复宏汉霖：HLX37在晚期/转移性实体瘤患者中的1期临床研究于中国境内完成首例患者给药

Core Viewpoint - The company has initiated a Phase 1 clinical trial for HLX37, a dual-specific antibody targeting PD-L1 and VEGF, in patients with advanced/metastatic solid tumors, marking a significant step in its development pipeline [1][2]. Group 1: Clinical Trial Details - The Phase 1 clinical study of HLX37 has completed its first patient dosing in mainland China, excluding Hong Kong, Macau, and Taiwan [1]. - The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in advanced/metastatic solid tumor patients, consisting of two parts: 1a (dose escalation) and 1b (dose expansion) [1]. - In the 1a phase, single-agent treatment will explore six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg, administered every three weeks, while combination therapy will be assessed in advanced non-small cell lung cancer patients [1]. - The primary endpoint of the study is to assess the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) [1]. Group 2: Mechanism and Market Potential - HLX37 is designed to simultaneously target two pathways: blocking the PD-1/PD-L1 signaling pathway to restore T cell activity against tumors, and inhibiting VEGF to reduce tumor angiogenesis, potentially leading to synergistic anti-tumor effects [2]. - Preclinical studies have shown that HLX37 can inhibit tumor growth with a favorable safety profile, indicating its potential as a competitive treatment option [2]. - According to IQVIA MIDASTM, the global sales for dual-specific antibodies targeting PD-1/PD-L1 and VEGF are projected to reach approximately $920 million in 2024, with the first product expected to be approved in May 2024 [3].