BL-M05D1 received BTD in China for previously treated advanced Gastric/GEJ cancer

CAR-T Digest - August 2020

28 September 2026: BL-M05D1 received BTD in China for previously treated advanced Gastric/GEJ cancer

Biokin Pharma announced that BL-M05D1, its Claudin18.2-directed ADC, has been included in China’s NMPA Breakthrough Therapy program for patients with CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma who have previously received first-line standard therapy
This marks the first China Breakthrough Therapy Designation for BL-M05D1, with the designation granted for the post-first-line setting; the program is currently being evaluated across three clinical trials in China and overseas, including a phase 3 study, a phase 1b study and a phase 1a study
The designation addresses an unmet need in advanced CLDN18.2-positive GC/GEJC after first-line treatment, where patients require additional treatment options following progression on standard therapy and CLDN18.2 has emerged as a clinically relevant target in gastric cancer
BL-M05D1 is an innovative Claudin18.2-targeting ADC developed on the same technology platform as Iza-bren, sharing Baili Tianheng’s proprietary “linker + toxin” platform for targeted delivery of the cytotoxic payload
Strategically, the BTD strengthens Biokin’s next-generation ADC pipeline beyond Iza-bren, while BL-M05D1’s randomized phase 3 study in previously treated CLDN18.2-positive GC/GEJC has already initiated enrollment, with the first patient dosed in June 2026