Zhi Tong Cai Jing·2025-08-19 08:47Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed the innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] Group 1: Drug Development and Clinical Trials - LM-302 is a first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2, showing clinical efficacy in patients with gastric cancer, pancreatic cancer, and biliary tract cancer [1] - The latest research data presented at the 2025 ASCO annual meeting indicates an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients [1] - In patients with CLDN18.2 expression ≥25%, the ORR was 71.9% and the DCR was 96.9%, demonstrating good anti-tumor activity and controllable safety in CLDN18.2 positive patients [1] Group 2: Regulatory and Market Implications - LM-302 is currently undergoing Phase III clinical trials in China for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on second-line or higher systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to accelerate the market entry of LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]