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WALVAX: The clinical trial report for the 13-valent pneumococcal polysaccharide conjugate vaccine Indonesia 2p+1 immuniz…

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WALVAX announced that its subsidiary Yuxi WALVAX received the report of the Phase III clinical trial for the 13-valent pneumococcal polysaccharide conjugate vaccine conducted in Indonesia under the "2p+1" immunization program. The results show that the vaccine trial fully achieved the preset goals, marking the successful completion of its overseas Phase III clinical research in Indonesia

According to the Zhitong Finance APP, WALVAX (300142.SZ) announced that its subsidiary Yuxi WALVAX Biotechnology Co., Ltd. (hereinafter referred to as "Yuxi WALVAX") recently received the report of the Phase III clinical trial for the 13-valent pneumococcal polysaccharide conjugate vaccine (trade name "Weuphoria", hereinafter referred to as "13-valent conjugate vaccine" or "the vaccine") conducted in Indonesia under the "2p+1" immunization program (2 and 4 months for primary immunization + 12-15 months for booster immunization). The report indicates that the Phase III clinical trial results of this vaccine fully met the preset goals.

Yuxi WALVAX received the Phase III clinical trial approval for this vaccine issued by the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan Republik Indonesia, "BPOM") in September 2023. This clinical trial was designed as a randomized, blind, positive-controlled study, with the study population consisting of healthy infants aged 6-8 weeks in Indonesia. It evaluated the immunogenicity and safety of administering this vaccine or a control vaccine using the "2p+1" immunization program, in conjunction with some routine vaccines from the local Expanded Programme on Immunization (EPI). The receipt of the "2p+1" immunization program Phase III clinical trial report marks the successful completion of the overseas Phase III clinical research phase for this vaccine in Indonesia.

The research results from this clinical trial will provide clinical data support for the application of this vaccine in different immunization programs and combination vaccination scenarios, and will serve as a basis for its registration application, integration into routine immunization programs, and optimization of immunization strategies. This will further enhance the vaccination flexibility of this vaccine in overseas markets, improve market competitiveness, and is of significant importance for the company in addressing public health issues in developing countries

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