Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with or without chemotherapy, in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
BL-B01D1, which targets EGFR and HER3, has demonstrated a robust therapeutic profile across a variety of epithelial tumor types. It has shown particular promise in non-small cell lung cancer, small-cell lung cancer, nasopharyngeal cancer, esophageal squamous cell carcinoma (ESCC), and breast cancer. The drug is currently in Phase III clinical trials for end-line nasopharyngeal carcinoma (NPC), for which it was granted breakthrough therapy designation (BTD) in China in the last week, and for second-line ESCC.
In a significant move 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). The deal facilitates the joint development and commercialization of BL-B01D1 in the U.S. market, underscoring the global potential of this novel ADC.- Flcube.com
