上海医药集团股份有限公司关于B023细胞注射液获得临床试验批准通知书的公告

Group 1 - The core project is the B023 cell injection, which has received approval for clinical trials from the National Medical Products Administration (NMPA) for treating inoperable, locally advanced, or metastatic solid tumors that have failed standard treatments [1][2] - B023 is an innovative Class I biological product developed by Shanghai Pharmaceutical Group's subsidiary, with a total research and development investment of approximately 39.26 million RMB [2] - The active component of B023 is invariant natural killer T (iNKT) cells, which can be used universally without causing graft-versus-host disease due to the lack of polymorphism in CD1d among the population [2] Group 2 - As of the announcement date, there are no other drugs with the same indication and type available in the global market [3] - The approval for clinical trials does not significantly impact the company's current operations, and the company will continue to advance the project in accordance with national regulations [3]