Sino Biopharm (01177) announced that LM Tech Pharm (Shanghai) Co., Ltd. (LM Tech Pharm), a wholly-owned subsidiary of the group, has independently developed an innovative national Class 1 drug, Viticobatuximab (research code: LM-302), a CLDN18.2 ADC, which is currently undergoing a Phase III pivotal clinical trial (LM302-03-101) for the treatment of third-line and above CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Patient enrollment has been successfully completed. Notably, LM302 is the world's first CLDN18.2 ADC drug to complete patient enrollment in a pivotal Phase III clinical trial.
According to a report by Zhitong Finance, Sino Biopharm (01177) announced that its wholly-owned subsidiary, Limin Pharmaceuticals (Shanghai) Co., Ltd. (Limin Pharma), has independently developed an innovative Class 1 national drug called Vitekocutumab (R&D code: LM-302), a CLDN18.2 ADC, which is currently undergoing a Phase III pivotal clinical trial (LM302-03-101) for the treatment of third-line or higher CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Patient enrollment has been successfully completed. Notably, LM302 is the world's first CLDN18.2 ADC drug to complete patient enrollment in a pivotal Phase III clinical trial.
LM-302 is an antibody-drug conjugate (ADC) targeting CLDN18.2. It achieves precise tumor cell killing by specifically binding to CLDN18.2-positive tumor cells, entering the cells via endocytosis, and releasing small-molecule toxins. As a potential first-in-class (FIC) drug, LM-302 demonstrates strong clinical development potential across multiple gastrointestinal tumors, including gastric cancer, pancreatic cancer, and biliary tract cancer. It is expected to offer new treatment options for patients with low CLDN18.2 expression and low PD-L1 expression.
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Limin Pharma presented the latest research data on LM-302 in combination with Toripalimab for the treatment of gastric cancer. Among 41 evaluable patients, the objective response rate (ORR) was 65.9%, and the disease control rate (DCR) was 85.4%. In the subgroup of 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9%, and the DCR reached 96.9%. Stratified analysis by PD-L1 expression showed an ORR of 63.3% in patients with PD-L1 CPS <1 and an ORR of 77.8% in patients with CPS ≥1. The study indicates that the LM-302 combination regimen demonstrates significant antitumor activity and manageable safety characteristics in CLDN18.2-positive patients.
In addition to the ongoing Phase III pivotal study for third-line or higher CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, LM-302 is planning another Phase III pivotal clinical trial in China in combination with a PD-1 monoclonal antibody for the treatment of first-line CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, further expanding its therapeutic potential in gastric cancer. Moreover, multiple indications for LM-302 have been granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA).
Leveraging the group's robust resource support and industrialization capabilities, Limin Pharma is accelerating the clinical translation and commercialization of more innovative drugs, striving to bring accessible treatment options to cancer patients worldwide.
