Announcement on the Acceptance of Application for Clinical Trial of 20-valent Pneumococcal Polysaccharide Conjugate Vaccine

January 26, 2024  Source: drugdu 50

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Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as "BIOKANGTAI"), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as "the Company"), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as "20-valent Pneumococcal Conjugate Vaccine") developed by BIOKANGTAI. (hereinafter referred to as "Minhai Biotechnology"), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology:

I. Main contents of the acceptance notice
Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the "People's Republic of China Administrative License Law", Article 32 of the provisions of the review, it was decided to be accepted. Within 60 days from the date of acceptance, if no negative or questionable opinion is received from the Drug Review Center, Minhai Biotechnology can carry out the clinical trial in accordance with the submitted plan.

II. Basic information of the product
20-valent Pneumococcal Polysaccharide Conjugate Vaccine (PPCV) is suitable for infants and children aged between 2 months and 5 weeks. After vaccination, this vaccine can generate immune response in the body, and is used for the prevention of invasive diseases caused by 20 pneumococcal serotypes (including bacteremic pneumonia, meningitis, sepsis and bacteremia). At present, Pfizer is the only manufacturer of 20-valent pneumococcal polysaccharide conjugate vaccine in the world.

III. Impact on the Company and Risk Warning
The notification of acceptance of the clinical trial of the 20-valent pneumococcal polysaccharide conjugate vaccine demonstrates that the Company has made new progress in another important R&D project in the field of multiplex multivalent vaccines, which is conducive to further enriching the Company's product portfolio, enhancing the Company's core competitiveness and market position, and laying a solid foundation for the Company's sustained and steady development.

Vaccine research and development is a complex and rigorous scientific activity with great difficulty and long period of time, which requires application for clinical trial, clinical trial, application for drug registration approval and product approval and issuance before marketing. The application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine has been accepted, and it is still necessary to obtain the implied approval for the clinical trial before the clinical trial can be carried out in accordance with the relevant regulations and requirements of the national drug registration, and after the completion of the clinical trial, it is still necessary to apply for registration and declaration in accordance with the prescribed procedures. The process and results of the clinical trial and the progress of product launch are uncertain, and the Company will fulfill its information disclosure obligations in a timely manner in accordance with the regulations. The Company will fulfill its information disclosure obligations in a timely manner in accordance with the regulations. Investors are advised to make decisions with caution and pay attention to investment risks.

http://www.cninfo.com.cn/new/disclosure/detail?stockCode=300601&announcementId=1218978769&orgId=9900030794&announcementTime=2024-01-23

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