Group 1 - The core point of the news is that Kangzheng Pharmaceutical has received acceptance for the New Drug Application (NDA) of its innovative drug Y-3 for the treatment of acute ischemic stroke by the National Medical Products Administration (NMPA) in China [1] - Y-3 is the world's first brain cell protector developed based on key pathological targets PSD95-nNOS and MPO, which acts on multiple critical pathological processes of ischemic stroke [1] - The Phase III clinical study of Y-3 in China has achieved its primary efficacy endpoint, showing significant clinical benefits for patients and good overall safety [1] Group 2 - In China, approximately 3.94 million new stroke cases occur annually, accounting for one-third of global new cases, with ischemic stroke making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past thirty years, compounded by an aging population, leading to greater challenges for stroke prevention and control [2] - Post-stroke depression and anxiety are common complications, with incidence rates of about 30% and 25%, respectively, which can affect neurological recovery and increase mortality risk [2] Group 3 - Kangzheng Pharmaceutical has established a deep product layout in the central nervous system field, which is one of its core strengths [2] - If Y-3 is approved, it will synergize with existing innovative drugs such as Vitoqu (for cluster epilepsy) and the original brand drug Dailixin (for anxiety and depression), as well as the modified new drug ZUNVEYL (for Alzheimer's disease) under NDA review [2] - The company aims to leverage its excellent commercialization experience and efficient operational system to accelerate the availability of innovative therapies for more patients [2][3]
康哲药业脑卒中治疗领域重磅创新药注射用Y-3中国NDA获受理