Core Viewpoint - Fosun Pharma's subsidiary, Hanhui, has received orphan drug designation from the US FDA for its investigational drug HLX43, a PD-L1 targeted antibody-drug conjugate for the treatment of thymic epithelial tumors (TETs) [1] Group 1: Drug Development - HLX43 is a novel antibody-drug conjugate (ADC) developed by linking a small molecule toxin-peptide chain with a self-developed PD-L1 targeted antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1] - As of the announcement date, HLX43 is in Phase I clinical trials in China, with the thymic carcinoma (TC) cohort being part of an international multicenter trial approved in the US and Japan [1] Group 2: Market Context - There are currently no approved PD-L1 targeted antibody-drug conjugates available in the global market [1]
复星医药:复宏汉霖在研药品HLX43获美国FDA孤儿药资格认定