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]
康哲药业：抗急性缺血性卒中1类新药注射用Y-3中国上市许可申请已获受理