智通财经网·2026-02-08 22:23Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its innovative drug, LM-302, targeting CLDN18.2 positive advanced gastric and gastroesophageal junction adenocarcinoma, marking it as the first CLDN18.2 ADC drug to complete patient enrollment in a Phase III trial [1][2]. Group 1 - LM-302 is an antibody-drug conjugate (ADC) that specifically targets CLDN18.2 positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The drug shows promising clinical development potential in various gastrointestinal tumors, including gastric cancer, pancreatic cancer, and cholangiocarcinoma, and aims to provide new treatment options for patients with low CLDN18.2 and PD-L1 expression [1][2]. - At the 2025 ASCO annual meeting, Lixin Pharmaceutical reported an objective response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients, with even higher rates in patients with CLDN18.2 expression ≥25% [2]. Group 2 - In addition to the ongoing Phase III study for advanced gastric cancer, LM-302 is set to undergo another Phase III trial in China, combining it with PD-1 monoclonal antibodies for first-line treatment of CLDN18.2 positive advanced gastric cancer [2]. - Multiple indications for LM-302 have been designated as breakthrough therapies by the China National Medical Products Administration (NMPA) and have received orphan drug designation from the U.S. FDA [2]. - Lixin Pharmaceutical is accelerating the clinical transformation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].