SINO BIOPHARM (01177) announced that LM-302 "CLDN18.2 ADC," an innovative drug independently developed by its wholly-owned subsidiary Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. (Lixin Pharmaceutical), has been included in the Breakthrough Therapy Drug (BTD) program by China's Center for Drug Evaluation (CDE) of the National Medical Products Administration. The drug is intended for first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody.

LM-302 is a potential first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2. Clinical efficacy has been observed in patients with gastric cancer, pancreatic cancer, and biliary tract cancer, with clinical benefits also seen in patients with low Claudin 18.2 expression and low PD-L1 expression.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Lixin Pharmaceutical presented the latest research data on LM-302 combined with PD-1 monoclonal antibody for gastric cancer treatment. Among 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4%. In 32 patients with CLDN18.2 ≥25%, the ORR was 71.9% and DCR was 96.9%. The study results demonstrated that the LM-302 combination regimen showed favorable anti-tumor activity with manageable safety profile in CLDN18.2-positive patients.

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 that has progressed after second-line or later systemic treatment.

The inclusion in the breakthrough therapy drug program is expected to accelerate LM-302's market approval process, bringing innovative treatment options to more CLDN18.2-positive gastric cancer patients at an earlier stage.