Sino Biopharmaceuticals CLDN18.2 ADC LM-302 granted Priority Review with China approval expected

CAR-T Digest - August 2020

Weekly Digest - May 2026

25 May 2026: Sino Biopharmaceuticals CLDN18.2 ADC LM-302 granted Priority Review with China approval expected

Sino Biopharmaceuticals CLDN18.2-targeted ADC LM-302 has entered China’s priority review pathway, positioning the asset for a potential regulatory approval in previously treated advanced or metastatic gastric and gastroesophageal junction adenocarcinoma and intensifying competition within the rapidly evolving CLDN18.2 treatment landscape
Clinical studies have demonstrated encouraging anti-tumor activity for LM-302 in advanced gastric cancer, with meaningful response rates and disease control alongside a manageable safety profile, supporting its potential as a differentiated targeted therapy in a setting with substantial unmet need
LM-302 is a CLDN18.2-directed ADC conjugated with an MMAE payload, designed to selectively target tumor cells while also generating a bystander killing effect, highlighting the growing therapeutic potential of CLDN18.2-targeted ADCs in gastrointestinal malignancies
Emerging combination data, including LM-302 with PD-1 inhibitors, suggests the potential for chemotherapy-sparing treatment approaches, reflecting a broader industry trend toward integrating ADCs with immunotherapy to improve frontline outcomes while reducing treatment burden
Strategically, the initiation of a global Phase 3 chemotherapy-free first-line study evaluating LM-302 plus PD-1 therapy signals Sino’s ambition to move beyond the relapsed/refractory setting and establish a differentiated position in frontline CLDN18.2-positive gastric cancer, a market currently attracting significant investment and competitive activity