SINO BIOPHARM (01177): The "CLDN18.2 ADC" phase III clinical trial of Vitacotuzumab Bebetocin has completed subject enrollment.

SINO BIOPHARM (01177) announced that its wholly-owned subsidiary, Regal New Medicine Technology (Shanghai) Co., Ltd. (Regal Medicine), has independently developed a Class 1 innovative drug, V2K, monoclonal antibody (research code: LM-302) "CLDN18.2 ADC" for the treatment of locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma with third-line or above CLDN18.2 positive has successfully completed patient enrollment for a Phase III registration clinical trial (LM302-03-101). LM302 is the world's first CLDN18.2 ADC drug to complete Phase III clinical trial enrollment. LM-302 is a targeted antibody-drug conjugate (ADC) that binds specifically to CLDN18.2 positive tumor cells and releases small molecule toxins into the cells via endocytosis, achieving precise killing of tumor cells. As a potential First-In-Class (FIC) drug, LM-302 has shown promising clinical development potential in a variety of digestive tract tumors such as gastric cancer, pancreatic cancer, and biliary tract cancer, and is expected to provide new treatment options for patients with low CLDN18.2 expression and low PD-L1 expression. At the 2025 annual meeting of the American Society of Clinical Oncology (ASCO), Regal Medicine announced the latest research data on LM-302 in combination with trastuzumab 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%. Among the 32 patients with CLDN18.2 expression 25%, the ORR reached 71.9%, and the DCR reached 96.9%. Stratified analysis based on PD-L1 expression showed that ORR was 63.3% in patients with PD-L1 CPS <1, and 77.8% in patients with CPS 1. The study demonstrated that the LM302 combined treatment regimen exhibited significant anti-tumor activity and manageable safety profile in CLDN18.2 positive patients. In addition to the ongoing Phase III registration study for locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma with third-line or above CLDN18.2 positive, LM-302 is planning another Phase III registration clinical trial in China in combination with PD-1 monoclonal antibody for the treatment of first-line locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, further expanding its therapeutic potential in the field of gastric cancer. Furthermore, several indications of LM302 have been included in the Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration and have received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA). Leveraging the strong support of the group's resources and industrialization capabilities, Regal Medicine is accelerating the clinical transformation and commercialization of more innovative drugs, committed to bringing more accessible treatment hope to cancer patients worldwide.