Shenzhen Kangtai Biological Products Co., Ltd.Indicative Announcement on the Authorization of theInactivated COVID-19 Vaccine for Emergency Use
Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referred to as "theCompany") recently received a notice from the vaccine R&D group of the scientificresearch and development innovation team of the Joint Prevention and ControlMechanism of the State Council, according to the relevant provisions of Article 20 ofthe Vaccine Administration Law of the People's Republic of China, the inactivatedCOVID-19 vaccine developed by the Company have been put into emergency useafter the recommendations of the National Health Commission of the People'sRepublic of China and the evaluation by National Medical Products Administration.Ⅰ. Product IntroductionThe inactivated COVID-19 vaccine independently developed by the Company isused 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 inactivatedCOVID-19 vaccine have been completed in February 2021. Currently, the Companyhas 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 theemergency use listing. If the vaccine is subsequently procured and used on a largescale by the relevant national departments, a positive impact will be exerted on theCompany's business performance and the Company's core competitiveness will befurther improved.
Ⅲ. Risk Warning
1. According to Article 20 of Vaccine Administration Law of the People'sRepublic of China, in the event of a major public health emergency or otheremergencies that seriously threaten public health, the competent health authoritiesunder the State Council may propose the emergency use of vaccines based on theneeds for prevention and control of infectious diseases, and then the vaccine will beused within a certain scope and period of time with the consent of the drug regulatoryagency of the State Council.
2. Vaccine research & development is complex and rigorous, which requiresapplication for clinical trials, conduction of clinical trials, application for marketauthorization, and batch release before product launch. Company’s InactivatedCOVID-19 vaccine is still in the clinical trial stage, so there is a certain degree ofuncertainty in the subsequent development and regulatory approval stages. TheCompany will continue to promote the progress of the project and fulfill informationdisclosure obligations in accordance with the regulations of the relevant stateauthorities. Investors are urged to make cautious decisions and pay attention toinvestment risks.
It is hereby announced.
The Board of Directors of Shenzhen Kangtai Biological Products Co., Ltd.
May 14
th
, 2021