Core Viewpoint - Kangzheng Pharmaceutical announced that its new drug Y-3 for injection has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) in China, aimed at treating acute ischemic stroke and potentially preventing post-stroke depression and anxiety [1] Group 1: Product Development and Clinical Trials - Y-3 is the first brain cell protector developed based on key targets in the pathological process of stroke, specifically targeting PSD95-nNOS and MPO, which may enhance its protective effects on brain cells [1][2] - The Phase III clinical trial involved nearly 1,000 acute ischemic stroke patients and demonstrated significant clinical benefits and good overall safety, with results expected to be published in international academic journals [1][2] Group 2: Market Context and Demand - Approximately 3.94 million new stroke cases occur annually in China, with ischemic strokes accounting for about 72%, indicating a significant market need for effective treatments [3] - The burden of stroke-related disabilities has increased over the past 30 years, compounded by an aging population, which poses challenges for patients and society [3] Group 3: Strategic Partnerships and Market Position - The company has signed a permanent exclusive promotion agreement for Y-3 with Nanjing Ningdan New Drug Technology Co., Ltd., enhancing its market presence in mainland China, Hong Kong, and Macau [3] - Y-3's addition to the company's CNS portfolio will strengthen its innovative pipeline and synergize with existing products, potentially leading to improved treatment options for ischemic stroke patients [4]

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]