Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the National Medical Products Administration (NMPA) for a supplemental application to use domestically produced viral vectors in the production of its CAR-T therapy, Breyanzi (JWLV011) [1][2]. Group 1 - The application is based on a Phase II single-arm study aimed at evaluating the comparability of Breyanzi produced with the new viral vector (JWLV011) versus the existing viral vector [2]. - The study has completed at least three months of follow-up, showing an objective response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% [2]. - The most common severe adverse event reported was cytopenia, with no grade 3 or higher cytokine release syndrome (CRS) events and no immune effector cell-associated neurotoxicity syndrome (ICANS) reported [2]. Group 2 - The domestic production of the viral vector is strategically significant for the company, as it aims to stabilize supply and reduce costs, which are currently high due to reliance on foreign suppliers [1][2]. - The successful transition to domestic viral vectors is expected to enhance the commercial viability and clinical development of Breyanzi, allowing the company to better compete in the market and negotiate with insurers [2].
药明巨诺-B(02126)：国家药监局正式受理倍诺达®使用国产病毒载体的上市后补充申请