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上海复星医药(集团)股份有限公司关于控股子公司获美国FDA药品临床试验批准的公告
Shang Hai Zheng Quan Bao·2025-08-07 19:06

Group 1 - The core point of the announcement is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd.'s subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct Phase I clinical trials for the new drug HLX43, which is a targeted PD-L1 antibody-drug conjugate for the treatment of thymic carcinoma [2][3] - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [3] - As of June 2025, the cumulative R&D investment for this new drug by the group is approximately RMB 182 million (unaudited) [3] Group 2 - There are currently no approved PD-L1 targeted antibody-drug conjugates available in the global market [4]