SINO BIOPHARM (01177.HK): NDA for CLDN18.2 ADC Tecotabart Vedotin Accepted for Gastric Cancer Treatment
NewTimeSpace News: Sino Biopharmaceutical Limited (01177.HK) announced on 23 June that the New Drug Application (NDA) for its CLDN18.2 ADC innovative drug Tecotabart Vedotin has been accepted by authorities for third-line and above gastric cancer treatment and has been granted priority review. The drug can precisely target CLDN18.2-positive tumors and exert bystander killing effect, with synergistic anti-tumor efficacy when combined with PD-1 antibody. Approximately 970,000 new gastric cancer cases are diagnosed globally each year, over one third of which occur in China, and CLDN18.2 represents a popular therapeutic target. A Phase III clinical trial of the ADC combined with PD-1 antibody for first-line treatment is also underway.
NewTimeSpace News: On 23 June 2026, Sino Biopharmaceutical Limited (01177.HK) released a voluntary announcement stating that Tecotabart Vedotin (CLDN18.2 ADC, research code LM-302), an innovative drug independently developed by LaNova Medicines Limited, the Group’s wholly-owned subsidiary, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration and obtained acceptance. It is indicated for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positivity that has received at least two lines of systemic therapy. This indication was included in the priority review and approval procedure on 22 May 2026.
LM-302 is an antibody-drug conjugate (ADC) targeting CLDN18.2, composed of a recombinant humanized monoclonal antibody conjugated with monomethyl auristatin E (MMAE). It can accurately recognize CLDN18.2-positive tumor cells. The conjugated MMAE exerts a "bystander effect" to kill surrounding tumor cells with low target expression and induces immunogenic cell death, generating synergistic anti-tumor activity when combined with PD-1 monoclonal antibody. The current NDA submission is supported by positive pivotal Phase III clinical trial results, and the interim analysis has met the two primary study endpoints.
Gastric cancer is a highly prevalent malignant tumor worldwide. Around 970,000 new cases were recorded globally in 2022, more than one third of which were from China, and the median overall survival of advanced patients is less than 10 months. CLDN18.2 is moderately to highly expressed in 31%–86% of gastric/gastroesophageal junction cancers (GC/GEJ). A Phase III clinical trial evaluating LM-302 in combination with PD-1 antibody for first-line treatment is also ongoing. Both indications have been granted Breakthrough Therapy Designation by CDE.
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