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复星医药(02196.HK):控股子公司获美国FDA药品临床试验批准
Ge Long Hui A P P·2025-08-07 10:53

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate, for the treatment of thymic carcinoma [1] - Fuhong Hanlin plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] Group 2: Drug Development and Investment - HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain with a self-developed targeted PD-L1 antibody, aimed at treating advanced/metastatic solid tumors [1] - As of June 2025, the cumulative R&D investment for this drug is approximately RMB 182 million (unaudited, single drug) [1] - Currently, there are no approved PD-L1 targeted antibody-drug conjugates available globally [1]