华海药业：子公司 HB0025 注射液启动III期临床试验

Core Viewpoint - Company Huahai Pharmaceutical (600521.SH) has announced the initiation of Phase III clinical trials for HB0025, an innovative anti-PD-L1/VEGF bispecific fusion protein targeting 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 tumor immunity and inhibiting angiogenesis, thus providing a dual mechanism for cancer treatment [1][2]. - Two confirmatory Phase III clinical trials will be launched for HB0025 [1]. Group 2: Competitive Landscape - Competing products include Kangfang Biotech's Ivosidenib (PD-1/VEGF bispecific), BMS's PM8002 (PD-L1/VEGF bispecific), and Pfizer's SSGJ-707 (PD-1/VEGF bispecific), which are in various stages of clinical development [2]. - The promising Phase II clinical data for HB0025 presented at the 2025 ESMO conference indicates a good objective response rate and disease control rate, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 325.97 million in the development of the HB0025 project to date [3].