huahaipharm(SH:600521) Ge Long Hui A P P·2025-12-26 09:23Core Viewpoint - The company, Huahai Pharmaceutical, has announced the initiation of Phase III clinical trials for HB0025, a novel PD-L1/VEGF dual-specific fusion protein aimed at treating squamous and non-squamous non-small cell lung cancer [1][2]. Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration [1]. - HB0025 is designed to target both PD-L1 and VEGF pathways, enhancing anti-tumor mechanisms through dual action on immune evasion and tumor angiogenesis [1][2]. - The Phase III trials will include two confirmatory studies, which are expected to provide new first-line treatment options for advanced non-small cell lung cancer patients, regardless of PD-L1 expression levels [2]. Group 2: Competitive Landscape - Currently, other PD-1/VEGF dual antibodies, such as Ivosidenib by Kangfang Biotech and PM8002 by BMS, have entered clinical Phase III, indicating a competitive market for dual-target therapies [2]. - The promising Phase II clinical data for HB0025, presented at the 2025 ESMO conference, showed good objective response rates and disease control rates, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 32.597 million in the research and development of the HB0025 project to date [3].