In just half a month, many Chinese companies disclosed their progress in the field of mRNA vaccine. MRNA domestic covid-19 vaccine once again entered the public eye.
Anhui Anke Biotechnology (Group)Co.Ltd(300009) 4 announced on the evening of April 13 that the company recently signed the strategic cooperation framework agreement with Hefei afana Biotechnology Co., Ltd. (hereinafter referred to as "afana"). The two sides establish a strategic partnership, give full play to their respective advantages and carry out exclusive cooperation in preclinical research, clinical research, industrialization and marketing of "covid-19 Omicron and other mutant mRNA vaccine" developed by afana.
The announcement said that at present, the project has completed pharmaceutical and pharmacodynamic research, and is conducting safety evaluation experiments and sorting out relevant materials of clinical trial application. In the near future, afana and the company will jointly submit drug clinical trial application to the State Drug Administration.
On the 3rd and 4th of this month, Cansino Biologics Inc(688185) biological and stone Pharmaceutical Group successively announced its mRNA vaccine, which was approved by the State Drug Administration to carry out clinical trials. Among them, based on its advantages in safety, effectiveness and industrialization, and according to the needs of epidemic prevention and control, covid-19 mRNA vaccine sys6006 of Shijiazhuang Pharmaceutical Group was also included in the special approval procedure by the State Drug Administration to quickly approve its entry into clinical practice.
On April 3, it was reported that Sri Lanka microorganism was accelerating the research and development of covid-19 mRNA iterative vaccine. At present, it has submitted a paper application to the State Food and drug administration to carry out clinical trials and strive to be approved for listing as soon as possible. In terms of production capacity, Si microorganism has built modern production plants in Zhoupu and Fengxian, Shanghai, which can achieve 400 million doses / year.
Recently, Yunding Xinyao also signed a memorandum of cooperation with China Resources medicine. China Resources medicine not only plans to invest in Yunding Xinyao's mRNA technology platform, but also will establish an independent company with Yunding Xinyao to discover, develop and commercialize mRNA vaccines.
7 companies compete in "mRNA" track
According to the reporter's incomplete statistics, up to now, the mRNA vaccines of 7 enterprises in China have entered the clinical stage.
Yunding Xinyao announced to work with China Resources medicine to develop mRNA vaccine. Earlier, in September 2021, Yunding Xinyao introduced the rights and interests of provience's mRNA vaccine ptx-covid19-b in Asian emerging markets such as greater China, Southeast Asia and Pakistan, and authorized to use its platform to develop mRNA products worldwide. Ptx-covid19-b is currently in phase 2 of the world.
the mRNA vaccine arcov jointly developed by Walvax Biotechnology Co.Ltd(300142) and Aibo biology is in two phase III clinical trials. On January 24, 2022, its phase I clinical data showed that arcov was safe, well tolerated and strongly induced immune response at all five doses.
Shanghai Siwei biological (Australian clinical phase I was enrolled in March 2022, and the mRNA iterative vaccine has been submitted to ind) and Zhuhai rivanda biological mRNA (recruited by phase II patients in March 2022) vaccine have entered clinical phase II.
Ruibo biology / agna Biology (phase I was launched in Chengdu on January 10, 2022), kangxinuo Biology (ind was approved on April 4, 2022) and Shiyao group (ind was approved on April 3, 2022) have entered the clinic.
Chinese vaccine companies maintain such high enthusiasm for the mRNA technology route, not only because the mRNA products of Pfizer and Modena have received excellent feedback from the global market. The protective effect of vid-19 vaccine has been significantly improved after three doses of vaccine, and the protective effect of vid-19 vaccine has been significantly improved
In the past year, many studies have compared the efficacy of the vaccine against covid-19. Although they all pointed out that no matter what type of vaccine can effectively prevent severe illness and death, mRNA vaccine is better than all technical routes. Dr. Zhang Wenhong and academician Zhong Nanshan mentioned this in their recent public speeches.
On March 24, Zhang Wenhong, director of the infection department of Huashan Hospital Affiliated to Fudan University, posted a microblog saying that both inactivated and mRNA vaccines can prevent serious diseases and deaths. Among adults aged ≥ 60, the protection rate of two inactivated vaccines against severe covid-19 and death was 74.1%, which was lower than 88.2% of bnt162b2 (mRNA vaccine). The above comparative data cite a study by the University of Hong Kong published on the preprint platform medrxiv on March 22. Studies have shown that there is a large gap between inactivated vaccine and mRNA vaccine in preventing infection, but after three doses of vaccination, the efficacy of preventing severe illness and death has increased to a considerable level.
On April 8, Zhong Nanshan, an academician of the Chinese Academy of engineering, mentioned in the live broadcast of "scientific guidance on epidemic resistance and bravely climbing the medical peak" for Nankai University online that according to China's "dynamic clearing" strategy, it is recommended to use xenogeneic vaccine as sequential vaccination.
In the course, academician Zhong Nanshan shared the real-world data of heterologous vaccination in Brazil. The study observed more than 14.36 million subjects and found that the effective rate of preventing infection was 55% 14 to 30 days after two doses of Kexing vaccine; After 180 days, the effective rate of infection prevention was 34.7%. After 14-30 days, the effective rate of preventing severe disease was 82.1%; After 180 days, the effective rate of preventing severe diseases was 72.5%. After inoculation with two doses of Kexing vaccine and enhanced immunization with mRNA vaccine for 14-30 days, the infection prevention rate can be as high as 92.7% and the severe prevention rate can be as high as 97.3%.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) and fubitai
When it comes to mRNA vaccine, there is another unavoidable role, that is, fubitai, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) agent of biontech.
In July 2021, Wu Yifang, then Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) chairman and CEO, said at the shareholders' meeting that the approval of Fosun mRNA covid-19 vaccine "fubitai" by the State Food and Drug Administration had been basically completed, the expert review had been passed, and the administrative approval was being stepped up.
However, in the semi annual report disclosed in August Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) disclosure, the status of Fosun mRNA covid-19 vaccine became "still in phase II clinical stage".
On March 29 this year, Shanghai issued several policies and measures of Shanghai to fight the epidemic and help enterprises promote development, which proposed to "support the import of covid-19 virus vaccine and therapeutic drugs". On the same day, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) closed up 7.78%, and the secondary market saw hope for the approval of Fosun mRNA covid-19 vaccine.
According to the company's financial report in 2021, fubitai carried out vaccination in Hong Kong, Macao and Taiwan in March and September 2021 respectively. During the reporting period, about 22 million doses were vaccinated in Hong Kong, Macao and Taiwan, realizing sales of more than 1 billion yuan.
As a result, fubitai became Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) the third single preparation with an annual sales scale of more than 1 billion yuan in 2021, in addition to hanlikang (rituximab injection) and heparin series preparations. The revenue of Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) 's anti infection core product business doubled year-on-year, reaching an increase of 119.54%.
China's mRNA technology still has shortcomings
Although mRNA technology has a long history, it has not been long for it to be applied.
The reporter interviewed the staff of a vaccine enterprise and learned that although there are some upstream and downstream representative listed companies in the local mRNA vaccine industry chain, these companies have more realized the industrialization of one link. In other production and preparation links, most of them either stay in the stage of technological breakthrough, or still rely heavily on imports.
In addition, in addition to technical barriers, the ecological environment of mRNA vaccine in China is not complete, and most of the raw materials and equipment required for mRNA drug research and development need to be imported. It will take a long time to achieve a breakthrough in the whole industry chain of mRNA technology.
For the general concern of the public, there is no doubt about why China's mRNA vaccine has not been approved. In fact, it is not to wait for the research and development progress of domestic mRNA vaccine, but the regulatory authorities are more concerned about safety.
Southwest Securities Co.Ltd(600369) a research report pointed out that the core production process of mRNA vaccine has three steps: mRNA preparation, LNP delivery and combination and large-scale production. "One of the three is indispensable. The vaccine is not achieved overnight. Generally speaking, it is not only the technology that needs to be tested, but also the completeness and matching degree of the overall upstream, middle and downstream industrial chain." The above respondents said.
