Core Insights - 康哲药业's innovative drug Y-3 for treating acute ischemic stroke has received acceptance for its New Drug Application (NDA) by the NMPA in China [1] - Y-3 is the world's first brain cell protector targeting critical pathological processes in stroke, showing significant clinical benefits and good safety in Phase III trials [1][2] - The market potential for Y-3 is substantial, given the high incidence of stroke in China and the associated complications like post-stroke depression and anxiety [2] Company Developments - 康哲药业 has established a strong product portfolio in the central nervous system area, enhancing its market foundation [2] - The company has signed a permanent exclusive promotion agreement for Y-3 with Nanjing Ningdan New Drug Technology Co., expanding its market reach in mainland China and Hong Kong [3] Industry Context - China accounts for approximately one-third of global new stroke cases, with ischemic strokes making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past 30 years, compounded by an aging population, which poses significant challenges for stroke prevention and management [2] - Post-stroke depression and anxiety affect around 30% and 25% of stroke patients, respectively, impacting recovery and increasing mortality risk [2]
康哲药业(00867)脑卒中治疗领域重磅创新药注射用Y-3中国NDA获受理