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。 二零二五年八月，德鎂醫藥獲NMPA簽發的藥物臨床試驗批准通知書，同意開展 povorcitinib用於治療非節段型白癜風等適應症的臨床試驗。德鎂醫藥已啓動產品在中國 的臨床開發工作，並考慮擇機在中國推動其治療HS和結節性癢疹等皮膚相關疾病的臨 *僅供識別 1 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 納入突破性治療品種名單 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，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企 業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公司日期為二零二 ...

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]

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 - Kangzheng Pharmaceutical (00867.HK) has received acceptance for its New Drug Application (NDA) for the injection Y-3, a brain cell protective agent intended for acute ischemic stroke, from the National Medical Products Administration (NMPA) of China on December 11, 2025 [1] Group 1 - The product Y-3 is classified as a Class 1 new drug [1] - The intended use of Y-3 is for the protection of brain cells in cases of acute ischemic stroke [1] - The NDA acceptance marks a significant step in the product's development and potential market entry [1]

Core Insights - 康哲药业's innovative drug Y-3 for treating acute ischemic stroke has received acceptance for its New Drug Application (NDA) by the NMPA in China [1] - Y-3 is the world's first brain cell protector targeting critical pathological processes in stroke, showing significant clinical benefits and good safety in Phase III trials [1][2] - The market potential for Y-3 is substantial, given the high incidence of stroke in China and the associated complications like post-stroke depression and anxiety [2] Company Developments - 康哲药业 has established a strong product portfolio in the central nervous system area, enhancing its market foundation [2] - The company has signed a permanent exclusive promotion agreement for Y-3 with Nanjing Ningdan New Drug Technology Co., expanding its market reach in mainland China and Hong Kong [3] Industry Context - China accounts for approximately one-third of global new stroke cases, with ischemic strokes making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past 30 years, compounded by an aging population, which poses significant challenges for stroke prevention and management [2] - Post-stroke depression and anxiety affect around 30% and 25% of stroke patients, respectively, impacting recovery and increasing mortality risk [2]

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]

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 Insights - The "light medical beauty" market in China has rapidly penetrated modern life, with treatments like photon rejuvenation and water light needles becoming accessible during short breaks, reflecting a shift in consumer behavior and preferences [1][3][4] - The market has evolved significantly over the past decade, with a growing user base and increasing market transparency, leading to a projected user scale of 31.05 million by 2025 [1][2] - The industry is experiencing consolidation, with small institutions facing challenges due to increased competition from new players like New Oxygen and JD Health, indicating a trend towards chain operations and larger entities [2][12] Market Growth and Trends - The user scale of China's light medical beauty market reached 23.54 million in 2023, with expectations to grow to 31.05 million by 2025 [1] - The medical beauty market size is projected to increase from 227.4 billion yuan in 2021 to 364 billion yuan by 2025, with light medical beauty accounting for 53.3% of the market [1] - The consumer demographic has expanded from a niche market to a broader age range, including Z generation to individuals over 40, indicating a shift towards a more inclusive consumer base [5][12] Consumer Behavior and Preferences - There is a notable shift in consumer preferences from "internet celebrity faces" to more natural aesthetics, with 78% of consumers seeking natural results [4][5] - Male consumers are emerging as a significant growth segment, with their share in the medical beauty market increasing from 14% to 29% between 2022 and 2025 [5][6] - Consumers are increasingly prioritizing quality and personalized aesthetic design over mere procedural outcomes, reflecting a maturation in consumer awareness [4][10] Product and Service Evolution - The market has seen a shift in dominant products, with botulinum toxin and hyaluronic acid remaining the leading choices, while regenerative materials are gaining traction [6][7] - Regenerative materials, such as polylactic acid and recombinant collagen, are being introduced, but experts believe hyaluronic acid will maintain its dominant position due to its established safety and effectiveness [7][8] - The price of medical beauty services is becoming more transparent, with significant reductions in costs for treatments like photon rejuvenation, making them more accessible to a wider audience [10][11] Industry Dynamics and Future Outlook - The medical beauty industry is undergoing significant restructuring, with a high turnover rate of institutions and a trend towards professional consolidation [12][13] - Future industry developments are expected to focus on chain operations, involvement of listed companies, and participation of state-owned capital, enhancing trust and operational efficiency [13][14] - The market is anticipated to continue evolving towards a dual-track model of professionalization and market segmentation, with large chains dominating standardized treatments while niche clinics focus on personalized services [14]