急性缺血性脑卒中的病理过程高度复杂且相互关联，临床亟需多靶点多机制协同干预，以实现对复杂的 缺血级联反应的更有效调控，从而提高治疗效果和患者生活质量。注射用Y-3可解离PSD95-nNOS耦 联，抑制MPO活性，还可增强α2-GABAA受体(一种具有抗抑郁、抗焦虑功能的GABAA受体亚型)活 性，通过这种多靶点高选择性协同机制，有望实现"卒中治疗与卒中后抑郁焦虑预防"同步干预的技术突 破，使注射用Y-3有望成为一种疗效优异，作用更全面的新型脑细胞保护剂。 康哲药业(00867)发布公告，1类新药注射用Y-3(拟定中文通用名：注射用洛贝米柳)(注射用Y-3或"产品") 新药上市许可申请(NDA)已于2025年12月11日获得中国国家药品监督管理局(NMPA)受理。产品为一种 拟用于急性缺血性卒中的脑细胞保护剂。 作为全球首个基于脑卒中病理过程重要靶点PSD95-nNOS和MPO开发的脑细胞保护剂，注射用Y-3作用 于缺血性脑卒中缺血级联反应多个关键病理过程，通过多靶点高选择性协同，更有利于发挥脑细胞保护 作用，产品具有优异的治疗缺血性脑卒中和潜在的预防卒中后抑郁焦虑症状的作用。产品中国III期临床 研究由首都医 ...

智通财经APP讯，康哲药业(00867)发布公告，1类新药注射用Y-3(拟定中文通用名：注射用洛贝米柳)(注 射用Y-3或"产品")新药上市许可申请(NDA)已于2025年12月11日获得中国国家药品监督管理局(NMPA)受 理。产品为一种拟用于急性缺血性卒中的脑细胞保护剂。 根据国家卫健委发布的《脑血管病防治指南(2024年版)》，我国每年新发卒中约394万例，占全球新发 病例三分之一，其中缺血性卒中占比约72%，年新发病例超280万;现患病的卒中患者已超2800万人。 2021年中国死因监测数据显示，卒中死亡占全国总死亡人数的23%。过去三十年，我国卒中相关残疾的 疾病负担持续加重，叠加人口老龄化加快等因素，未来卒中防控压力将进一步增大，给患者家庭和社会 带来巨大挑战。此外，卒中后抑郁和焦虑是卒中常见并发症，发病率分别达到约30%和25%，会影响患 者神经功能恢复，甚至增加死亡风险，严重影响患者预后。注射用Y-3对广大卒中患者长期神经功能改 善和总体预后具有重大潜在价值，市场前景广阔。 于2023年8月24日，本集团通过本公司全资附属公司与一家以临床需求为导向、创新与研发驱动的新药 企业南京宁丹新药技术股 ...

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、 ...

近年来，以光子嫩肤、水光针、肉毒素除皱等为代表的"轻医美"项目正快速渗透现代生活，消费者甚至 只需用午休间隙，就能接受一次项目治疗，之后迅速回归日常工作和社交。 作为医疗美容领域的重要分支，"轻医美"概念在国内已有十年的发展历程。艾媒网发布的报告曾指出， 轻医美是介于手术整形和生活美容间的医美项目，其概念最早兴起于海外，2015年开始逐渐在中国普 及。 在艾尔建美学行业峰会暨乔雅登十周年盛典（下称"峰会"）举办期间，多名医美业内人士在接受时代财 经采访时指出，十年的时间，中国轻医美市场发生了深刻的变化。产品从"一支玻尿酸打全脸"的单一粗 放变得丰富多元，价格从模糊日益走向透明。此外，随着消费观念转变和认知升级，用户画像及其需求 也在迭代。 艾媒咨询发布的《2024年中国生活美容及轻医美市场研究报告》显示，2017年至2023年，中国轻医美市 场用户规模不断增长，2023年用户规模达2354万，预计到2025年将达到3105万人。另据《2025中国医美 行业研究报告》指出，2021-2025年，中国医美市场规模从2274亿元跃升至3640亿元，轻医美占比增至 53.3%。 行业的繁荣也伴随着剧烈的洗牌和分化，单 ...

股价：13.28 港元 主要数据 | 行业 | 医药 | | --- | --- | | 公司网址 | www.cms.net.cn | | 大股东/持股 | Treasure Sea Limited | | 实际控制人 | 林刚 | | 总股本(百万股) | 2439.53 | | 流通 B/H 股(百万股) | 2439.53 | | 总市值（亿港元） | 324 | 行情走势图 业绩重回上升轨道，潜力大单品迎来收获期 推荐（首次） 医药 2025 年 12 月 4 日 康哲药业(0867.HK) 证券分析师 | 叶寅 | 投资咨询资格编号 | | --- | --- | | | S1060514100001 | | | BOT335 | | | YEYIN757@pingan.com.cn | | 韩盟盟 | 投资咨询资格编号 | | | S1060519060002 | | | hanmengmeng005@pingan.com.cn | | 张梦鸽 | 投资咨询资格编号 | | | S1060525070003 | | | ZHANGMENGGE752@pingan.com.cn | 平安观点： | ...

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]

Core Viewpoint - In 2024, Kangzhe Pharmaceutical's core cardiovascular business faced revenue and profit declines due to unsuccessful bidding in centralized procurement, prompting its subsidiary Dermavon to apply for an IPO on the Hong Kong Stock Exchange despite ongoing losses in its skin care segment [3][4]. Group 1: Company Overview - Dermavon, established in 2020 and spun off from Kangzhe in 2021, focuses on skin prescription drugs and skin care products, holding three marketed drugs and a developing skin care brand [4][6]. - Kangzhe Pharmaceutical's revenue in 2024 was 7.469 billion yuan, a decrease of 6.8% year-on-year, with net profit dropping by 32.3% to 1.613 billion yuan [4]. Group 2: Financial Performance - Dermavon reported revenue growth from 384 million yuan in 2022 to 618 million yuan in 2024, but net losses increased from 55.17 million yuan to 106 million yuan during the same period [8][9]. - Sales expenses for Dermavon rose from 246 million yuan in 2022 to 388 million yuan in 2024, consistently accounting for around 60% of revenue [9][10]. Group 3: Market Position and Challenges - Dermavon's core product, Yilvqu (for psoriasis), lacks price competitiveness compared to established competitors, which impacts market penetration and necessitates high marketing expenditures [11][12]. - The skin care segment, particularly the He Ling series targeting sensitive skin, faces intense competition from established brands like Winona, which reported revenue of 4.91 billion yuan in 2024, significantly overshadowing Dermavon's performance [13][14]. Group 4: Future Outlook and Strategic Goals - Dermavon aims for a compound annual growth rate of over 50% over the next five years, targeting sales exceeding 10 billion yuan by 2029, although achieving this goal poses significant challenges given the current market dynamics [14][18]. - The company's reliance on Kangzhe for resources and sales channels raises concerns about its independence and long-term viability, as it struggles to establish a self-sustaining business model [16][17].

Group 1 - The core viewpoint of the news highlights the strong performance of the Hong Kong Stock Connect Innovative Drug ETF, which has gained 1.2% with a trading volume of 351 million yuan and a total fund size of 2.079 billion yuan as of November 10 [1] - Key performing stocks within the ETF include InnoCare Pharma-B, Bionet, and Ascletis Pharma, with respective gains of 5.4%, 4.43%, and 4.37% [1] - Conversely, stocks such as Kangzhe Pharmaceutical, MIRXES-B, and Innovent Biologics showed weaker performance, with declines of 1.28%, 0.94%, and 0.65% respectively [1] Group 2 - The innovative drug sector is identified as the largest investment opportunity in the pharmaceutical sector for 2025, with a focus on dual/multi-target drugs, chronic disease medications addressing unmet clinical needs, and ADCs [2] - There is a noted improvement in domestic and international innovative drug financing data, with an upward trend in CXO industry orders, indicating a potential recovery in valuations and performance [2] - The medical device sector is experiencing accelerated approvals for innovative products, such as the approval of the chest and abdominal aortic stent system by Xianjian Technology, which is expected to enhance long-term profit margins [2] Group 3 - The Hong Kong Stock Connect Innovative Drug ETF and its linked funds passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, with the top ten weighted stocks including BeiGene, China Biologic Products, and Innovent Biologics [3]