NMPA accepts Tecotabart Vedotin NDA for third-line CLDN18.2+ Gastric cancer

CAR-T Digest - August 2020

Weekly Digest - June 2026

23 June 2026: NMPA accepts Tecotabart Vedotin NDA for third-line CLDN18.2+ Gastric cancer

The NDA for LM-302, a CLDN18.2-targeting antibody-drug conjugate developed by Sino Biopharmaceutical, has been accepted by China’s NMPA for the treatment of CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies, with the application already granted Priority Review status
The submission is supported by positive results from a pivotal phase 3 study evaluating LM-302 monotherapy in previously treated CLDN18.2-positive advanced GC/GEJ patients, where the trial achieved both pre-specified primary endpoints at interim analysis, paving the way for a potential first regulatory approval of the asset
The filing addresses a significant unmet need in advanced gastric cancer, where treatment options remain limited following progression on prior therapies and median overall survival remains poor, particularly in heavily pretreated patients
LM-302 is a CLDN18.2-targeted ADC comprising a humanized monoclonal antibody linked to the microtubule inhibitor MMAE. Beyond selectively targeting CLDN18.2-expressing tumor cells, the ADC is designed to leverage MMAE-mediated bystander killing and induce immunogenic cell death, providing a strong mechanistic rationale for combination strategies with PD-1 inhibitors
Strategically, the NDA acceptance positions LM-302 to potentially become the first approved CLDN18.2-targeted ADC globally, strengthening MediLink’s leadership in the rapidly evolving CLDN18.2 landscape while expanding Bristol Myers Squibb’s presence in gastrointestinal oncology and validating ADC-based approaches beyond HER2-directed gastric cancer therapies