Walvax Biotech receives approval for 20-valent pneumococcal vaccine trial

Walvax Biotechnology Co., Ltd. (SZSE:300142) and its subsidiaries, Yunnan Vaccine Laboratory Co., Ltd. and Yuxi Walvax Biotechnology Co., Ltd., have received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for their 20-valent pneumococcal polysaccharide conjugate vaccine. The approval notice, numbered 2025LP01099, covers preventative biological products. The trials will assess the vaccine's efficacy in children aged 2 months (minimum 6 weeks) to 5 years against invasive diseases caused by the 20 pneumococcal serotypes included in the vaccine. The 20-valent vaccine builds upon Walvax's existing 13-valent pneumococcal polysaccharide conjugate vaccine, adding seven new serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). The company's 13-valent vaccine, approved in December 2019, was the first domestically produced and second globally available version, with over 27 million doses released since 2020. Walvax cautions that the timeline and outcome of the clinical trials are subject to uncertainties.