摘要 康哲药业 2025 年实现正增长，毛利率和净利润改善，预计全年收入和 利润增长趋势明显。创新药商业化和国际化是未来主要增长驱动力，已 有五款创新药商业化，六款产品处于 NDA 阶段，数十项产品在临床阶段。 公司预计 2025-2027 年归母净利润分别为 16.5 亿元、19.6 亿元和 22.7 亿元，实现稳健增长。公司早期为 CSO 平台，后转型关注产品创 新、国际化及商业革新，2024 年进入创新产品商业化元年。 公司产品线包括存量国产品、独家或品牌产品及创新药。五款创新药自 2023 年陆续上市，预计 2025 年合计收入翻倍。研发管线丰富，包括 NDA 阶段及临床三期阶段的多项重磅新品。 心脑血管领域核心产品包括波依定、达力新、新活素等，总销售收入约 30 多亿元。维福瑞和维妥可表现突出，实现快速增长。德西杜斯塔片及 治疗 AD 等相关疾病的新疗法将丰富治疗方案。 创新药维福瑞用于透析后高磷血症，患者接受度高，副作用少，峰值销 售额有望超 20 亿元。注射用 Y3 治疗缺血性脑卒中，预防卒中后抑郁和 焦虑，预计峰值销售额可达 20-30 亿元。 Q&A 康哲药业在 2025 年上半年的业绩表现 ...

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].

Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit for 2025-2027 to be CNY 1.661 billion, CNY 1.917 billion, and CNY 2.272 billion, representing year-on-year growth of 2.54%, 15.39%, and 18.57% respectively, maintaining a "Buy" rating [1] Group 1: Financial Performance - In the first half of 2025, the company's revenue reached CNY 4.002 billion, a year-on-year increase of 10.8%, with pharmaceutical sales contributing CNY 4.670 billion, up 8.9% [2] - The net profit attributable to shareholders was CNY 941 million, reflecting a 3.4% year-on-year growth, with a gross margin of 61.7% and a sales expense ratio of 30.3%, down 2.1 percentage points [2] - The company declared an interim dividend of CNY 0.1555 per share, totaling CNY 376 million, which accounts for approximately 39.99% of the net profit for the first half of 2025 [2] Group 2: Growth Drivers - The negative impact of national procurement on operating performance has diminished, with major exclusive, branded, and innovative products continuing to drive sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from the cardiovascular disease segment was CNY 2.216 billion, up 0.6%, while the digestive and autoimmune disease segment generated CNY 1.411 billion, a 4.9% increase; the skin health segment (Demei Pharmaceutical) saw revenue of CNY 498 million, up 104.3% [3] Group 3: Innovation and Product Development - The company has accelerated its innovation strategy since 2025, with five approved innovative drugs (Yiluqu, Weifurui, Meitai Tong, Weituo Ke, Laifulan) set to release commercial value [4] - Three innovative drugs are under NDA review in China, and two self-developed products have received IND approval, alongside two newly developed collaborative innovative products [4] - A new injectable product (Lizhenran) was approved in China in July 2025 [4] Group 4: Strategic Initiatives - The company plans to spin off its skin health business, Demei Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages, covering major skin disease treatments [5] - Additionally, two skincare products aimed at disease prevention and care have been launched [5]

Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit attributable to shareholders to reach 1.661 billion yuan, 1.917 billion yuan, and 2.272 billion yuan for 2025-2027, with corresponding growth rates of 2.54%, 15.39%, and 18.57% respectively, maintaining a "buy" rating [1] Group 1 - In the first half of 2025, the company's revenue was 4.002 billion yuan, a year-on-year increase of 10.8%, with a profit attributable to shareholders of 941 million yuan, up 3.4% [2] - The gross margin for drug sales was 61.7%, with a sales expense ratio of 30.3%, down 2.1 percentage points, and a management expense ratio of 9.2%, up 0.8 percentage points [2] - The company declared an interim dividend of 0.1555 yuan per share, totaling 376 million yuan, which accounts for approximately 39.99% of the net profit attributable to shareholders for the first half of 2025 [2] Group 2 - The negative impact of national procurement on operating performance has passed, with major exclusive and innovative products driving sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from cardiovascular-related products was 2.216 billion yuan, up 0.6%; revenue from digestive/immunology-related products was 1.411 billion yuan, up 4.9%; revenue from skin health products was 498 million yuan, up 104.3%; and revenue from ophthalmology products was 358 million yuan, up 17.7% [3] Group 3 - The company has accelerated its innovation efforts in 2025, with five approved innovative drugs expected to release commercial value, and three innovative drugs currently under NDA review in China [4] - Two self-developed products have received IND approval, and two new collaborative innovative products have been added [4] - A new injectable product has been approved in China as of July 2025 [4] Group 4 - The company plans to spin off its skin health business, Dermy Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages as of the first half of 2025 [5] - Dermy Pharmaceutical has also launched two skincare product lines aimed at preventing and treating skin diseases [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 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]

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].

Investment Rating - The investment rating for the company is "Buy" [1] Core Views - The company has shown continuous growth in innovative products, with a notable performance in the skin health line [4] - The company reported a revenue of 4.002 billion yuan in the first half of 2025, representing a year-on-year increase of 10.8%, and a net profit attributable to shareholders of 941 million yuan, up 3.38% [5] - The sales of exclusive/brand and innovative products increased by 20.6% year-on-year, accounting for 62.1% of total revenue [5] - The company is advancing its innovative drug pipeline, with several products in various stages of clinical trials [5] - The skin health line (Demeg Pharmaceuticals) achieved a revenue of 498 million yuan, a significant increase of 104.3% [5] - The company plans to spin off Demeg Pharmaceuticals for independent listing, which is expected to help in the revaluation of its skin care product line [5] - Revenue forecasts for 2025 to 2027 are 8.053 billion yuan, 9.439 billion yuan, and 11.651 billion yuan, with corresponding net profits of 1.685 billion yuan, 1.956 billion yuan, and 2.465 billion yuan [6] Summary by Sections Company Overview - The company is focused on innovative pharmaceuticals, particularly in cardiovascular, central nervous system, digestive, and renal fields [5] Financial Performance - The company’s current P/E ratio is 18.12, with a market capitalization of 32.787 billion HKD [5] - The projected revenue growth rates for 2025, 2026, and 2027 are 7.8%, 17.2%, and 23.4% respectively [6] Product Pipeline - The company has a robust pipeline with several innovative drugs under development, including those for chronic kidney disease and asthma [5] Market Position - The company has established a strong market presence with a comprehensive product matrix and experienced commercialization capabilities [5]

Core Viewpoint - 康哲药业 reported a revenue of 40.02 billion yuan for the first half of 2025, representing a year-on-year increase of 10.83%, and a net profit of 9.41 billion yuan, up 3.38% year-on-year, indicating positive growth in both revenue and profit [1] Financial Performance - The company's expense ratio was 56.75%, an increase of 1.52 percentage points year-on-year; gross margin was 72.26%, down 2.41 percentage points year-on-year; R&D expenses reached 2.02 billion yuan, up 91.79% year-on-year, with an R&D expense ratio of 5.06%, up 2.14 percentage points year-on-year [1] - Sales expense ratio was 35.59%, down 3.19 percentage points year-on-year; management expense ratio was 15.82%, up 2.89 percentage points year-on-year; financial expense ratio was 0.28%, down 0.32 percentage points year-on-year [1] Business Segments - Traditional business in cerebrovascular disease generated sales of 22.16 billion yuan, up 0.6% year-on-year, accounting for 47.5% of total sales; sales from digestive and autoimmune disease lines were 14.11 billion yuan, up 4.9% year-on-year, accounting for 30.2% [1] - New business in dermatology and aesthetics (德镁医药) achieved sales of 4.98 billion yuan, up 104.3% year-on-year, accounting for 10.7%; ophthalmology sales were 3.58 billion yuan, up 17.7% year-on-year, accounting for 7.7% [1] - The company has five innovative drugs commercialized, including 莱芙兰, 美泰彤, 维福瑞, 益路取, and 维图可, with rapid commercialization progress [1] Product Development - Three products are currently under NDA review: 德昔度司他片 for anemia treatment in CKD patients, 芦可替尼乳膏 for vitiligo, and ZUNVEYL for Alzheimer's disease [2] - Two self-developed innovative drugs have received IND approval and are set to begin clinical trials: CMS-D001片 for psoriasis and CMS-D003胶囊 for obstructive hypertrophic cardiomyopathy [2] International Expansion - The company is in the process of splitting 德镁健康 for independent listing on the Hong Kong Stock Exchange, enhancing its position in the dermatology sector [3] - 康哲药业 is advancing its international commercial system, with a focus on Singapore as a regional hub, and has submitted product registration applications in several Southeast Asian countries [3] Investment Outlook - Revenue projections for 康哲药业 from 2025 to 2027 are 83.20 billion yuan, 94.54 billion yuan, and 110.43 billion yuan, with year-on-year growth rates of 11%, 14%, and 17% respectively; net profit estimates are 16.28 billion yuan, 18.92 billion yuan, and 22.52 billion yuan, with growth rates of 0%, 16%, and 19% respectively [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a revenue of 4.002 billion HKD for the first half of 2025, representing a year-on-year increase of 10.83%, and a net profit attributable to shareholders of 941 million HKD, up 3.38% year-on-year, indicating a recovery in profits after two years of stagnation [4][10] - The sales of exclusive/brand and innovative products continued to grow, accounting for 62.1% of total revenue, up from 56.1% in the same period last year [4] Summary by Sections Financial Performance - The company’s total revenue for the reporting period was 4.002 billion HKD, with a year-on-year growth of 10.83% - The net profit attributable to shareholders was 941 million HKD, reflecting a year-on-year increase of 3.38% - The gross profit margin was 72.26%, down 2.41 percentage points year-on-year, primarily due to changes in product mix and increased investment in R&D [5][10] R&D and Innovation - R&D expenses increased significantly by 91.79% to 202 million HKD, with an R&D expense ratio of 5.06%, up 2.14 percentage points year-on-year [5] - The company has five innovative drugs that have entered commercialization, with rapid progress in their commercialization [6] Business Segments - Traditional business lines, such as cerebrovascular disease, generated sales of 2.216 billion HKD, up 0.6%, while the digestive and autoimmune disease lines saw sales of 1.411 billion HKD, up 4.9% [6] - New business segments, particularly the dermatology and aesthetic line (De Mei Health), reported sales of 498 million HKD, a remarkable increase of 104.3% [6] Future Catalysts - Several products are in the NDA/IND review stage, with two self-developed innovative drugs having received IND approval and set to begin clinical trials [7][8] - The company is in the process of splitting De Mei Health for independent listing, which is expected to enhance its market position [9] Financial Projections - Revenue projections for 2025-2027 are 8.32 billion HKD, 9.454 billion HKD, and 11.043 billion HKD, with expected year-on-year growth rates of 11%, 14%, and 17% respectively [10] - Net profit projections for the same period are 1.628 billion HKD, 1.892 billion HKD, and 2.252 billion HKD, with expected growth rates of 0%, 16%, and 19% respectively [10]

Core Viewpoint - 康哲药业 reported a significant recovery in its operating performance for the first half of 2025, driven by the end of negative impacts from national procurement policies and sustained growth in exclusive/brand and innovative product sales, which now account for 62.1% of total revenue [1][2]. Financial Performance - The company's revenue increased by 10.8% year-on-year to RMB 4.002 billion, with a drug sales revenue growth of 8.9% to RMB 4.67 billion [1]. - Gross profit rose by 7.2% to RMB 2.892 billion, with drug sales gross profit also increasing by 7.2% to RMB 2.882 billion [1]. - Net profit attributable to shareholders grew by 3.1% to RMB 931.5 million, with earnings per share at RMB 0.3892 and an interim dividend of RMB 0.1555 per share declared [1]. Product and Market Development - The company has a pipeline of approximately 40 differentiated innovative products, with 5 innovative drugs already approved in China and commercialized [3]. - The sales of exclusive/brand and innovative products have shown a significant increase, contributing to the overall revenue growth [2]. - The company is focusing on specialized areas, with its skin health brand "德镁医药" becoming a leading innovative pharmaceutical company in China, planning to list independently on the Hong Kong Stock Exchange [2]. Strategic Initiatives - 康哲药业 is pursuing an internationalization strategy, having completed a secondary listing on the Singapore Exchange in July 2025, which is expected to enhance its brand influence in Southeast Asia and international markets [2]. - The company is actively advancing its research and development efforts, with around 20 self-developed projects progressing steadily, and 5 projects entering clinical development stages [3].