复宏汉霖(02696)：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 in mainland China, marking a significant step in its development pipeline [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in advanced/metastatic solid tumor subjects, consisting of two parts: 1a (dose escalation) and 1b (dose expansion) [2]. - 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 assess different dosing regimens of HLX37 with pemetrexed or paclitaxel and carboplatin in advanced non-small cell lung cancer patients [2]. - 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) for both single-agent and combination therapies [2]. Group 2: Mechanism and Potential - HLX37 is a recombinant humanized dual-specific antibody that targets both PD-L1 and VEGF, aiming to treat advanced/metastatic solid tumors by blocking the PD-1/PD-L1 signaling pathway and inhibiting angiogenesis [3]. - The dual-target design may produce a synergistic anti-tumor effect and potentially reduce the risk of resistance, with preclinical studies indicating that HLX37 can inhibit tumor growth while demonstrating good safety profiles [3]. - The drug is expected to achieve regulatory approval from the National Medical Products Administration (NMPA) for its Phase 1 clinical trial in November 2025 [3]. Group 3: Market Potential - According to IQVIA MIDASTM, the global sales of dual-specific antibodies targeting PD-1/PD-L1 and VEGF are projected to reach approximately $920 million in 2024, with the first product in this category expected to be approved in May 2024 [4].