Core Viewpoint - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the NMPA for a supplemental application to use domestically produced viral vectors for the production of its CAR-T therapy, Breyanzi, which aims to enhance supply stability and reduce costs [1][2]. Group 1: Product Development - The new application is based on a Phase II single-arm study that evaluates the comparability of Breyanzi produced with the new viral vector (JWLV011) against that produced with existing viral vectors [2]. - The study has shown a 3-month objective response rate (ORR) of 66.67% and a complete response (CR) rate of 41.67% [2]. Group 2: Safety and Efficacy - The most common severe adverse event reported was cytopenia, with CAR-T related toxicities primarily being grade 1, and no grade 3 or higher cytokine release syndrome (CRS) or any level of immune effector cell-associated neurotoxicity syndrome (ICANS) observed [2]. - Clinical data indicates that the Breyanzi produced with the domestically sourced viral vector (JWLV011) is clinically comparable to that produced with existing viral vectors [2]. Group 3: Strategic Importance - The CEO of WuXi Biologics emphasized that the domestic production of viral vectors is strategically significant, as it will stabilize supply and significantly reduce production costs [2]. - Lower costs will enhance the company's competitive position in commercialization and insurance negotiations, potentially leading to a substantial increase in the commercial value of Breyanzi [2].
药明巨诺-B：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