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In just half a month, a number of domestic companies disclosed their progress in the field of mRNA vaccines. The mRNA domestic new crown vaccine has once again entered the public eye.
Anke Bio announced on the evening of April 13 that the company recently signed a Strategic Cooperation Framework Agreement with Hefei Afana Biotechnology Co., Ltd. (hereinafter referred to as "Afana"). The two sides have established a strategic partnership to give full play to their respective advantages and carry out exclusive cooperation on the preclinical research, clinical research, industrialization and marketing of the "mRNA vaccine for mutant strains such as COVID-19 Omicron" developed by Afana.
The announcement said that at present, the project has completed pharmaceutical and pharmacodynamic studies, is conducting safety evaluation experiments, sorting out the relevant information of clinical trial applications, and recently plans to submit drug clinical trial applications to the State Drug Administration jointly by Afara and the company.
On the 3rd and 4th of this month, CanSino Biologics and CSPC Pharmaceutical Group successively announced the mRNA vaccine they developed, which was approved by the State Drug Administration to carry out clinical trials. Among them, based on its advantages in safety, efficacy and industrialization, and according to the needs of epidemic prevention and control, CSPC's new crown mRNA vaccine SYS6006 was also included in the special approval procedure by the State Drug Administration, and was quickly approved to enter the clinic.
On April 3, it was reported that Si Microbial is accelerating the development of an iterative covid-19 mRNA vaccine, and has submitted a paper application to the State Food and Drug Administration to carry out clinical trials and strive to be approved for marketing as soon as possible. In terms of production capacity, Si Microbi has built modern production plants in Zhoupu and Fengxian in Shanghai, which can achieve 400 million doses/year.
Recently, Genting Sun Yao also signed a memorandum of cooperation with CR Pharma, which not only intends to invest in Genting Shin Yao's mRNA technology platform, but also establishes an independent company with Genting Shin Yao to discover, develop and commercialize mRNA vaccines.
7 companies compete in the "mRNA" track
According to the reporter's incomplete statistics, as of now, 7 domestic companies have entered the clinical stage of mRNA vaccines.
Genting Shin Yao announces collaboration with Cr Pharma to develop an mRNA vaccine. Earlier in September 2021, Genting ShinYao introduced Providence's mRNA vaccine PTX-COVID19-B in emerging asian markets such as Greater China, Southeast Asia, Pakistan, and authorized the use of its platform to develop mRNA products worldwide, PTX-COVID19-B is currently in phase 2 of the global phase.
The mRNA vaccine ARCoV, jointly developed by Watson Biologics and Abbott Biologics, is in two clinical Phase III trials. On January 24, 2022, its Phase I clinical data showed that ARCoV was safely tolerated at all five groups of doses and strongly induced an immune response.
Shanghai Siwei Bio (Admitted to The Australian Phase I Clinical Group in March 2022, the mRNA iteration vaccine has been submitted to IND) and the Zhuhai Livanda Bio mRNA (Phase II Patient Recruitment in March 2022) vaccines have entered Clinical Phase II.
Ruibo Bio/Agna Biotech (launched Phase I in Chengdu on January 10, 2022), Kangxinuo Bio (approved IND on April 4, 2022), and CSPC Pharmaceutical Group (APPROVED on April 3, 2022) have entered the clinic.
Domestic 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. Moreover, the clinical data on the protective efficacy of the basic immunity of mRNA new crown vaccine were excellent, and the protective power of the mutant strain after three injections was also significantly improved, surpassing the new crown vaccines that have been listed in other technical routes.
In the recent year, a number of studies have compared the efficacy of vaccines against COVID-19, and although they all point out that no matter what type of vaccine can be effective in preventing severe illness and death, the mRNA vaccine is better combined with all the technical routes. On this point, both Dr. Zhang Wenhong and Academician Zhong Nanshan mentioned it in their recent public statements.
On March 24, Zhang Wenhong, director of the Department of Infectious Diseases at Huashan Hospital affiliated to Fudan University, posted on Weibo that both inactivated and mRNA vaccines can prevent serious disease and death, and in adults aged ≥ 60 years, the two-dose inactivated vaccine has a protection rate of 74.1% against severe COVID-19 and death, which is not as good as BNT162b2 (mRNA vaccine) of 88.2%. The above comparison data is quoted from a study by the University of Hong Kong published on March 22 on the preprint platform medRxiv. Studies have shown that inactivated vaccines are quite different from mRNA vaccines in preventing infection, but after completing three doses, the effectiveness of 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 Nankai University's "Scientific Guidance to Fight the Epidemic and Bravely Climb the Peak of Medicine" online that according to the mainland's "dynamic zero clearance" strategy, it is recommended to use xenophragm vaccines as a 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 14 to 30 days after the two doses of TheOxing vaccine was 55% effective in preventing infection; after 180 days, the effectiveness of infection prevention was 34.7%. After 14-30 days, the effective rate of preventing severe disease reached 82.1%; after 180 days, the effective rate of preventing severe disease reached 72.5%. After receiving the two-shot Kexing vaccine, and then using the mRNA vaccine to strengthen immunity for 14-30 days, the infection prevention rate can be as high as 92.7%, and the prevention of severe diseases can reach 97.3%.
Fosun Pharma and Fupitech
When it comes to mRNA vaccines, there is also a role that cannot be avoided, that is, Fosun Pharma's agent BioNtech's Fupitech.
In July 2021, Wu Yifang, then chairman and CEO of Fosun Pharma, said at the shareholders' meeting that the Approval of Fosun's mRNA vaccine "Fubitai" by the State Food and Drug Administration has been basically completed, the expert review has been passed, and administrative approval is currently being stepped up.
However, in the semi-annual report disclosed by Fosun Pharma in August, the status of Fosun's mRNA new crown vaccine became "still in phase II clinical stage".
On March 29 this year, Shanghai issued the "Several Policies and Measures for Shanghai to Fight the Epidemic and Help Enterprises Promote Development", which proposes to "support the import of covid-19 vaccines and therapeutic drugs". On the same day, Fosun Pharma closed up 7.78%, and the secondary market saw hope for the approval of Fosun's mRNA vaccine.
According to the company's 2021 financial report, Fubitai carried out vaccination in March and September 2021 in Hong Kong, Macao and Taiwan, respectively, and about 22 million doses were administered in Hong Kong, Macao and Taiwan during the reporting period, achieving sales of more than 1 billion yuan.
As a result, Fubitai became fosun pharma's third annual sales scale of more than 1 billion yuan in addition to Hanlikang (rituximab injection) and heparin series preparations in 2021, and Fosun Pharma's anti-infection core product business achieved a year-on-year doubling of revenue, reaching an increase of 119.54%.
There are still shortcomings in domestic mRNA technology
Although mRNA technology has a long history, it has not been long since it has really been implemented at the application level.
The reporter interviewed the staff of a vaccine company 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 of the links. In other production and preparation links, most of them either stay in the stage of technical attack or still rely heavily on imports.
In addition, in addition to technical barriers, the ecological environment of domestic mRNA vaccines 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, why the domestic mRNA vaccine has not been approved for a long time. In fact, it is not to wait for the research and development progress of domestic mRNA vaccines, but the regulatory authorities are more for safety considerations.
A research report by Southwest Securities pointed out that the core production process of mRNA vaccines has three steps, namely mRNA preparation, LNP delivery binding and large-scale production. "All three are indispensable. Vaccines are not achieved overnight, in general, it is not only the technology that has to be tested, but also the completeness and matching degree of the overall upstream, middle and downstream industrial chains. The above-mentioned interviewees said.
Editor: Yao Jiong Editor:Zhang Xiaoguang
Proofreader: Sun Jiehua Producer: Zhang Wei Editor: Zhao Yanyi
Producer: Pu Hongyi Issued: Pan Linqing