Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for a Phase II study in locally advanced or metastatic non-small cell lung cancer (NSCLC), is now cleared for evaluation in additional advanced cancers including gastric, small cell lung, triple negative breast, urothelial carcinoma, esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma, and nasopharyngeal carcinoma (NPC).
BL-B01D1, which targets EGFR and HER3, has demonstrated promising therapeutic potential across multiple epithelial tumor types, particularly in patients with various lung cancers, nasopharyngeal cancer, ESCC, and breast cancer. The ADC is currently in Phase III clinical trials for end-line NPC, an indication for which it received breakthrough therapy designation (BTD) in China last month, and for second-line ESCC. In a significant deal at the end of 2023, Biokin entered into a USD 8.4 billion licensing agreement with US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) for the joint development and commercialization of BL-B01D1 in the US.- Flcube.com
