Core Viewpoint - Kangzheng Pharmaceutical's new drug application for Y-3 has been officially accepted by the National Medical Products Administration, targeting acute ischemic stroke treatment and potentially preventing post-stroke depression and anxiety symptoms [1][2] Group 1: Product Development - Y-3 is the world's first multi-target neuroprotective agent aimed at PSD95-nNOS and MPO, showing promising efficacy in treating ischemic stroke [1] - The company has established a strong presence in the central nervous system field, with a product portfolio that includes the marketed innovative drug Vituco and the original brand drug Dailixin, along with the NDA-reviewed modified new drug ZUNVEYL [1] Group 2: Clinical Research and Impact - The burden of stroke-related disabilities has increased over the past thirty years, with post-stroke depression and anxiety affecting approximately 30% and 25% of patients, respectively [2] - Y-3 has reached its primary efficacy endpoint in Phase III clinical trials in China, demonstrating significant clinical benefits and good overall safety [2] - The main research results for Y-3 are planned to be presented at international academic conferences, with the overall study set to be published in international academic journals [2]

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]