Core Insights - WuXi AppTec's subsidiary, WuXi Biologics, has received formal acceptance from the National Medical Products Administration (NMPA) for its supplemental application for the post-marketing use of its domestically produced viral vector, JWLV011, for the production of its CAR-T therapy, Ruili Kelong [1][2] Group 1: Product Development - The application is based on a Phase II single-arm study aimed at evaluating the comparability of Ruili Kelong produced with the new viral vector JWLV011 against that produced with existing viral vectors [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] Group 2: Safety and Efficacy - The most common severe adverse event reported was cytopenia, with CAR-T related toxicities such as cytokine release syndrome (CRS) primarily at grade 1, and no occurrences of grade 3 or higher CRS or any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) [2] - Clinical data indicates that the Ruili Kelong produced with the domestically sourced JWLV011 is clinically comparable to that produced with existing viral vectors [2] Group 3: Strategic Importance - The chairman and CEO of WuXi AppTec emphasized that the domestically produced viral vector is not only a crucial raw material for cell therapy products but also the most expensive, making its domestic substitution strategically significant for the company [2] - Successful completion of the viral vector substitution is expected to stabilize supply for commercial products and clinical development while significantly reducing costs, enhancing the company's competitive position in commercialization and insurance negotiations [2]
药明巨诺-B(02126.HK)：中国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