Core Viewpoint - The stock of药捷安康-B (02617) has surged over 18%, reaching a new high of 129.3 HKD, with a market capitalization exceeding 50 billion HKD, driven by positive clinical trial news for its core product, Tinengotinib [1] Company Developments -药捷安康 announced that its core product, Tinengotinib (TT-00420), in combination with Fulvestrant, has received clinical implied approval from the National Medical Products Administration (NMPA) in China for a Phase II trial targeting hormone receptor-positive (HR+) and HER2-negative or low-expressing recurrent or metastatic breast cancer, with the trial set to commence on September 10, 2025 [1] - The company highlighted that Tinengotinib targets FGFR/VEGFR, JAK, and Aurora, and currently, no other MTK inhibitors possess the same targeted combination, showcasing its unique value in treating certain diseases [1] Regulatory Approvals - Tinengotinib has been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA and has received fast track designation from the FDA for both cholangiocarcinoma and metastatic castration-resistant prostate cancer [1] - Additionally, the FDA has granted orphan drug designation for cholangiocarcinoma and the European Medicines Agency (EMA) has also awarded orphan drug status for cholangiocarcinoma treatment [1]
药捷安康-B再涨超18% 总市值突破500亿港元 替恩戈替尼乳癌II期试验获批