Zhi Tong Cai Jing·2025-08-19 08:53Core Insights - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed an innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) in China for the treatment of CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] - 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, including those with low expression of Claudin 18.2 and PD-L1 [1] - Recent data presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicated an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients, with ORR of 71.9% and DCR of 96.9% in 32 patients with CLDN18.2 expression ≥25% [1] Clinical Development - LM-302 is currently undergoing Phase III clinical trials in China for the treatment of CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on two or more lines of systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to accelerate the approval process for LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]