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]

Core Viewpoint - The announcement highlights the acceptance of the New Drug Application (NDA) for the injection Y-3, a novel drug aimed at protecting brain cells in acute ischemic stroke patients, by the National Medical Products Administration (NMPA) of China on December 11, 2025 [1] Group 1: Product Development and Clinical Trials - Injection Y-3 is the first brain cell protector developed based on critical targets in the pathological process of stroke, specifically targeting PSD95-nNOS and MPO [1] - The Phase III clinical trial involved nearly 1,000 acute ischemic stroke patients and demonstrated significant clinical benefits and good overall safety [1] - The main efficacy results of the Phase III clinical trial are planned to be presented at international academic conferences and published in international academic journals [1] Group 2: Market Need and Potential - Approximately 3.94 million new stroke cases occur annually in China, accounting for one-third of global new cases, with ischemic stroke making up about 72% of these cases [3] - The burden of stroke-related disabilities has been increasing over the past 30 years, compounded by an aging population, leading to greater challenges in stroke prevention and control [3] - Post-stroke depression and anxiety are common complications, affecting about 30% and 25% of patients respectively, which can hinder recovery and increase mortality risk [3] Group 3: Strategic Partnerships and Market Position - The company has signed a permanent exclusive promotion agreement for injection Y-3 in mainland China, Hong Kong, and Macau with Nanjing Ningdan New Drug Technology Co., Ltd. [3] - The addition of injection Y-3 will enhance the company's differentiated innovation pipeline in the central nervous system (CNS) field, complementing existing products and those under NDA review [4] - Successful commercialization of injection Y-3 is expected to provide new treatment options for ischemic stroke patients, meeting clinical demands for effective and safe medications, and positively impacting the company's performance [4]