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]

Investment Rating - The report gives a "Buy" rating for the company, 康哲药业 (0867.HK), for the first time [7]. Core Views - The company has successfully transitioned into a new product era, with its innovative transformation showing significant results. The impact of national procurement on its products has reached a turning point, and the sales of exclusive/brand and innovative products continue to grow, indicating a recovery in performance [7]. - The company is focusing on dual engines of "cooperative research and independent research" to drive innovation, with a rich product pipeline covering multiple therapeutic areas. The company aims to enhance its market position through strategic international expansion and innovative product launches [6][10]. Summary by Sections 1. Successful Innovation Transformation - The company has adopted a dual approach of "cooperative research + independent research" to efficiently promote clinical development and commercialization. It has transitioned from a single drug agency model to an innovation-driven pharmaceutical enterprise since 2018 [10]. - As of the first half of 2025, the company has a pipeline of 40 products, with five innovative products approved for sale in China [10]. 2. Impact of National Procurement - The company faced a decline in revenue and net profit in 2023 due to three products being included in national procurement, leading to a significant drop in sales and market share [12]. - In 2025, the company’s performance rebounded, achieving revenue of 40.02 billion yuan (up 10.8% year-on-year) and a net profit of 9.41 billion yuan (up 3.3% year-on-year) [12]. 3. Innovative Drug Strategy - The company has successfully launched four innovative drugs, with a focus on chronic kidney disease, psoriasis, and epilepsy. Two additional products are pending approval, and three are in clinical phase III trials [34][36]. - The company’s innovative pipeline includes products targeting skin health, with plans for a spin-off of 德镁医药 to unlock its value in the skin health sector [21][34]. 4. Financial Forecast and Valuation - The company is expected to achieve net profits of 16.70 billion yuan, 20.05 billion yuan, and 23.72 billion yuan for the years 2025, 2026, and 2027, respectively, with corresponding P/E ratios of 18, 15, and 12 times [7]. - The company’s P/E valuation for 2025 is estimated at 18 times, which is lower than the average P/E of comparable companies at 28 times [7].

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: China Medical System Holdings Limited 康哲藥業控股有限公司*（*僅供識別） 呈交日期: 2025年12月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00867 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 20,000,000,000 | USD | USD | 0.005 | | | 100,000,000 | | 增加 / 減少 (-) | | | | | | USD | | | | | 本月底結存 | | | 20,00 ...

Core Viewpoint - 康哲药业's subsidiary, 德镁医药, has submitted a listing application to the Hong Kong Stock Exchange, aiming for a spin-off listing without financing, reflecting a trend of pharmaceutical companies pursuing independent growth [1][6] Company Overview - 德镁医药, established in 2020, has been operating as an independent unit since 2021, focusing on skin health and ranking first among Chinese innovative pharmaceutical companies in skin prescription drug revenue in 2024 [2] - The skin disease treatment and care market in China is projected to reach a scale of 899 billion yuan in 2024, with a compound annual growth rate of 10.4% from 2024 to 2035 [2] Financial Performance - 德镁医药's revenue from 2022 to the first half of 2025 is reported as follows: 384 million yuan, 473 million yuan, 618 million yuan, and 498 million yuan, respectively, while the company has not yet achieved profitability, with net losses of 55.17 million yuan, 4.70 million yuan, 106 million yuan, and 31.08 million yuan during the same period [2][5] - The revenue structure is primarily composed of skin prescription drugs and dermatological skincare products, with prescription drugs accounting for nearly 90% of total revenue [2] Product Portfolio - The main products include益路取 (替瑞奇珠单抗注射液), 喜辽妥 (多磺酸粘多糖乳膏), and 安束喜 (聚多卡醇注射液), along with four candidates in clinical stages, targeting diseases like psoriasis and vitiligo [3] - The candidate product, 芦可替尼乳膏, is expected to be a new growth point, with its new drug application accepted by the National Medical Products Administration in September 2024 [3] Challenges Ahead - 德镁医药 faces challenges in original research capabilities, as its main products are primarily licensed or acquired, necessitating upfront licensing fees [4] - The company has incurred high sales and marketing expenses, attributing its losses to costs associated with promoting newly acquired or launched products [4][5] - The transition to an independent entity requires enhancing operational capabilities, as evidenced by the significant reduction in procurement from 康哲药业 over the years [5] Industry Context - The trend of pharmaceutical companies pursuing spin-off listings is gaining momentum, with several companies, including 三生制药 and 复星医药, also planning similar moves [6] - The rationale for these spin-offs includes expanding financing channels, accelerating internationalization, and enabling strategic transformation [6]

Core Insights - The pharmaceutical industry is witnessing significant strategic collaborations, with companies like Kangzheng Pharmaceutical partnering with global giants like Novartis to enhance their market presence in specialized fields such as ophthalmology and dermatology [1] Group 1: Kangzheng Pharmaceutical's Strategic Moves - Kangzheng Pharmaceutical has signed a distribution agreement with Novartis, gaining exclusive rights for two ophthalmic drugs in mainland China, indicating a strong commitment to the ophthalmology sector [1] - The company is also focusing on its dermatology segment through the spin-off of its skin health business, Dermy Pharmaceuticals, which has submitted a listing application to the Hong Kong Stock Exchange [1] Group 2: Market Potential in Dermatology - The white spot disease (vitiligo) market is highlighted as a significant opportunity, with the treatment market projected to grow from 2.8 billion RMB in 2024 to approximately 21.9 billion RMB by 2035, reflecting a compound annual growth rate (CAGR) of 20.7% [2] - Dermy Pharmaceuticals is advancing its lead product, Ruxolitinib cream, which is the first and only FDA and EMA-approved topical JAK inhibitor for vitiligo, currently in the new drug application approval stage in China [3] Group 3: Other Dermatological Conditions - Psoriasis, affecting around 7.2 million patients in China, is seeing a shift towards biologics and small molecule drugs as preferred treatment options, with Dermy Pharmaceuticals' Tildrakizumab injection positioned as a second approved IL-23 monoclonal antibody in the market [4] - Atopic dermatitis, impacting over 54 million people in China, is expected to see its treatment market grow from 12.1 billion RMB in 2024 to 39.4 billion RMB by 2035, with Dermy Pharmaceuticals pursuing multiple pipeline strategies to address this demand [6][7] Group 4: Acne Treatment Innovations - Acne is a prevalent skin issue, with a reported prevalence of 8.1% in the Chinese population, leading to a growing market for effective skincare solutions [8] - Dermy Pharmaceuticals is leveraging its brand advantage with the launch of the Xiliao Duo series, targeting acne treatment and prevention, while also offering soothing products for atopic dermatitis and sensitive skin [8]