SINO BIOPHARM (01177) announced that its wholly-owned subsidiary, Linnovation Pharma Tech (Shanghai) Co., Ltd., has successfully completed patient enrollment for the Phase III registrational clinical trial (LM302-03-101) of its self-developed Class 1 innovative drug, Claudiximab (R&D code: LM-302), a "CLDN18.2 ADC". The trial is evaluating the drug for the treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2 positive in the third-line and above setting. LM-302 is the first CLDN18.2 ADC drug globally to complete enrollment for a registrational 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, being internalized into the cells, and then releasing a potent small-molecule toxin. As a potential first-in-class (FIC) drug, LM-302 has demonstrated promising clinical development potential in various gastrointestinal tumors, including gastric, pancreatic, and biliary tract cancers. It is also expected to provide a new treatment option for patients with low CLDN18.2 expression and low PD-L1 expression.

At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Linnovation Pharma presented updated research data on LM-302 in combination with toripalimab for gastric cancer. Among 41 efficacy-evaluable patients, the objective response rate (ORR) was 65.9%, and the disease control rate (DCR) was 85.4%. Specifically, in the 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR reached 96.9%. Analysis stratified 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 PD-L1 CPS≥1. This study indicates that the LM-302 combination regimen exhibits significant anti-tumor activity and a manageable safety profile in CLDN18.2-positive patients.

Beyond the ongoing Phase III registrational study in the third-line and above setting, LM-302 is planned to commence another Phase III registrational clinical trial in China. This trial will evaluate the drug in combination with a PD-1 inhibitor for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, further expanding its therapeutic potential in gastric cancer.

Furthermore, multiple indications for LM-302 have been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and have received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA).

Leveraging the strong resource support and industrial capabilities of the group, Linnovation Pharma is accelerating the clinical translation and commercialization process of more innovative drugs, committed to bringing more accessible treatment hope to cancer patients worldwide.