Core Viewpoint - Kangzheng Pharmaceutical's new drug application for Y-3 has been officially accepted by the National Medical Products Administration, targeting acute ischemic stroke treatment and potentially preventing post-stroke depression and anxiety symptoms [1][2] Group 1: Product Development - Y-3 is the world's first multi-target neuroprotective agent aimed at PSD95-nNOS and MPO, showing promising efficacy in treating ischemic stroke [1] - The company has established a strong presence in the central nervous system field, with a product portfolio that includes the marketed innovative drug Vituco and the original brand drug Dailixin, along with the NDA-reviewed modified new drug ZUNVEYL [1] Group 2: Clinical Research and Impact - The burden of stroke-related disabilities has increased over the past thirty years, with post-stroke depression and anxiety affecting approximately 30% and 25% of patients, respectively [2] - Y-3 has reached its primary efficacy endpoint in Phase III clinical trials in China, demonstrating significant clinical benefits and good overall safety [2] - The main research results for Y-3 are planned to be presented at international academic conferences, with the overall study set to be published in international academic journals [2]

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]

Core Viewpoint - The announcement by Kangzheng Pharmaceutical regarding 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, highlights its potential as a groundbreaking treatment option in the market [1] Group 1: Product Development and Clinical Trials - Injection Y-3 is the first brain cell protector developed based on critical targets in the pathology of stroke, specifically PSD95-nNOS and MPO, and aims to address multiple key pathological processes in ischemic stroke [1][2] - The Phase III clinical trial for injection Y-3 involved nearly 1,000 acute ischemic stroke patients and demonstrated significant clinical benefits and good overall safety [1] - The main research results from the clinical trial are planned to be presented at international academic conferences and published in international academic journals [1] Group 2: Market Context and Demand - According to the National Health Commission, approximately 3.94 million new stroke cases occur annually in China, with ischemic stroke accounting for about 72% of these cases, indicating a significant market need for effective treatments [3] - The burden of stroke-related disabilities has been increasing over the past 30 years, compounded by an aging population, which poses greater challenges for 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 worsen prognosis, underscoring the potential value of injection Y-3 in improving long-term neurological function and overall outcomes for stroke patients [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., a company focused on clinical needs and innovation [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] - The successful commercialization of injection Y-3 is expected to provide new treatment options for patients with ischemic stroke, meeting clinical demands for effective and safe medications, and positively impacting the company's performance [4]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 自願性及業務進展公告 抗急性缺血性卒中1類新藥注射用Y-3中國上市許可申請已獲受理 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，1類新藥注射用Y-3（擬定中文通用名：注射用洛貝米柳）（「注射用Y-3」或 「產品」）新藥上市許可申請（NDA）已於二零二五年十二月十一日獲得中國國家藥品 監督管理局（NMPA）受理。產品為一種擬用於急性缺血性卒中的腦細胞保護劑。 中樞神經系統（CNS）是本集團核心優勢領域之一，已逐步形成深度佈局。注射用Y-3 的加入，將進一步豐富及優化本集團CNS領域的差異化創新管線，並與在售產品維圖可 （地西泮鼻噴霧劑）、黛力新（氟哌噻噸美利曲辛片）以及處於NDA評審階段的改良型 新藥ZUNVEYL（葡萄糖酸苯加蘭他敏腸溶片）等系列CNS品種在專家網絡與市場資源 方面形成有力協同。憑藉本集團成功的商業化經驗、 ...

Core Viewpoint - 康哲药业's new drug ZUNVEYL has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) in China, aimed at treating mild to moderate Alzheimer's disease symptoms [1] Group 1: Product Details - ZUNVEYL is a new generation acetylcholinesterase inhibitor (AChEI) that improves cognitive and memory functions in Alzheimer's patients by increasing central acetylcholine levels [2] - The drug is a prodrug of galantamine, designed to reduce gastrointestinal side effects and improve patient tolerance, with recorded gastrointestinal adverse events below 2% [2] - ZUNVEYL is the second oral therapy for Alzheimer's approved by the FDA in the last decade, potentially enhancing medication adherence among patients [2] Group 2: Market Context - Alzheimer's disease is a chronic neurodegenerative condition, with Alzheimer's-type dementia accounting for 50% to 70% of all dementia cases, affecting approximately 9.83 million patients in China [3] - The increasing aging population is expected to raise the number of Alzheimer's patients, intensifying the disease burden [3] - Current Alzheimer's medications primarily focus on improving cognitive symptoms, with a significant demand for safer treatment options due to high side effect rates of existing drugs [3] Group 3: Strategic Partnerships - 康哲药业 has signed a licensing and collaboration agreement with Alpha Cognition Inc. for ZUNVEYL, granting exclusive rights for development and commercialization in Asia (excluding Japan and the Middle East), Australia, and New Zealand [4] - The agreement is set for an initial term of twenty years, with automatic five-year extensions unless terminated by either party [4] - ZUNVEYL is expected to diversify 康哲药业's innovative drug portfolio and enhance its competitive strength in the market, potentially benefiting the company's performance upon approval [4]