Core Insights - The pancreatic cancer drug market is projected to surge tenfold to nearly $5 billion by 2035, primarily driven by advancements from Revolution Medicines [3][4] - Despite pancreatic cancer accounting for only 3% of all tumor cases in Western countries, it represents 8% of cancer deaths due to late diagnosis and lack of effective treatments [3] Market Growth Potential - The pancreatic cancer drug market is expected to grow from nearly zero to approximately $5 billion in the next decade, led by Revolution Medicines' pan-RAS inhibitor darasofit [4] - The drug is anticipated to be applicable to over 90% of patients, while competitors like Incyte are developing KRAS G12D selective drugs targeting 35% of patients [4] - Innovations in PRMT5 inhibitors by companies like Bristol-Myers Squibb are also expected to contribute to market growth [4] Disease Statistics - In 2024, an estimated 510,000 new cases of pancreatic cancer are expected globally, ranking as the 12th most common malignancy but the sixth leading cause of cancer death [6] - The incidence of pancreatic ductal adenocarcinoma (PDAC) is rising, driven by aging populations and increasing risk factors such as obesity and diabetes [6] - PDAC accounts for 95% of all pancreatic cancer cases, with a significant portion of patients being over 65 years old [6] Survival Rates and Challenges - PDAC remains one of the deadliest cancers, with a five-year survival rate of only 13% and a median survival of about four months [8] - Late diagnosis is a major issue, with around 60% of cases diagnosed at an advanced stage due to vague symptoms [8] - The lack of effective screening methods contributes to the high mortality rate, as only 10%-20% of patients are eligible for surgical intervention [10] Treatment Landscape - Chemotherapy remains the standard treatment across all stages, with limited efficacy in advanced cases [10] - The expected survival for patients receiving first-line treatment is less than 12 months, and second-line treatment further reduces survival [10] - There is significant potential for innovation in PDAC treatment, particularly with the development of drugs targeting previously "undruggable" oncogenic drivers like KRAS [10]

Investment Rating - The report assigns a positive outlook on China Medical System Holdings, indicating a potential for significant revenue growth from the newly approved ruxolitinib cream [1][3]. Core Insights - The approval of ruxolitinib cream for treating non-segmental vitiligo is expected to drive substantial sales growth, with management projecting revenues of at least CNY 500 million in 2026 and doubling in 2027, reaching a peak of no less than CNY 6 billion within 4-5 years [3][11]. - The cream is positioned to fill a market gap due to the limitations of existing therapies for vitiligo, with a strong demand from patients willing to pay for better efficacy and fewer side effects [4][12]. - The company has initiated pilot applications of the cream in Hainan, with over 7,700 patients already using it before formal approval, indicating strong early adoption [2][10]. Summary by Sections Product Approval and Market Strategy - On January 30, the company’s subsidiary Dermavon received approval from the NMPA for ruxolitinib cream, which is an innovative formulation for treating non-segmental vitiligo in patients aged 12 and above [1][8]. - The company has established exclusive rights for the development and commercialization of the product in several regions, including Mainland China and Southeast Asia [1][8]. Market Potential and Revenue Projections - Management anticipates that the cream will generate revenues of at least CNY 500 million in 2026, with expectations to double in 2027 and reach a peak revenue of no less than CNY 6 billion [3][11]. - The pricing strategy indicates that the listed price will be lower than the previous pilot price of CNY 6,800 per tube [3][11]. Competitive Landscape - Existing treatments for vitiligo have clinical limitations, and ruxolitinib cream is expected to provide a more effective solution, particularly for patients with facial involvement [4][12]. - The cream's efficacy has been supported by real-world data from the Hainan pilot zone, aligning with international clinical study results [4][12]. Future Developments - The company is also focusing on the potential use of ruxolitinib cream for mild-to-moderate atopic dermatitis, with plans to submit a marketing application soon [4][13].

[Table_Title] 研究报告 Research Report 2 Feb 2026 康哲药业 China Medical System Holdings (867 HK) [Table_yemei1] 热点速评 Flash Analysis [Table_summary] (Please see APPENDIX 1 for English summary) 事件 1 月 30 日，康哲药业子公司德镁医药，获得中国国家药品监督管理局（NMPA）批准磷酸芦可替尼乳膏新药上市许 可申请，用于治疗 12 岁及以上儿童和成人患者伴面部受累的非节段型白癜风。芦可替尼乳膏（Opzelura®）是 Incyte 开发的选择性 JAK1/JAK2 抑制剂芦可替尼制成的一种创新型乳膏。2022 年 12 月，德镁医药与 Incyte 就芦可 替尼乳膏订立许可协议，获得在中国大陆、香港特别行政区、澳门特别行政区、台湾地区及东南亚十一国研发、 注册及商业化产品的独家许可权利，以及生产产品的非独家许可权利。 重磅品种芦可替尼获批上市，未来增长可期 Blockbuster Drug Ruxolitinib Cream Appr ...

消息面上，近日，康哲药业发布公告，旗下德镁医药有限公司("德镁医药"，专业聚焦皮肤健康的创新 型医药企业，正申请于香港联合交易所有限公司主板独立上市，)已于2026年1月30日获得中国国家药品 监督管理局(NMPA)批准磷酸芦可替尼乳膏(白癜风适应症)新药上市许可申请(NDA)。产品用于治疗12岁 及以上儿童和成人患者伴面部受累的非节段型白癜风，是中国批准的首款且唯一用于白癜风治疗的靶向 药，满足巨大未被满足的临床需求。 中金指出，芦可替尼乳膏是Incyte开发的JAK1/JAK2抑制剂，也是经FDA批准的首款且唯一用于非节段 型白癜风复色药物。根据公告公司估算，中国约1030万人患有白癜风(820万人患有非节段性白癜风)， 现有TCS/TCIs治疗存在临床缺陷，长期用药具有不良反应或疗效有限，该行认为芦可替尼乳膏国内获 批有望填补白癜风靶向治疗空白，满足临床未被满足需求。 康哲药业(00867)涨超3%，截至发稿，涨3.14%，报14.47港元，成交1838.61万港元。 ...

中金指出，芦可替尼乳膏是Incyte开发的JAK1/JAK2抑制剂，也是经FDA批准的首款且唯一用于非节段 型白癜风复色药物。根据公告公司估算，中国约1030万人患有白癜风(820万人患有非节段性白癜风)， 现有TCS/TCIs治疗存在临床缺陷，长期用药具有不良反应或疗效有限，该行认为芦可替尼乳膏国内获 批有望填补白癜风靶向治疗空白，满足临床未被满足需求。 消息面上，近日，康哲药业发布公告，旗下德镁医药有限公司("德镁医药"，专业聚焦皮肤健康的创新 型医药企业，正申请于香港联合交易所有限公司主板独立上市，)已于2026年1月30日获得中国国家药品 监督管理局(NMPA)批准磷酸芦可替尼乳膏(白癜风适应症)新药上市许可申请(NDA)。产品用于治疗12岁 及以上儿童和成人患者伴面部受累的非节段型白癜风，是中国批准的首款且唯一用于白癜风治疗的靶向 药，满足巨大未被满足的临床需求。 智通财经APP获悉，康哲药业(00867)涨超3%，截至发稿，涨3.14%，报14.47港元，成交1838.61万港 元。 ...

Core Opinion - The article highlights the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding Zynyz® (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC) [1] Company Summary - The company, Incyte, is advancing its product Zynyz® (retifanlimab) in the oncology space, specifically targeting advanced SCAC [1] Industry Context - The approval of Zynyz® could potentially impact treatment options in the oncology market, particularly for patients with advanced SCAC, indicating a significant development in cancer therapeutics [1]

Core Viewpoint - China Medical System Holdings Limited's subsidiary, Dermavon Holdings Limited, received approval for ruxolitinib phosphate cream, the first targeted drug for non-segmental vitiligo in China, addressing a significant unmet clinical need for over 10 million patients [1][4]. Group 1: Product Approval and Market Potential - Ruxolitinib phosphate cream is the first drug approved by both the U.S. FDA and the European Medicines Agency for repigmentation in non-segmental vitiligo [2]. - The product has been prescribed to over 7,000 patients at Boao Super Hospital and is available in more than twenty hospitals across major cities in China, indicating strong clinical demand [2]. - The approval is expected to enhance Dermavon's product portfolio in skin treatment, potentially synergizing with existing products like ILUMETRI and Hirudoid [4]. Group 2: Clinical Efficacy and Safety - In overseas Phase III clinical studies, 29.9% of patients achieved at least 75% improvement in the Facial Vitiligo Area Score Index after 24 weeks of treatment, compared to 7.5% and 12.9% in placebo groups [3]. - Real-world studies in China showed consistent positive efficacy with no new safety events reported, indicating a favorable safety profile for the product [3]. Group 3: Future Developments - The Phase III clinical trial for ruxolitinib phosphate cream in treating mild to moderate atopic dermatitis has also shown positive results, with an NDA actively being pursued for this indication [5]. - The approval of ruxolitinib phosphate cream fills a significant gap in targeted treatment options for vitiligo, which affects approximately 10.3 million patients in China [6].

磷酸芦可替尼乳膏(Opzelura®)是Incyte开发的选择性JAK1/JAK2抑制剂芦可替尼制成的一种创新型乳 膏，是经美国食品和药物管理局(FDA)批准的首款且唯一用於非节段型白癜风复色的药物。在美国，磷 酸芦可替尼乳膏可用於局部治疗成人及12岁及以上患者的非节段型白癜风，及2岁及以上非免疫力功能 低下患者的轻度至中度特应性皮炎(AD)的局部短期和非连续性慢性治疗。在欧洲，磷酸芦可替尼乳膏 被批准用于治疗成年及12岁及以上青少年面部受累的非节段型白癜风。 格隆汇1月30日丨康哲药业(00867.HK)宣布，旗下德镁医药有限公司("德镁医药"，专业聚焦皮肤健康的 创新型医药企业，正申请于香港联合交易所有限公司主板独立上市，已于2026年1月30日获得中国国家 药品监督管理局(NMPA)批准磷酸芦可替尼乳膏(白癜风适应症)("产品")新药上市许可申请(NDA)。产品 用于治疗12岁及以上儿童和成人患者伴面部受累的非节段型白癜风，是中国批准的首款且唯一用于白癜 风治疗的靶向药，满足巨大未被满足的临床需求。 ...

自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏中國上市許可申請獲批 為中國批准的首款且唯一用於白癜風治療的靶向藥 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 在產品正式獲得NDA批准之前，本集團受益於國家賦予海南自由貿易港及樂城先行區 （「樂城先行區」）「先行先試」政策、「港澳藥械通」政策、北京市及天津自貿試驗 區的臨床急需進口藥品政策，已啟動磷酸蘆可替尼乳膏的試點應用。目前博鰲超級醫院 已為超7,000名非節段型白癜風患者開具磷酸蘆可替尼乳膏處方，且廣州、深圳、東莞、 佛山、中山、珠海、江門、惠州、北京及天津共二十餘家醫院已提供該藥品處方服務。 磷酸蘆可替尼乳膏在境外開展的兩項相同設計的III期雙盲、隨機、安慰劑對照研究 （TRuE-V1和TRuE-V2）中，產品治療 ...

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market engagement and confidence [1][2] Zacks Style Scores - Zacks Style Scores rate stocks based on value, growth, and momentum, serving as complementary indicators to the Zacks Rank [3] - Stocks receive an alphabetic rating from A to F, with A indicating the highest potential for outperforming the market [4] Value Score - The Value Style Score focuses on identifying undervalued stocks using ratios like P/E, PEG, and Price/Sales [4] Growth Score - The Growth Style Score evaluates stocks based on projected and historical earnings, sales, and cash flow to identify sustainable growth opportunities [5] Momentum Score - The Momentum Style Score assesses stocks based on price trends and earnings outlook changes, helping investors capitalize on upward or downward price movements [6] VGM Score - The VGM Score combines all three Style Scores, providing a comprehensive indicator for investors who utilize multiple investing strategies [7] Zacks Rank and Style Scores - The Zacks Rank is a proprietary model that leverages earnings estimate revisions to guide investors in portfolio creation [8] - Stocks rated 1 (Strong Buy) have historically produced an average annual return of +23.83% since 1988, significantly outperforming the S&P 500 [9] Stock Selection Strategy - For optimal returns, investors should focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B [10] - Stocks with a 3 (Hold) rank should also have Style Scores of A or B to maximize upside potential [10] Company Spotlight: Incyte Corporation - Incyte Corporation, based in Wilmington, DE, is a biopharmaceutical company engaged in developing proprietary therapeutics [12] - Currently rated 3 (Hold) with a VGM Score of A, Incyte has a Momentum Style Score of A and has seen a 1.9% increase in shares over the past four weeks [12][13] - The earnings estimate for fiscal 2025 has been revised upwards, with the Zacks Consensus Estimate now at $6.88 per share, reflecting an average earnings surprise of +14.4% [13]