12月18日上午，一辆满载进口药械的运输车缓缓驶入博鳌乐城国际医疗旅游先行区(以下简称博鳌 乐城)保税药仓。等候在此的保税药仓业务负责人彭思楠看了一眼手表，迅速指挥团队投入作业。 15分钟，这是进入博鳌乐城的特许药械从保税仓直达病房所创造的时间，这样的"乐城速度"让医生 放心开方，特许药械"随取随用"。 海南日报全媒体记者 王子豪 "动作快些，这是封关运作后入仓的第一批药械，两家医院都等着呢!" 而过去，一款进口药械产品从海外抵达海南患者手中大概需要一到两周，"人等药"让患者"望眼欲 穿"。 作为海南自贸港重点园区之一，博鳌乐城以自贸港核心政策为基石、制度集成创新为动力，依托博 鳌医药公用型保税仓库(以下简称保税仓)构建起更为高效便捷的特许药械引进使用"高速路"。 依托博鳌医药公用型保税仓库，患者最快15分钟就能用上药械 博鳌乐城：特许药械等患者正成为常态 制度之变： 从"一品难求"到"全球储备" 走进保税仓内部，2000平方米的仓储空间内别有洞天。 连日来，海南日报全媒体记者深入乐城这座连接国际先进药械与国内患者需求的"桥头堡"，看乐城 如何在全岛封关运作的新起点上，借力政策东风，让全球好药跑出惠民"加速度 ...

Core Viewpoint - The report from Guoyuan International highlights that Kangzhe Pharmaceutical (00867) has established a global pipeline of 40 innovative drugs primarily focused on FIC and BIC, with 5 approved innovative drugs accelerating commercial value release, 7 NDA reviews ongoing, and over 10 clinical trials in progress. The oral JAK1 inhibitor Povorcitinib has received breakthrough therapy designation, and a "Buy" rating is given with a target price of HKD 17.68 per share [1]. Group 1: Innovative Drug Pipeline - The company has a rich pipeline of innovative drugs, with 40 global projects focused on FIC and BIC, and 5 approved innovative drugs accelerating commercial value [2]. - The NDA application for the first-class injectable drug Y-3 has been accepted, which is the world's first brain cell protector developed based on PSD95-nNOS and MPO targets, expected to address both stroke treatment and post-stroke depression and anxiety [2]. - The market potential for injectable Y-3 is estimated at RMB 3 billion [2]. Group 2: Clinical Trials and Market Demand - The oral JAK1 inhibitor Povorcitinib has received breakthrough therapy designation from China's NMPA, targeting adult non-segmental vitiligo, with a large unmet treatment demand in China, where there are approximately 10.3 million vitiligo patients, including 8.2 million with non-segmental vitiligo [2]. - Multiple clinical trials for Povorcitinib are ongoing in various countries, including Phase III trials for non-segmental vitiligo and moderate to severe hidradenitis suppurativa, as well as a Phase II asthma trial [2]. Group 3: Financial Performance - In the first half of 2025, the company achieved revenue of RMB 4.67 billion, a year-on-year increase of 8.9%, and a net profit of RMB 930 million, up 3.1% year-on-year [3]. - The skin health line generated revenue of RMB 498 million, a significant increase of 104.3%, accounting for 10.7% of the group's drug sales [3]. - The company's brand and innovative products generated a total revenue of RMB 2.9 billion, a year-on-year growth of 20.6%, representing 62.1% of total revenue [3]. Group 4: Investment Recommendations - The company's performance is expected to recover, with a significant optimization of its product structure focusing on innovative drugs. Revenue projections for 2025-2027 are RMB 7.86 billion, RMB 8.95 billion, and RMB 10.02 billion, with net profits of RMB 1.667 billion, RMB 1.941 billion, and RMB 2.308 billion respectively [4]. - The target price of HKD 17.68 corresponds to a PE ratio of 16.9 times for 2027, indicating a potential upside of 32% from the current price [4].

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： | ...

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 - The company plans to spin off Dermagene Pharmaceuticals, which will enhance its focus on the skin health sector and unlock significant value from its innovative pipeline [1] Group 1: Business Strategy - The spin-off of Dermagene Pharmaceuticals signifies a systematic layout in the skin health field, with its innovative pipeline covering all indications in skin health, potentially leading to high growth and independent value [1] - The company has five innovative drugs commercialized in China, with three more in the NDA stage, driving growth through a dual strategy of collaboration and self-research [1][2] Group 2: Financial Performance - The company reported a revenue of 4.002 billion yuan in the first half of 2025, a year-on-year increase of 10.83%, and a net profit of 941 million yuan, up 3.38% year-on-year, indicating a potential turning point in performance [1] - The impact of centralized procurement on the company's main products is expected to be fully absorbed by 2024, leading to a stabilization in revenue and a potential performance turnaround [2] Group 3: Future Projections - Revenue projections for the company from 2025 to 2027 are estimated at 8.166 billion yuan, 9.628 billion yuan, and 12.069 billion yuan, with growth rates of 9.3%, 17.9%, and 25.4% respectively [3] - The estimated market value for the company in 2026 is projected to be 67.7 billion HKD, based on a combination of existing and incremental values from both the company and Dermagene Pharmaceuticals [3]

Investment Rating - The report gives an initial investment rating of "Buy" for the company 康哲药业 (00867.HK) [4][8]. Core Views - The company is positioned as a leading innovative platform in the pharmaceutical industry, with a focus on commercializing its innovative pipeline and expanding its market presence [4][7]. - The planned spin-off of 德镁医药 is expected to unlock additional value in the skin health segment, which has a comprehensive pipeline covering all indications in this area [7][8]. - The company has shown signs of a performance turnaround, with a 10.83% year-on-year increase in revenue for the first half of 2025, indicating a potential inflection point in its financial performance [7][17]. Summary by Sections Financial Performance - The company reported a total revenue of 8,013 million RMB in 2023, with a projected revenue of 8,166 million RMB in 2025, reflecting a growth rate of 9.3% [6][8]. - The net profit attributable to shareholders is expected to increase from 1,620 million RMB in 2024 to 1,681 million RMB in 2025, with a growth rate of 3.8% [6][8]. - The company’s earnings per share (EPS) is projected to be 0.69 RMB in 2025, with a return on equity (ROE) of 9.3% [6][8]. Business Strategy - 康哲药业 has undergone multiple transformations over its 30-year history, evolving from a sales agent to a company that controls product rights and now focuses on innovative product development [13][14]. - The company has diversified its business into three main segments: cardiovascular/digestive, skin health, and ophthalmology, aiming to create specialized teams for each area [21][24]. - The internationalization strategy has been accelerated with the recent listing on the Singapore Exchange, marking a significant milestone in its global expansion efforts [24][25]. Innovation and Pipeline - The company has five innovative drugs that have been commercialized in China, with several others in the NDA stage, indicating a robust pipeline for future growth [7][8]. - Key innovative products include 德昔度司他片 for chronic kidney disease anemia and ABP-671 for gout, both of which are expected to contribute significantly to future revenues [43][45]. - The company is leveraging a dual approach of collaboration and self-research to drive innovation, aiming to meet unmet clinical needs and enhance its product offerings [40][41].

Core Viewpoint - Haitong International slightly adjusted the revenue forecast for Kangzheng Pharmaceutical (00867) for 2025-26E to 8.33/9.30 billion HKD, representing a year-on-year increase of +11.5%/+11.6% [1] - The net profit forecast for the same period was also adjusted to 1.67/1.88 billion HKD, with year-on-year growth of +3.4%/+12.9% [1] - The valuation model was changed to a discounted cash flow (DCF) model to better reflect the long-term value of the pipeline cash flow from Demy Pharmaceutical, with a target price of 18.38 HKD (+85%) [1] Financial Performance - Kangzheng Pharmaceutical achieved a revenue of 4 billion HKD in the first half of the year, a year-on-year increase of +11% [2] - Revenue from exclusive/brand products and innovative products reached 2.9 billion HKD, up +21% year-on-year, which is the core driver of the company's performance recovery [2] - The gross profit margin was 72%, with R&D expenses of 570 million HKD (down -8% year-on-year) and a net profit of 940 million HKD (up +3% year-on-year) [2] Business Growth - The recovery in revenue is attributed to the clearance of the impact from existing centralized procurement products and the steady growth of core products such as Weifurui and Meitai Tong [3] - Exclusive/brand and innovative product sales accounted for 62.1% of total revenue, up from 56.1% in the same period last year [3] - Revenue by segment includes: cardiovascular segment 2.2 billion HKD (+0.6% YoY), digestive/immunity segment 1.4 billion HKD (+4.9% YoY), skin health segment 500 million HKD (+104% YoY), and ophthalmology segment 360 million HKD (+18% YoY) [3] Innovation and Pipeline - The company has three New Drug Applications (NDA) under review, including Dexamethasone and Luracitinib [4] - Approximately ten clinical trials are progressing in China, including treatments for ischemic stroke and specific dermatitis [4] - Other potential products include Povorcitinib and CMS-D001, which are in various stages of clinical trials [4] Spin-off Plans - Kangzheng Pharmaceutical plans to spin off Demy Pharmaceutical for independent listing on the Hong Kong Stock Exchange by April 2025 [5] - The spin-off will be executed through a distribution method, allowing shareholders to directly hold shares in Demy Pharmaceutical [5] - Demy Pharmaceutical's pipeline addresses significant unmet clinical needs in skin diseases, supported by over 650 sales professionals covering more than 10,000 hospitals [5]

Core Viewpoint - Haitong International slightly adjusted the revenue forecast for Kangzheng Pharmaceutical (00867) for 2025-26E to 8.33/9.30 billion HKD, representing a year-on-year increase of 11.5%/11.6% [1] - The net profit forecast for the same period was adjusted to 1.67/1.88 billion HKD, reflecting a year-on-year growth of 3.4%/12.9% [1] - The valuation model was changed to a discounted cash flow (DCF) model to better reflect the long-term value of the pipeline cash flow from Demy Pharmaceutical, with a target price of 18.38 HKD (+85%) [1] Financial Performance - Kangzheng Pharmaceutical achieved a revenue of 4 billion HKD in the first half of the year, a year-on-year increase of 11% [2] - The revenue from major exclusive/brand products and innovative products was 2.9 billion HKD, up 21% year-on-year, which is the core driver of the company's performance recovery [2] - The gross profit margin was 72%, with R&D expenses of 570 million HKD (down 8% year-on-year) and a net profit of 940 million HKD (up 3% year-on-year) [2] Business Growth Drivers - The recovery in revenue is attributed to the clearance of the impact from existing centralized procurement products and the steady growth of core products such as Weifurui and Meitai Tong [3] - Exclusive/brand and innovative product sales accounted for 62.1% of total revenue, up from 56.1% in the same period last year [3] - Revenue by segment includes 2.2 billion HKD from cardiovascular, 1.4 billion HKD from digestive/immunity, 500 million HKD from skin health (up 104%), and 360 million HKD from ophthalmology [3] Innovation and Pipeline - The company has three NDA applications under review and approximately ten clinical trials progressing in China, including treatments for ischemic stroke and atopic dermatitis [4] - Potential products in development include Povorcitinib and CMS-D001, targeting various conditions [4] Spin-off Plans - Kangzheng Pharmaceutical plans to spin off Demy Pharmaceutical for independent listing on the Hong Kong Stock Exchange by April 2025 [5] - Demy Pharmaceutical's pipeline addresses significant unmet clinical needs in skin diseases and has over 650 sales professionals covering more than 10,000 hospitals [5]

Investment Rating - The report maintains an "Outperform" rating for the company with a target price of HK$18.38, representing an upside of 85% from the current price of HK$14.35 [2][7]. Core Insights - The company reported a net sales increase of CNY4 billion in 1H25, reflecting an 11% year-on-year growth, driven by strong sales of exclusive and innovative products, which accounted for CNY2.9 billion, a 21% increase year-on-year [3][13]. - The gross margin for the period was 72%, down 2.4 percentage points year-on-year, while net profit attributable to shareholders was CNY940 million, up 3% year-on-year [3][13]. - The recovery in main business growth is attributed to the sustained increase in sales of exclusive/branded and innovative products, with these products making up 62.1% of total revenue, up from 56.1% in 1H24 [4][15]. Financial Performance - Revenue projections for FY2025 and FY2026 are adjusted to CNY8.33 billion and CNY9.30 billion, respectively, indicating year-on-year growth of 11.5% and 11.6% [7][17]. - The net profit forecasts for FY2025 and FY2026 are revised to CNY1.67 billion and CNY1.88 billion, representing year-on-year growth of 3.4% and 12.9% [7][17]. - The company’s R&D expenses totaled CNY570 million, a decrease of 8% year-on-year, with an R&D expense ratio of 5.1% [3][13]. Product Pipeline and Developments - The company has three New Drug Applications (NDAs) under review, including Desidustat Tablets and Ruxolitinib Cream, with approximately ten clinical trials ongoing in China [5][15]. - The spin-off and independent listing of Dermavon Pharma is expected to be completed within the year, which will allow shareholders to directly hold shares in the new entity [5][16]. Segment Performance - Revenue by segment includes CNY2.2 billion from cardiovascular products (up 0.6% year-on-year), CNY1.4 billion from digestive/autoimmune products (up 4.9% year-on-year), and CNY500 million from skin health products (up 104% year-on-year) [19][14].