Walvax Biotechnology (300142.SZ): The clinical research application for a 20-valent pneumococcal polysaccharide conjugate vaccine has been accepted.

date
21/01/2025
avatar
GMT Eight
Walvax Biotechnology (300142.SZ) announced that the 20-valent pneumococcal polysaccharide conjugate vaccine developed jointly by the company and its subsidiaries Yuxi Walvax Biotechnology Technology Co., Ltd. and Yunnan Vaccine Laboratory Co., Ltd. has applied for clinical trials with the National Medical Products Administration and has recently received the "Acceptance Notice". The 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) is a product developed independently by the company. It is an upgraded product based on the 13-valent pneumococcal polysaccharide conjugate vaccine already produced and marketed by the company, covering more pneumococcal serotypes. After vaccination with this vaccine, the body can produce immunity to prevent infectious diseases caused by the 20 serotypes of pneumococcal bacteria included in the vaccine. Currently, the domestic pneumonia conjugate vaccine market is mainly dominated by the 13-valent pneumococcal polysaccharide conjugate vaccine, with no approval for the marketing of the 20-valent pneumococcal polysaccharide conjugate vaccine. According to the relevant regulations of the National Drug Registration, after the company's application for clinical trials of the 20-valent pneumococcal polysaccharide conjugate vaccine is accepted, it will undergo technical evaluation by the drug evaluation unit of the National Medical Products Administration. Clinical trials can only be carried out after approval, and there is a certain degree of uncertainty in the outcome of the evaluation and approval process.

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