德镁医药收入快速增长，分拆上市有助于价值重估。分产品来看，皮肤健康线（德镁医药）表现突出， 2025 年上半年实现收入4.98 亿元（+104.3%）。德镁医药深度布局不同作用机理及治疗方式的皮肤疾病 处方药，目前已有3 款已上市产品（益路取、喜辽妥、安束喜），4 款处于临床阶段的管线产品（芦可 替尼乳膏、MG-K10、povorcitinib、CMSD001），其中芦可替尼乳膏白癜风适应症的NDA 处于审评阶 段。德镁医药拥有完善的皮肤专科销售及学术推广团队，覆盖主流院内、院外渠道，我们认为随着芦可 替尼乳膏等重磅品种陆续获批，德镁医药的业绩有望持续保持高速增长。公司拟通过介绍上市及实物分 派的方式分拆德镁医药于联交所主板独立上市，有助于其皮肤科产品/管线价值重估。 盈利预测和估值。我们预计2025 年至2027 年公司营业收入分别为80.53亿元、94.39 亿元和116.51 亿 元，同比增速分别为7.8%、17.2%和23.4%；归属于上市公司股东的净利润分别为16.85 亿元、19.56 亿 元和24.65 亿元，同比增速分别为4.0%、16.1%和26.1%，以8 月22 日收盘价计算，对应PE ...

[Table_Rank] 评级： 增持 王斌 首席分析师 SAC 执证编号：S0110522030002 wangbin3@sczq.com.cn 电话：010-81152644 [市场指数走势（最近 Table_Chart] 1 年） 资料来源： wind -0.2 0.0 0.2 0.4 0.6 0.8 1.0 1.2 24-08 24-09 24-10 24-11 24-12 25-01 25-02 25-03 25-04 25-05 25-06 25-07 25-08 康哲药业 恒生指数 [Table_BaseData] 公司基本数据 [Table_Title] 创新产品持续增长，皮肤健康线表现突出 [Table_ReportDate] 康哲药业(0876.HK)公司简评报告 | 2025.08.25 核心观点 请务必仔细阅读本报告最后部分的重要法律声明 [Table_Authors] [Table_OtherReport] [Table_Summary] 最新收盘价（港元） 13.44 一年内最高/最低价（港元） 14.16/6.71 市盈率（当前） 18.12 市净率（当前） 1.76 总股本（亿 ...

Core Viewpoint - Vitiligo is a complex autoimmune disease with no clear treatment options, affecting approximately 30 million people in China, with a significant portion of patients experiencing anxiety and depression due to the condition [3][4]. Treatment Landscape - Current treatment methods for vitiligo in China are limited, primarily involving topical corticosteroids and calcineurin inhibitors, which only suppress immune responses and do not promote repigmentation or prevent relapse [4]. - The FDA has approved the JAK inhibitor ruxolitinib cream for the treatment of non-segmental vitiligo in patients aged 12 and older, but it is not yet available in China and cannot be used for children under 12 [5]. Market Potential - The market for innovative vitiligo treatments in China is projected to reach 120 billion to 259 billion yuan under conservative to optimistic scenarios, indicating a significant opportunity for new products [6]. - The current pipeline for vitiligo treatments is not overly crowded, suggesting that successful new therapies that balance safety and efficacy could quickly gain market share due to unmet clinical needs [6]. Research and Development - Several domestic pharmaceutical companies are actively developing new treatments for vitiligo, including new JAK inhibitors and innovative approaches like the CKBA ointment being developed by TianKang, which targets T-cell fatty acid metabolism [5][6]. - TianKang has reported promising results from the Phase II clinical trials of CKBA ointment and is advancing to Phase III trials while seeking breakthrough therapy designation from the National Medical Products Administration [5].

Core Viewpoint - The treatment of vitiligo in China is currently limited and lacks effective drugs, with a significant patient population facing challenges in management and treatment options [1][3]. Group 1: Disease Overview - Vitiligo is an autoimmune disease characterized by the destruction of melanocytes, leading to skin depigmentation, and affects 1% to 3% of the global population, with approximately 30 million patients in China [1][3]. - A significant portion of patients (63.4%) experience onset before the age of 20, and 75% of patients suffer from anxiety and depression due to the condition [1][3]. Group 2: Current Treatment Landscape - Current treatment methods in China primarily involve topical corticosteroids and calcineurin inhibitors, which only suppress immune responses and do not promote repigmentation or prevent relapse [3]. - The FDA approved the JAK inhibitor ruxolitinib cream for the treatment of non-segmental vitiligo in patients aged 12 and older, but it is not yet available in China and cannot be used for children under 12 [3][4]. Group 3: Market Potential and Drug Development - There is a high demand for treatment among the 12 million patients aged 2 to 12 in China, representing 40% of the patient population [3]. - Several pharmaceutical companies are developing new drugs for vitiligo, including new JAK inhibitors and innovative treatments like CKBA ointment by TianKang, which targets T-cell fatty acid metabolism [3][4]. - According to Huafu Securities, the long-term market potential for innovative vitiligo drugs in China is estimated to reach 120 billion to 259 billion yuan under different scenarios, indicating a significant market opportunity [5].

Core Insights - Chinese pharmaceutical companies are transitioning from "followers" to "leaders" in the global market, particularly focusing on Southeast Asia as a new growth area [1][3] - The recent secondary listing of Kangzhe Pharmaceutical on the Singapore Exchange marks a significant step in its internationalization strategy, aiming to leverage Southeast Asia's vast market potential [1][3][10] Market Expansion Strategies - Kangzhe Pharmaceutical is utilizing Singapore as a strategic hub to access the Southeast Asian pharmaceutical market, which has over 600 million people [3][10] - The company has established a comprehensive business ecosystem in Singapore, covering research, production, and sales, to enhance operational efficiency and market responsiveness [8][10][12] Challenges and Solutions - The company faces challenges such as fragmented regulations in emerging markets, varying payment capabilities, and differing healthcare needs across countries [5][6] - To address these challenges, Kangzhe Pharmaceutical has implemented localized registration strategies and established dedicated teams with extensive local experience [5][8] Product Focus and Innovation - Kangzhe Pharmaceutical is concentrating on specialized fields such as dermatology and ophthalmology, aiming to become a leader in niche markets rather than competing in saturated areas like oncology [13][14] - The company has a robust pipeline of approximately 40 innovative products, with a focus on high-quality, cost-effective solutions tailored to local market needs [14][17] Future Outlook - The company has invested over $100 million in the Southeast Asian and Middle Eastern markets over the past three years, indicating a strong commitment to expanding its footprint in these regions [10] - Kangzhe Pharmaceutical aims to leverage its established R&D capabilities and cost advantages from the Chinese market to enhance its product offerings in Southeast Asia [16][17]

Investment Rating - The industry investment rating is "Outperform the Market" [1][47]. Core Insights - The white spot market for vitiligo treatment is vast, with a potential market size expected to reach 21.7 billion yuan by 2030, driven by an increasing number of patients and the need for effective treatments [3][15][39]. - Current treatment options are inadequate, with no approved products specifically for vitiligo in China, highlighting a significant gap in the market that innovative drugs could fill [3][26]. - The competitive landscape is favorable, with several small pharmaceutical companies and leading firms vying for market share, and key products expected to receive approval soon [3][39]. Summary by Sections Part 1: Patient Demographics and Health Risks - The prevalence of vitiligo is significant, with approximately 22.83 million patients in China, of which 54.01% are receiving treatment [3][15]. - The condition is associated with severe psychological impacts, including a higher incidence of depression among patients [3][10]. Part 2: Current Treatment Limitations - Existing treatments, primarily involving drug therapy and phototherapy, have shown limited effectiveness, necessitating the introduction of new drugs with higher repigmentation rates [3][24]. - The current market lacks approved medications specifically for vitiligo, with existing drugs primarily approved for other conditions [3][26]. Part 3: Competitive Landscape and Drug Development - The vitiligo treatment sector is characterized by a lack of approved products, with several drugs in various stages of clinical trials, including one in Phase III and six in Phase II [3][39]. - JAK inhibitors are identified as key targets in drug development, with the first approved topical JAK1/JAK2 inhibitor, Ruxolitinib cream, showing promising sales growth [3][32][39]. - The innovative drug market for vitiligo is projected to reach 10 billion yuan, with significant interest in companies like Kangzheng Pharmaceutical and TianKang [3][39]. Part 4: Investment Recommendations - The report suggests focusing on the progress of drug development in the vitiligo sector and monitoring companies involved, including Kangzheng Pharmaceutical, TianKang, Huadong Medicine, and others [3][39].

Core Viewpoint - Kangzhe Pharmaceutical has successfully completed a secondary listing on the Singapore Exchange, marking its expansion into international capital markets after its initial public offering on the Hong Kong Stock Exchange in September 2010 [1] Group 1: Company Background - Kangzhe Pharmaceutical was established in 1995, initially focusing on contract sales organization (CSO) and marketing foreign and domestic pharmaceuticals [3] - The company transitioned from pure agency operations to self-operated products after acquiring full control of Ganfu Le in 2013 [3] - Kangzhe's business currently spans four major areas: cardiovascular, digestive, dermatology/aesthetic medicine, and ophthalmology [3] Group 2: Recent Developments - In April 2024, Kangzhe Pharmaceutical spun off its dermatology business, Demai Pharmaceutical, for independent listing [1][4] - The decision to list in Singapore is part of the company's strategy to enhance its presence in Southeast Asia and create more opportunities for international business development and potential financing needs [4] Group 3: Financial Performance - Kangzhe Pharmaceutical has experienced a decline in revenue for two consecutive years, with revenues of 6.8 billion, 8.5 billion, 9.24 billion, 7.76 billion, and 7.4 billion from 2020 to 2024 [6] - Net profits during the same period were 2.5 billion, 3 billion, 3.2 billion, 2.4 billion, and 1.6 billion, with a significant 32% year-on-year decline in 2024 [6] - The company's cash flow from operations dropped nearly 50% to 1.269 billion in 2024, indicating deteriorating operational quality [7] Group 4: Market Challenges - The decline in performance is attributed to the impact of centralized procurement, with major products like Dailixin, Yousif, and Bo Yiding losing market share, resulting in a nearly 30% revenue drop to 2.691 billion [7] - The company is facing increased competition in the dermatology sector, and Demai Pharmaceutical has reported cumulative losses of 165 million from 2022 to 2024 [8] - Despite the challenges, Kangzhe is accelerating the commercialization of its innovative drug, Lurcobatin Cream, expected to launch in the second half of 2025, targeting a market with over 22 million patients in China [8]

Core Insights - 康哲药业 successfully held a forum and appreciation dinner in Singapore to celebrate its secondary listing on the Singapore Exchange, gathering nearly 150 industry leaders and stakeholders [1][3] - The forum focused on the development of the pharmaceutical industry in Singapore and emerging markets, discussing strategies for internationalization and commercialization of innovative drugs [3][5] Industry Overview - Emerging markets, including Asia-Pacific, India, Africa & Middle East, and Latin America, are projected to reach a pharmaceutical market size of $336 to $384 billion by 2028, nearing the $410 billion expected for Western Europe [5] - Singapore is positioned as a hub for capital and innovation, with a shift from traditional third-party logistics to more integrated commercial strategies being essential for sustainable success in Southeast Asia [5] Company Strategy - 康哲药业 aims to expand its strategic vision across the Asia-Pacific market, leveraging its established resources in China and using Singapore as a regional hub to drive innovation through a comprehensive "research-production-sales-investment" model [6][8] - The company has introduced its international business cluster, highlighting its PharmaGend factory, which aims to become the largest and most trusted CMO/CDMO in Southeast Asia, with a production area of approximately 30,000 square meters and dual certifications from the FDA and HSA [8] Innovation and Development - 康哲药业 is establishing a global incubation platform for early-stage biopharmaceutical innovations through its HiGend initiative, enhancing the efficiency of global drug development [9] - The company is also setting up the CMS R&D Institute in 2024, focusing on early-stage innovative drugs, aiming to synchronize "China speed" with global standards [8][9] Market Exploration - Chinese pharmaceutical companies are increasingly exploring emerging markets, with over $10 billion in upfront payments from licensing deals in the past three years, primarily focused on mature markets [11] - The need for a comprehensive internationalization strategy that integrates research, production, and sales is emphasized for sustainable growth in new markets [12]

Company Overview - 德镁医药 is an innovative pharmaceutical company focused on skin health, operating under 康哲药业. It specializes in prescription drugs and dermatological skincare products, with three products already on the market and several candidates in various clinical stages [1] Financial Performance - Revenue for 2023 reached RMB 472.56 million, a year-on-year increase of 23.2%, driven by a robust growth in prescription drugs and a significant surge in skincare products [2][3] - Prescription drug revenue was RMB 424.82 million in 2023, up 13.6% from RMB 374.04 million in 2022, accounting for 89.9% of total revenue [2] - Skincare product revenue skyrocketed by 404.4% to RMB 47.74 million in 2023, primarily due to successful e-commerce promotions [3] Profitability and Margins - The overall gross margin improved to 76.9% in 2023, up 6.8 percentage points from the previous year, with a significant reduction in net loss to RMB 5 million [5] - The gross margin for prescription drugs was 76.6%, while skincare products achieved a gross margin of 79.0% [5] - However, the gross margin is expected to decline to 63.5% in 2024 due to increased costs and pricing pressures from insurance adjustments [7][8] Debt Structure and Cash Levels - A debt-to-equity conversion in 2024 significantly improved the company's balance sheet, reducing liabilities from RMB 15.75 billion to RMB 1.54 billion [10] - Despite the reduction in debt, cash reserves remain tight, with only RMB 2.82 billion available at the end of 2024 [10] Competitive Advantages - 德镁医药 has the broadest coverage of skin disease indications in China, with nine conditions addressed, surpassing competitors [11] - Key products like 益路取 for psoriasis and 喜辽妥 for scar treatment have unique advantages, including insurance coverage and lack of direct competition [12][14] - The company benefits from a strong distribution network, leveraging 康哲药业's existing relationships with over 10,000 hospitals and 100,000 pharmacies [13] Industry Context - The Chinese skin treatment and care market was valued at RMB 76.4 billion in 2023, with a projected CAGR of 10.6% through 2035, driven by the high prevalence of chronic skin diseases [20] - The demand for dermatological skincare products is also increasing, with significant growth in e-commerce channels [20]

Core Insights - The report emphasizes the flourishing approval of new drugs and highlights the importance of focusing on technological tracks and opportunities within the industry chain [1][5] - It suggests a dual growth strategy combining internal and external growth, particularly in the context of the imminent patent cliff for IO1.0 and the increasing recognition of Chinese innovative pharmaceutical companies globally [5] Industry Overview - The report notes a significant recovery in domestic healthcare policies, including the integration of commercial insurance into the medical insurance system and the inclusion of high-priced innovative drugs in the Class B medical insurance catalog [5] - The overall revenue growth rate for chemical pharmaceutical companies in 2024 is projected at 4.10%, a substantial increase from 0.24% in 2023, while the net profit growth rate is expected to be 51.66% [12][15] Investment Opportunities - Short-term focus is recommended on certain tracks with high certainty, such as IO+ADC, while long-term investments should target new technologies with significant potential, including small nucleic acids and CAR-T [5] - The report categorizes various technological tracks for investment, including combinations of PD-1 with other mechanisms and innovative solutions for unmet clinical needs [5] Company Valuations - The report provides a comparative valuation of unprofitable innovative pharmaceutical companies, highlighting their market capitalizations and projected revenues for 2024 to 2027 [6] - It also presents a comparative valuation of profitable innovative pharmaceutical companies, detailing their market capitalizations and projected net profits for the same period [8] Performance Review - The report reviews the performance of pharmaceutical companies in 2024 and Q1 2025, noting that while the overall industry faced temporary pressure, gross profit margins have steadily improved [12][15] - It highlights that many small and mid-cap innovative pharmaceutical companies have turned profitable in Q1 2025, indicating a positive trend in the sector [18]