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].

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]

Summary of China Medical System Holdings (0867.HK) Conference Call Company Overview - **Company**: China Medical System Holdings (0867.HK) - **Industry**: Pharmaceuticals, specifically focusing on dermatology and ophthalmology Key Points 1. Sales Growth and Guidance - The company reported smooth commercialization progress in Q3 and maintained its guidance for over 10% sales growth for 2025/2026 driven by: - Further sales ramp-up of new products - Modest growth of Xinhuosu due to limited competition and unmet VBP threshold - Retail sales expansion for consumer-oriented products like Bioflor and Stulln - Stable sales for three key VBPed drugs - Earnings growth is expected to resume next year, targeting a net margin of over 25% in five years through an improved product mix and potential investment gains [2][4][8] 2. Ruxolitinib Cream Approval and Sales Target - Management anticipates that ruxolitinib cream will receive approval in China for vitiligo treatment by the end of 2025, with an unchanged sales target of RMB 500 million to 1 billion for 2026 [3][4] 3. New Ophthalmology Drugs - The company has secured commercial rights in China for two anti-VEGF drugs, Lucentis and Beovu, from Novartis, aiming for combined sales of RMB 500 million despite modest commercial potential due to biosimilar competition [4][7] 4. Financial Projections - The 12-month target price for the stock is set at HK$17.92, representing a 29.4% upside from the current price of HK$13.85. This target is based on a sum-of-the-parts (SOTP) valuation: - DCF-based valuation of RMB 12.0 billion for the dermatology business - DCF-based valuation of RMB 8.8 billion for other new drugs - 2026E P/E based valuation of RMB 20.1 billion for legacy products [8][9] 5. Risks - Potential risks include: - Greater-than-expected sales erosion of core VBP drugs - Softer growth of non-VBP legacy products - Slower ramp-up of new products [8] 6. Market Position and Strategy - The company aims to enhance its competitive position in the ophthalmology market through the introduction of new drugs and expanding sales channels to cover a broader patient base [4][7] 7. Financial Metrics - Market capitalization: HK$33.8 billion (approximately $4.3 billion) - Revenue projections for the next few years: - 2024: RMB 7,469 million - 2025: RMB 8,316 million - 2026: RMB 10,223 million - 2027: RMB 12,401 million - EBITDA and EPS projections also indicate growth [9] Conclusion China Medical System Holdings is on track for significant growth in the coming years, driven by new product launches and strategic partnerships. The company maintains a positive outlook for sales growth and profitability, although it faces certain market risks that could impact its performance.

Core Viewpoint - The Hong Kong Stock Connect Innovative Drug ETF (Southern, 159297) has shown significant market activity, with a recent increase of 3.38% and a trading volume of 170 million yuan, indicating strong investor interest in the innovative drug sector [1] Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (Southern, 159297) reached a new high in both scale and shares since its inception as of October 31 [1] - The ETF has experienced net inflows for 4 out of the last 5 trading days, totaling 18.9 million yuan [1] - The index it tracks, the National Certificate Hong Kong Stock Connect Innovative Drug Index, rose by 3.67%, with notable increases in component stocks such as Senhwa Biosciences (up 10.11%) and Kanglongda (up 8.80%) [1] Group 2: Policy and Industry Insights - The ongoing negotiations for the National Medical Insurance drug list are complemented by a new commercial health insurance innovative drug directory, aimed at providing new payment channels for high-value innovative drugs [1] - The CAR-T cell drug, Rukiyou Lunsai injection from WuXi AppTec, is making progress in negotiations to be included in the commercial health insurance innovative drug directory, with a listed price of 1.29 million yuan per injection [1] - Open Source Securities notes that the current innovative drugs included in both medical insurance and commercial insurance are in the early stages of volume growth, with potential for rapid revenue increases as policies continue to support innovative drugs [2] Group 3: Institutional Investment Trends - According to Guotou Securities, the proportion of all funds heavily invested in Biotech innovative drug companies has increased to 27.53%, reflecting a 2.61 percentage point rise, indicating growing institutional interest in the innovative drug sector [2] - The increasing allocation of funds to the innovative drug sector suggests a strong market recognition of its long-term development potential [2]

Group 1 - The Hong Kong Stock Connect innovative drug sector experienced a significant rebound on November 3, with the innovative drug ETF (520880) showing a volatility of over 4.4% and a trading volume exceeding 500 million yuan, indicating strong bullish sentiment [1] - Key stocks such as Kangfang Biotech, Xiansheng Pharmaceutical, and Kangnuo Ya-B saw increases of nearly 6%, while other companies like Yuanda Pharmaceutical and Rongchang Biotech also experienced substantial gains [1] - The National Medical Insurance negotiation, which began on October 30, is expected to conclude with results announced in early December, introducing a new "commercial insurance innovative drug catalog" mechanism for the first time [1] Group 2 - Fund manager Feng Chen indicated that the innovative drug market could see a resurgence, suggesting that now may be a high-probability period for medium to long-term investments in innovative drugs [2] - The recent meeting between US and Chinese leaders has alleviated previous risks that suppressed the sector's performance, potentially allowing previously withdrawn funds to re-enter the market [2] - The current earnings season has shown strong performance from companies like Innovent Biologics and Hengrui Medicine, boosting confidence in the sector [2] Group 3 - The Hong Kong Stock Connect innovative drug ETF (520880) passively tracks the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, which focuses entirely on innovative drug R&D companies, with over 70% of its holdings in large-cap innovative drug leaders [3] - As of the end of September, the index has seen a year-to-date increase of 108.14%, outperforming other innovative drug indices [3] - The ETF has a fund size of 1.806 billion yuan and an average daily trading volume of 493 million yuan, making it the largest and most liquid ETF tracking this index [3]

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 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10月31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 | | 0.005 USD | | 100,000,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 20,000,000,000 | USD | | 0.005 USD | | 100,000 ...