Sino Biopharmaceutical Limited (1177) announced that tecotabart vedotin (LM-302), an innovative “CLDN18.2 ADC” drug independently developed by its wholly owned subsidiary, LaNova Medicines, has completed patient enrollment in a Phase III registrational clinical trial for third-line and later CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. According to the announcement, LM-302 is the world’s first CLDN18.2 antibody-drug conjugate to achieve this milestone.
Tecotabart vedotin targets CLDN18.2-positive tumor cells and releases a small molecule cytotoxic payload upon internalization, enabling targeted tumor cell killing. Data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting showed an overall response rate of 65.9% and a disease control rate of 85.4% among 41 efficacy-evaluable patients who received LM-302 in combination with toripalimab for gastric cancer. Among 32 patients with CLDN18.2 expression ≥25%, the overall response rate reached 71.9%, and the disease control rate was 96.9%. These results indicated promising anti-tumor activity and a manageable safety profile.
In addition to the ongoing Phase III study in third-line and later treatment, the company plans to initiate another Phase III registrational trial in China, combining tecotabart vedotin with a PD-1 monoclonal antibody for the first-line treatment of locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Multiple indications of LM-302 have been granted Breakthrough Therapy Designation by the National Medical Products Administration of China, and the drug has also obtained Orphan Drug Designation from the United States Food and Drug Administration.
According to the announcement, Sino Biopharmaceutical Limited aims to leverage its resources and industrial capabilities to accelerate the clinical translation and commercialization of innovative therapies, with the goal of providing accessible treatment options for cancer patients worldwide.