters the body, due to its antigenicity, Stimulates the immune system to produce antibodies. Inactivated vaccines must be produced in the P3 laboratory, and if large-scale production is required, the laboratory's biosafety and detection technology must reach world-class standards. my country's layout in P3 laboratories is relatively early, the technology is relatively mature, and the overall inactivated vaccine is at the forefront of the world.


The advantages of inactivated vaccines are that the preparation method is mature and the safety is high, and the inactivated virus no longer has the ability to infect and replicate. However, because the immunogenicity and immune protection of inactivated vaccines are lower than that of attenuated vaccines, inactivated vaccines have disadvantages such as large inoculation doses and short immunization cycles.


In April, the two vaccines successively obtained clinical approvals. On April 12, the COVID-19 inactivated vaccine developed by the Wuhan Institute of Biological Products was approved for clinical trials, and domestic phase I/II clinical trials were carried out simultaneously. On April 27, the new crown inactivated vaccine developed by the Beijing Institute of Biological Products was approved for clinical trials again, adding double insurance to the research and development of the new crown vaccine.


Phase I and II clinical trials have excellent data. On August 13, the international medical journal "Journal of the American Medical Association" published the results of the phase I/II clinical trial of the new crown inactivated vaccine of the Wuhan Institute of Sinopharm. In the phase I clinical trial, the low, medium and high dose groups and aluminum adjuvant A total of 96 volunteers in the control group received three vaccinations on days 0/28/56. In the phase II clinical trial, 224 volunteers received two medium-dose vaccinations on days 0/14 and 0/21. The results showed that 14 days after three vaccinations in phase I clinical trials, the low, medium and high doses of the vaccine induced 316, 206 and 297 geometric mean titers of serum neutralizing antibodies in volunteers, respectively. In the phase I trial, the antibody response started after the second injection, and the antibody remained at a high level 14 days after the third injection; in the phase II clinical trial, 0/14 and 0/21 received two medium-dose vaccines 14 days later. The mean titers of serum neutralizing antibodies induced by the vaccine in volunteers were 121 and 247, respectively. The results of Phase I/II clinical trials show that Sinopharm's new crown vaccine can effectively induce neutralizing antibodies.


Emergency use has been launched abroad in September. On September 14 and November 3, the UAE and Bahrain respectively announced that Sinopharm’s new crown vaccine was used for emergency use in their own countries. The UAE’s emergency vaccination personnel included Vice President and Prime Minister Al Maktoum.


It was approved for listing in the United Arab Emirates on December 9, with an effective rate of 86%, and no serious safety hazards were found. On December 9, the UAE Ministry of Health and Prevention announced the registration of the new coronavirus inactivated vaccine developed by Sinopharm China Bio-Beijing Product Research Institute in the country. The UAE Ministry of Health and Prevention has reviewed the Phase 3 clinical trial data submitted by Sinopharm China Biotech, and the clinical trial conducted on about 31,000 volunteers with 125 different nationalities showed that Sinopharm Zhongsheng vaccine is effective against new coronavirus infection. It is 86% resistant, and the neutralizing antibody conversion rate is 99%, which can prevent 100% of moderate and moderate cases of new coronary pneumonia. And related studies have not found that there are serious safety hazards in the vaccine.


So far, 14 vaccines from 5 technical routes in my country have entered clinical trials, of which 5 vaccines from 3 technical routes have entered Phase III clinical trials.


(3) Other COVID-19 vaccines in Phase III clinical trials


In addition to the two inactivated vaccines of Sinopharm Group, the inactivated vaccine of Kexing Bio, the inactivated vaccine of Kangtai Bio (Minhai Bio), the inactivated vaccine of the Chinese Academy of Medical Sciences, the recombinant protein vaccine of Zhifei Bio, and the inactivated vaccine of CanSino Adenovirus vector vaccines are all in clinical phase III. (five)


The general name of Sinovac's inactivated vaccine is Novel Coronavirus Inactivated Vaccine (Vero Cell), and the trade name is Kerrlife. In the Phase I and Phase II clinical trials, the company included a total of 5,000 people to participate in the trial. In the blind review and unblinding meeting in June, the Phase I/II safety data showed that the adverse reactions of the vaccine were mainly grade 1, and the main manifestations were as follows: There was mild pain at the inoculation site, and individual subjects experienced fatigue and low-grade fever, and no serious adverse reactions were reported. The results of the phase II clinical study showed that the positive conversion rate of neutralizing antibodies exceeded 90% after 14 days of immunization, and the vaccine was highly immunogenic. Phase III clinical trials are currently being carried out in Brazil, Indonesia and other countries. On November 28, at the 2020 First China Health Technology Innovation and Development Conference, Yin Weidong, chairman of Sinovac Holdings Biotechnology Co., Ltd., said that the mid-term analysis is expected to be completed in mid-December.


The adenovirus vector vaccine of CanSino and the Academy of Military Sciences is constructed by genetic engineering methods, using replication-defective adenovirus as a vector, which can express the new coronavirus S protein, and is used to prevent diseases caused by new coronavirus infection. On July 21, the results of the Phase II trial of the new crown vaccine were published in The Lancet. In the experiment, 508 eligible subjects were randomly assigned to a low-dose group of 5*1010 virus particles (250 people), 1*1011 virus The results showed that the peak value of ELISA antibody in the low-dose group was 571 in the middle-dose group (125 people) and the placebo group (125 people), and the peak ELISA antibody in the middle-dose group was 656.6. The positive conversion rates of serum antibodies in the two dose groups were respectively 96% and 97%. At the same time, the adenovirus vector vaccine vector can effectively stimulate cellular immunity. The response rates of IFNγ-ELISpot in the low-dose and middle-dose groups were 90% and 88%, respectively, and cellular immunity could effectively remove infected cells.


Zhifei Bio's recombinant protein subunit vaccine is to prepare a vaccine from the S protein receptor binding region antigen of the new coronavirus expressed by recombinant engineering cells, and inoculate it into the human body to stimulate the human body to produce antibodies. Zhifei Bio’s recombinant protein vaccine showed good safety in Phase I and II clinical trials, and no obvious adverse reactions were found. In terms of immunogenicity, the positive conversion rate of the Phase I clinical trial was 100%, the positive conversion rate of the Phase II clinical trial was 96.6%, the GMT value of the neutralizing antibody in the Phase I clinical trial was 94.5, and the GMT value of the neutralizing antibody in the Phase II clinical trial was over 100.


Kangtai Bio's inactivated vaccine entered clinical phase III in Malaysia in early December. In December, the Malaysian listed company YONGTAIBERHAD announced that the company has reached a cooperation with Shenzhen Kangtai Biological Products Co., Ltd. and KLINSELSDNBHD to promote the Phase III clinical trial of Kangtai Biological's new crown inactivated vaccine in Malaysia. The company will have exclusive commercialization rights after the successful conclusion of the Phase III clinical trial or obtain emergency use rights in Malaysia, and the two parties plan to collaborate on approximately 100 million doses of the vaccine over a five-year procurement plan.


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