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康哲药业(00867.HK)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
Ge Long Hui· 2025-12-11 11:30
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]