研究报告 Research Report 1 Jul 2025 香港医疗 Hong Kong Health Care 2025 年 7 月港股金股：加强创新药产业链的配置 Healthcare Industry Weekly Report (June 23, 2025 - June 27, 2025): Overall stock performance stabilized; Internet healthcare/medical services sector lead this week. (29 Jun 2025) July 2025 Hong Kong Stock Market Top Picks: Strengthen Allocation in the Innovative Industry Chain [Table_yemei1] 观点聚焦 Investment Focus [Table_Info] 股票名称 评级 股票名称 评级 京东健康 Outperform 百奥赛图 Outperform 药明生物 Outperform 方达控股 Outperform 中国生物制药 Outperform ...

Core Viewpoint - The article highlights the innovative drug Koserla, which protects bone marrow stem cells during chemotherapy, and its successful introduction and local production in China through the "Lecang Research and Use + Haikou Production" model [2][4][5]. Group 1: Drug Introduction and Impact - Koserla, a globally pioneering drug, was launched in the U.S. in February 2021 at a price exceeding $1,400 per vial, translating to over 200,000 RMB for a treatment course [4]. - The drug was made available to patients in the Lecang pilot zone shortly after its U.S. launch, with over 30 patients benefiting from it by 2022 when it received conditional approval in China [4][5]. Group 2: Local Production and Cost Reduction - In early 2023, the company submitted a local production application for Koserla, marking the first instance of a domestic company seeking to produce an imported drug in China [5]. - The local production of Koserla has resulted in a significant price reduction, with the domestic price set at 466 RMB per vial, and it has been included in the national medical insurance [5]. Group 3: Industry Response and Future Prospects - The successful implementation of the "Lecang Research and Use + Haikou Production" model has attracted more international innovative drugs to seek domestic market entry and local production [7]. - As of March 2025, 21 drug and medical device products have been approved for domestic use through the Lecang real-world data evaluation, with three products included in the national medical insurance directory [7][8]. Group 4: Supportive Policies and Industry Growth - The article emphasizes the supportive policies in Hainan, such as zero tariffs on raw materials and production equipment, which have fostered the growth of competitive pharmaceutical companies and products [8]. - The new model is seen as a significant boost for the transformation and high-quality development of Hainan's pharmaceutical industry, positioning it as a vital link between China and international innovative drug technologies [8].

证券研究报告|行业定期 生物医药 行业评级 强于大市 （维持评级） 2025年6月8日 白癜风200亿潜在蓝海，关注康哲药业和泰恩康 证券分析师： 陈铁林 执业证书编号：S0210524080007 请务必阅读报告末页的重要声明 华福证券 华福证券 本周专题及创新药投资策略 2 华福证券 华福证券 ◼ 专题：中国白癜风患者超2200万人，创新药潜在市场空间或超200亿，近期或迎来重要催化：康哲芦可替尼NDA获受理上市在即，泰恩康CKBAII 期数据预计Q3披露。中国白癜风患者超2200万人，影响患者的社交和人际关系、健康情况。白癜风现有疗法缺陷多，当前主流白癜风治疗药物包括 钙调神经磷酸酶抑制剂、糖皮质激素等，在疗效、安全性和长期用药依从性方面或多或少存在缺陷，且现有化药均为off-label用药，亟待有对症药 物上市，经过我们测算，中国白癜风创新药潜在市场空间或超200亿元。目前国内白癜风的研发格局良好，赛道拥挤度低。1）康哲药业芦可替尼乳 膏：康哲通过与原研公司Incyte合作取得芦可替尼乳膏在中国及东南亚十一国的独家许可权利，24M9提交NDA获受理，预计25H2上市。海外III期 临床24周主要终点F ...

该负责人表示："相关数据大幅增长，是各部门之间通力合作、不断推动制度集成创新的结果。"据 了解，2021年以来，省药监局、省卫生健康委、海口海关联合发布《支持乐城先行区高质量发展若干措 施》，调整非首次审批模式及内部工作程序，实施二合一融合审批创新，申请环节进一步减少，审批周 期进一步缩短。同时，以医疗机构使用科室为审批单元，实施批量审批，从"一人一品一批"调整为"一 品一院一批"，批准数量大幅增长，实现了从"患者等药械"向"药械等患者"的转变。 此外，乐城先行区医药监管局实施带药带械离院备案措施后，患者用药用械意愿明显增加，医疗机 构积极性明显增强。截至2024年12月，共备案82个特许药械品种带离先行区使用，惠及患者逾1.7万人 次，分别同比增加了9.8%和22%。 强化部门协同，提升审批效率 一季度乐城特许药械使用人次同比增长超四成 海南日报讯(海南日报全媒体记者 陈子仪)连日来，博鳌乐城国际医疗旅游先行区公共保税药仓， 工作人员忙着将芦可替尼、人工耳蜗等进口特许药械产品整理出库，送往园区医疗机构。海南日报全媒 体记者了解到，2025年第一季度，乐城先行区各医疗机构特许药械使用人次达1.6万，同比增长 ...

2021年德镁医药从CMS集团分拆出来，作为独立的业务单元开始运营。 目前，德镁医药主要在中国境内从事皮肤处方药及皮肤学级护肤品业务。而CMS留存集团从事心脑血管、消化、眼科 等领域业务，以及中国境外的皮肤领域业务。 德镁医药采取合作研发与自主研发双管齐下的研发模式，开发皮肤健康领域潜在同类首创(FIC)、同类最佳(BIC)产 品。 截至2025年4月15日，在皮肤处方药领域，德镁医药的主要产品管线包括三款已上市产品、四款处于临床阶段或后期 阶段的候选产品及两款临床前候选产品，覆盖银屑病、白癜风、特应性皮炎(AD)、皮肤挫伤、浅表性静脉炎、静脉曲 张、化脓性汗腺炎(HS)、结节性痒疹(PN)、慢性自发性荨麻疹(CSU)等主要皮肤疾病。 在皮肤学级护肤品领域，公司的代表性产品包括禾零舒缓系列产品与喜辽妥—壬二酸产品系列，该等护肤品主要针对 患有特应性皮炎与寻常痤疮的消费者。 近期，又有医药公司冲击港股上市。 格隆汇获悉，德镁医药有限公司（简称：德镁医药）近期递表港交所，保荐人是华泰国际。 德镁医药于2020年成立，主要营业地点及总部位于海南省海口市，林刚目前是德镁医药的控股股东，同时他也是CMS （康哲药业，8 ...

Group 1 - The core viewpoint of the news is that Kangzheng Pharmaceutical plans to spin off its subsidiary, Demai Pharmaceutical, which focuses on skin health, for independent listing on the Hong Kong Stock Exchange, allowing shareholders to directly hold shares in Demai and benefit from its independent valuation and business growth [1][3] Group 2 - Demai Pharmaceutical operates primarily in the skin health sector in mainland China, with a product portfolio covering major skin diseases such as psoriasis, vitiligo, and atopic dermatitis. The market for skin disease treatment and care in China is projected to reach RMB 169.4 billion by 2030, indicating significant market potential [2] - Demai's product strategy combines prescription drugs and skincare products, creating a comprehensive solution that spans various skin diseases and the entire disease management cycle, positioning the company favorably to seize growth opportunities [2] - The company has a differentiated product mix, a professional marketing team, and extensive academic resources, which may enhance its valuation growth. Demai is expected to lead the industry in prescription drug revenue in 2024, supported by a strong sales network covering over 10,000 hospitals and 100,000 retail pharmacies [2] Group 3 - The spin-off is expected to benefit both shareholders and the company, as it will not involve new share issuance, thus preventing dilution of shareholder equity. This will clarify the business positioning of both Kangzheng and Demai, potentially attracting niche investors and driving value re-evaluation [3] - After the listing, Demai will be able to raise funds directly from the capital market, supporting its business and future expansion. The requirement for regular disclosure of operational and financial status will enhance transparency, allowing investors to make informed decisions [3] - The spin-off is anticipated to create structural benefits for shareholders and open specialized development paths for both companies, serving as a potential benchmark for value re-evaluation in the pharmaceutical industry [3]

Core Viewpoint - 康哲药业 plans to spin off its skin health subsidiary, 德镁医药, and list it on the Hong Kong main board through a distribution of shares to existing shareholders, without diluting their equity [1] Group 1: Company Overview - 德镁医药 focuses on skin health and is responsible for 康哲药业's domestic skin health business, providing comprehensive solutions from prevention to long-term care [1] - The company has incurred losses during the performance record period due to ongoing investments in business development, which aligns with the growth logic of a developing enterprise [1] Group 2: Product Pipeline and Market Position - 德镁医药's product pipeline includes three marketed products, four candidates in clinical or late-stage trials, and two preclinical candidates, covering major skin diseases such as psoriasis, vitiligo, and atopic dermatitis [2] - The company ranks first among Chinese innovative pharmaceutical companies in terms of the number of skin disease indications covered by products in late-stage clinical trials or commercialization [2] - Notable products include the innovative drug, 芦可替尼乳膏, which targets the unapproved treatment area of vitiligo, and the commercialized drug IL-23益路取, which is penetrating the psoriasis market [1][2]

文｜胡香赟 编辑｜海若镜 40多年前，当传奇巨星迈克尔·杰克逊踩着太空步在舞台上"封神"时，其肤色由黑到白的奇异转变，也让彼时尚不为大众熟知的皮肤病——白癜风，成为社 会关注的焦点。 在中国，白癜风患者数量超1000万人。但由于致病机理复杂，市面上能有效治疗白癜风的药物寥寥无几。直到去年9月，一款专门针对该疾病而开发的药 物"芦可替尼乳膏"，正式在国内递交上市申请。 市场仿佛已经提前嗅到了一个百亿市场的爆发。尽管芦可替尼乳膏尚未获批，但其背后的销售"操盘手"康哲药业（00867.HK），已经决定将持有该药物国 内权益的子公司德镁医药拆分，并在香港独立上市。 4月底，德镁医药递交招股书，市场得以窥见其真容：产品管线几乎囊括了康哲药业这家老牌CSO公司决心发力皮肤健康赛道后，从世界各地搜罗到的优质 品种，其中不乏多款已上市的成熟药物。 凭借这些，过去3年间，德镁医药虽还未实现盈利，但每年都有可观的现金流进账。2024年，公司收入突破6亿元。 脱离母公司支持后，背靠有着"刚性治疗需求"的皮肤病市场，德镁医药能否在港股生物科技版块杀出重围？高度依赖引进的策略，又能否为这个想打造皮肤 药帝国的公司，构建起足够高的产品壁 ...

Core Viewpoint - Kangzheng Pharmaceutical is planning to spin off its subsidiary, Demai Pharmaceutical, which focuses on skin health, for independent listing on the Hong Kong Stock Exchange. This move raises questions about whether it is a strategic decision or an attempt to offload a loss-making entity [1][4]. Group 1: Spin-off Details - The spin-off will involve a distribution of 90.8% of Demai's shares to existing shareholders, with no new stock issuance for financing. This allows shareholders to directly hold shares of Demai and benefit from independent valuation premiums [1][2]. - Demai Pharmaceutical has shown revenue growth from 384 million yuan in 2022 to 618 million yuan in 2024, but its losses have also increased from 55.17 million yuan to 106 million yuan during the same period [2][3]. Group 2: Financial Performance - Demai's gross margin for prescription drugs is projected to decline from 76.6% in 2023 to 61.7% in 2024, contributing to an overall gross margin drop from 76.9% to 63.5% [2][3]. - The company's sales expense ratio has risen from 57.7% to 62.9%, with sales expenses reaching 388 million yuan in 2024, nearly matching its gross profit [2][3]. Group 3: Strategic Context - Kangzheng Pharmaceutical is facing significant performance pressure, with a revenue decline of 6.8% to 7.469 billion yuan and a net profit drop of 32.3% to 1.613 billion yuan in 2024. The decline is attributed to the impact of national procurement policies on key products [4][5]. - The spin-off aims to achieve three objectives: shedding the loss-making skin business, allowing Demai to raise capital independently, and enhancing the overall market valuation of the group by focusing on higher-margin areas [4][5]. Group 4: Market Landscape - The skin health market is projected to grow significantly, with an estimated market size of 254.9 billion yuan by 2035 and a compound annual growth rate exceeding 15% [4]. - However, Demai faces intense competition from stronger players in the skin health sector, and its reliance on generic products and high sales expenses raises concerns about sustainability [5].

星标 ★ IPO日报 精彩文章第一时间推送 近日，康哲药业(00867.HK)发布公告，建议将旗下皮肤业务附属公司德镁医药股份分拆并在港交所主板独立上市。 同时，德镁医药有限公司（下称"德镁医药"）向港交所提交了上市申请，独家保荐人为华泰国际。 需要指出的是，康哲药业此次分拆将以实物方式向其股东分派其持有的所有德镁医药股份，而德镁医药以介绍方式在香港主板上市。 制图：佘诗婕 分拆 资料显示，康哲药业是一家开曼群岛注册的有限公司，在2010年9月登陆港交所主板，聚焦于心脑血管、中枢神经、消化及眼科等专科 业务，以及港、澳、台及东南亚市场的皮肤健康业务。创新药方面，公司已累计有5款创新药进入商业化，包括莱芙兰、美泰彤、维福 瑞、益路取和维图可，重磅单品芦可替尼有望2025年内实现销售。 康哲药业目前市值约208亿港元（约合人民币195.31亿元），自从4月22日发布分拆消息后，股价连续上涨三个交易日。 据最新披露，康哲药业2024年实现营业收入74.7亿元，同比下降6.8%；年度溢利16.1亿元，同比下滑32.3%，经调整后净利润为17.1亿 元，同比下降36.7%。 按照全药品销售收入口径来看，2024年，公司 ...