Securities code: 300601 securities abbreviation: Shenzhen Kangtai Biological Products Co.Ltd(300601) Announcement No.: 2022-002 bond Code: 123119 bond abbreviation: Kangtai transfer 2
Shenzhen Kangtai Biological Products Co.Ltd(300601)
Announcement on the receipt by the wholly-owned subsidiary of the notice on the on-site verification of the registration of freeze-dried human rabies vaccine (human diploid cells)
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Beijing minhai Biotechnology Co., Ltd. (hereinafter referred to as “minhai biotechnology”), a wholly-owned subsidiary of Shenzhen Kangtai Biological Products Co.Ltd(300601) (hereinafter referred to as “the company”), recently received the notice of the drug review center on initiating the on-site verification of the registration of freeze-dried human rabies vaccine (human diploid cells) issued by the drug review center of the State Drug Administration (hereinafter referred to as “the drug review center”) (hereinafter referred to as the “notice”), according to the relevant provisions of the measures for the administration of drug registration, the drug examination center shall start the drug registration verification (Pharmacy) of the lyophilized human rabies vaccine (human diploid cells) (acceptance No.: cxss2101046) applied for registration by minhai biology.
1、 Product introduction
Lyophilized human rabies vaccine (human diploid cells) is used to prevent rabies. Rabies is an acute zoonotic infectious disease caused by rabies virus. Its clinical manifestations are unique fear of water, wind, pharyngeal muscle spasm and progressive paralysis. Once there are symptoms, the mortality is close to 100%. Vaccination against rabies is an effective way to control and prevent rabies.
The freeze-dried human rabies vaccine (human diploid cells) developed by minhai biology is prepared from human diploid cells. The clinical results show that it has good safety, immunogenicity and immune persistence. China has a large demand for rabies vaccine, and the market prospect of the vaccine is good.
2、 Progress and significance
1. The notification indicates that important progress has been made in the registration of freeze-dried human rabies vaccine (human diploid cells) developed by minhai biology. The registration on-site verification will begin soon. After passing the relevant review and approval procedures such as technical review and registration on-site verification, the product will be able to obtain the drug registration approval.
2. If the product is registered successfully, it will further enrich the company’s product echelon, enhance the company’s competitiveness and strengthen the company’s market position.
3、 Risk tips
Vaccine research and development is a complex and rigorous scientific activity with great difficulty and long cycle. Before marketing, it is necessary to apply for clinical trials, conduct clinical trials, apply for drug registration approvals and issue product batches. According to the relevant administrative approval procedures, the final approval result and time of the registration approval document of freeze-dried rabies vaccine for human use (human diploid cells) drugs are uncertain. The company will timely perform the obligation of information disclosure for the follow-up progress of the product. Please make careful decisions and pay attention to investment risks.
4、 Documents for future reference
1. Notice of the drug examination center on initiating the on-site verification of the registration of freeze-dried human rabies vaccine (human diploid cells) issued by the drug evaluation center of the State Drug Administration.
It is hereby announced.
Shenzhen Kangtai Biological Products Co.Ltd(300601) board of directors January 23, 2022
