Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate for the treatment of thymic epithelial tumors (TETs) [1][2]. Group 1: Product Development - HLX43 is a novel targeted PD-L1 antibody-drug conjugate developed by the company, combining a small molecule toxin-peptide linker with a self-developed PD-L1 targeting antibody [1]. - The drug is intended for the treatment of advanced/metastatic solid tumors, particularly in patients with non-small cell lung cancer (NSCLC) who have failed prior checkpoint inhibitors and chemotherapy [2]. Group 2: Clinical Data - Phase 1 clinical trial data presented at the 2025 World Lung Cancer Conference (WCLC) showed HLX43 has a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in advanced solid tumors, especially in post-line resistant NSCLC patients [2]. - Preliminary efficacy was also encouraging in patients with thymic squamous cell carcinoma (TSCC) as reported at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [2]. Group 3: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity post-approval [2]. - If another drug for the same indication is approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3].
复宏汉霖(02696)：注射用HLX43用于胸腺上皮肿瘤治疗获美国食品药品管理局授予孤儿药资格认定