Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal carcinoma (NPC).
BL-B01D1, which targets EGFR and HER3, has demonstrated a robust therapeutic profile across various epithelial tumor types, showing particular efficacy in patients with non-small cell lung cancer, small-cell lung cancer, nasopharyngeal cancer, esophageal squamous cell carcinoma (ESCC), and breast cancer. The drug is currently undergoing Phase III clinical trials for end-line NPC and second-line ESCC.
In a significant development at the end of 2023, Biokin entered into an $8.4 billion licensing agreement with U.S. pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) for the joint development and commercialization of BL-B01D1 in the U.S. Additionally, Biokin has recently initiated a Phase III clinical study for the drug in China, focusing on ESCC.- Flcube.com
