Stock Code: 688520 Stock Abbreviation: Shenzhou Cell Announcement No.: 2022-055
The company’s board of directors and all directors guarantee that there are no false records, misleading statements or major omissions in the content of this announcement, and they will bear legal responsibility for the authenticity, accuracy and completeness of the content in accordance with the law.
Recently, Shenzhou Cell Engineering Co., Ltd. (hereinafter referred to as “Shenzhou Cell Engineering”), a holding subsidiary of Beijing Shenzhou Cell Biotechnology Group Co., Ltd. (hereinafter referred to as the “Company”), received a letter from the relevant state department. According to the relevant provisions of Article 20, the company’s self-developed recombinant new coronavirus bivalent (Alpha/Beta variant) S trimer protein vaccine (project code: SCTV01C) has been approved by the relevant state departments for emergency use.
1. Basic information of the product
SCTV01C is a new generation of bivalent mutant strain recombinant protein vaccine independently developed by China Cell Engineering to solve the problems of rapid mutation of the new coronavirus and the decline of the neutralizing antibody titer and protection rate of the first-generation vaccines at home and abroad based on the original strain. It is intended to be clinically used to prevent diseases caused by novel coronavirus infection (COVID-19). The active ingredients of SCTV01C contain the recombinant S trimer protein antigens of the two main mutant strains identified by the WHO, Alpha (Alpha) and Beta (Beta), and adopt a new type of oil-in-water that can significantly enhance Th1 cells compared with traditional aluminum adjuvants. adjuvant.
SCTV01C received emergency approval from the State Drug Administration (hereinafter referred to as “NMPA”) for clinical trials in November 2021. Up to now, a number of clinical studies have been carried out at home and abroad and some interim analyzes and immune persistence analyzes have been obtained result.
Existing preclinical and clinical research data have shown that the safety of SCTV01C after vaccination is highly similar to that of inactivated vaccines; in terms of immunogenicity, the current popular Omicron (Omicron) BA.1 and BA.5 variants are both It can induce uniform and ultra-high true virus neutralizing antibody titers, respectively reaching the preset superior endpoint index compared with the inactivated vaccine and the preset non-inferior endpoint index compared with the Pfizer mRNA vaccine, showing outstanding broad-based Spectrum cross-protection advantages and high-efficiency anti-infection potential for new mutant strains that may appear in the future; in addition, the titer of neutralizing antibodies can still be maintained at a relatively high interval of 170-678 at 12 months after booster immunization with SCTV01C, showing The outstanding immune persistence of SCTV01C. For details, please refer to the relevant announcements disclosed by the company on the website of the Shanghai Stock Exchange (www.sse.com.cn).
2. Significance and impact on the company
The company’s recombinant new coronavirus 2-valent (Alpha/Beta variant) S trimer protein vaccine SCTV01C has been put into emergency use this time, and it is not expected to have a major impact on the company’s performance this year; if it is purchased and used by relevant state departments on a large scale, it will have a significant impact The company’s subsequent performance will have a certain positive impact, which will help enhance the company’s core competitiveness.
3. Risk warning
1. According to Article 20 of the “Vaccine Administration Law of the People’s Republic of China”, in the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent health department of the State Council proposes emergency use according to the needs of infectious disease prevention and control. Vaccine recommendations can be used urgently within a certain range and within a certain period of time after being approved by the drug regulatory department of the State Council.
2. SCTV01C is included in the emergency use as a temporary use and cannot replace the formal review and approval process. Due to the high-tech, high-risk, and high-value-added characteristics of vaccine products, the product clinical trial and marketing review and approval cycle is relatively long and there are many links, and the process is affected by various uncertain factors. The specific clinical research plan and research cycle It may be adjusted accordingly according to the actual situation. As of the disclosure date of this announcement, SCTV01C is still in the clinical research stage, and there are certain uncertainties in the follow-up research and development and review and approval.
3. According to WHO statistics, as of December 2, 2022, 175 COVID-19 vaccines under development worldwide have entered clinical trials. At present, more than 50 new crown vaccine products have been approved for conditional marketing or emergency use in the world, and 10 new crown vaccines (including this product) in China have been approved by the State Food and Drug Administration for conditional marketing or emergency use. Although SCTV01C is included in emergency use, its future market sales will still face relatively fierce competition. At the same time, it will be affected by various factors such as the development and changes of domestic and foreign epidemics, the new crown vaccination rate, and the company’s production capacity. There are uncertainties.
4. SCTV01C is a biological product for prophylaxis. According to the vaccination status of the vaccine, its anti-epidemic effect, level of protection for individuals and occurrence of adverse reactions may vary due to individual differences.
The company will actively promote the research and development of SCTV01C and quadrivalent vaccine SCTV01E in accordance with relevant national regulations, carry out follow-up related work and fulfill information disclosure obligations. Investors are advised to make decisions carefully and pay attention to guard against investment risks.
Special announcement.
Board of Directors of Beijing Shenzhou Cell Biotechnology Group Co., Ltd.
December 5, 2022