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公司公告

康泰生物:关于新型冠状病毒灭活疫苗纳入紧急使用的提示性公告(英文版)2021-05-14  

                        Stock code: 300601     Abbreviation: BIOKANGTAI Announcement No.: 2021-041


         Shenzhen Kangtai Biological Products Co., Ltd.
     Indicative Announcement on the Authorization of the
       Inactivated COVID-19 Vaccine for Emergency Use

      The Company and all members of the Board of Directors warrant that the

 information disclosed is authentic, accurate and complete, and there are no false

 representations, misleading statements or material omissions.

     Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referred to as "the
Company") recently received a notice from the vaccine R&D group of the scientific
research and development innovation team of the Joint Prevention and Control
Mechanism of the State Council, according to the relevant provisions of Article 20 of
the Vaccine Administration Law of the People's Republic of China, the inactivated
COVID-19 vaccine developed by the Company have been put into emergency use
after the recommendations of the National Health Commission of the People's
Republic of China and the evaluation by National Medical Products Administration.
     Ⅰ. Product Introduction
     The inactivated COVID-19 vaccine independently developed by the Company is
used to prevent epidemic diseases caused by COVID-19, which belongs to Category
1.1 of Preventive Biological Products. Phases I and II clinical trials of the inactivated
COVID-19 vaccine have been completed in February 2021. Currently, the Company
has started related work of Phase III clinical trial of inactivated COVID-19 vaccine.
     Ⅱ. Impact on Company
     The Company's inactivated COVID-19 vaccine has been included in the
emergency use listing. If the vaccine is subsequently procured and used on a large
scale by the relevant national departments, a positive impact will be exerted on the
Company's business performance and the Company's core competitiveness will be
further improved.
     Ⅲ. Risk Warning
     1. According to Article 20 of Vaccine Administration Law of the People's
Republic of China, in the event of a major public health emergency or other
emergencies that seriously threaten public health, the competent health authorities
under the State Council may propose the emergency use of vaccines based on the
needs for prevention and control of infectious diseases, and then the vaccine will be
used within a certain scope and period of time with the consent of the drug regulatory
agency of the State Council.
     2. Vaccine research & development is complex and rigorous, which requires
application for clinical trials, conduction of clinical trials, application for market
authorization, and batch release before product launch. Company’s Inactivated
COVID-19 vaccine is still in the clinical trial stage, so there is a certain degree of
uncertainty in the subsequent development and regulatory approval stages. The
Company will continue to promote the progress of the project and fulfill information
disclosure obligations in accordance with the regulations of the relevant state
authorities. Investors are urged to make cautious decisions and pay attention to
investment risks.


     It is hereby announced.


     The Board of Directors of Shenzhen Kangtai Biological Products Co., Ltd.
                                                                      May 14th , 2021