Luzhu Biotech’s Core Product BLA Application Accepted by China’s National Medical Products Administration
February 11, 2025
Source: drugdu
26
Luzhu Biotech-B (02480) announced that the Biologics License Application (BLA) for its core product, LZ901, has recently been accepted by the National Medical Products Administration (NMPA) of the People's Republic of China. This milestone marks a significant step forward in the company's development of a recombinant shingles vaccine (CHO cell). LZ901 is designed to prevent shingles and related complications, including postherpetic neuralgia, in adults aged 40 and above. The vaccine successfully achieved its predefined objectives and delivered expected clinical results in Phase III clinical trials in China.
According to the announcement, after the BLA acceptance, the NMPA will conduct technical reviews, clinical trial site inspections, and manufacturing site inspections to assess the feasibility of the application. However, it is important to note that despite the smooth progress of LZ901's development, the company cannot guarantee the product's eventual success in development and commercialization. Shareholders and potential investors are advised to exercise caution when trading the company's shares.
https://finance.eastmoney.com/a/202502093314223646.html
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