本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议，获得在 中国大陆、香港特别行政区、澳门特别行政区、臺湾地区及东南亚十一国(区域)研究、开发、注册及商 业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将 povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团(不包括德镁医药及其附属公司)。 本次该产品获纳入突破性治疗药物品种名单，有望加速其在中国大陆的研发与审评进程。若于中国获批 上市，该产品将有望与德镁医药在售创新药益路取(替瑞奇珠单抗注射液)、在售独家药喜辽妥(多磺酸粘 多糖乳膏)及正处于新药上市申请(NDA)阶段的创新药磷酸芦可替尼乳膏形成协同，推动产品快速实现 临床和商业价值，惠及更多皮肤疾病患者。此外，该产品还将与外用磷酸芦可替尼乳膏共同为白癜风患 者提供差异化、全面的治疗选择。 康哲药业(00867)发布公告，集团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)拥有相关许可权利的创新口服JAK1抑制剂 povorcitini ...

本次该产品获纳入突破性治疗药物品种名单，有望加速其在中国大陆的研发与审评进程。若于中国获批 上市，该产品将有望与德镁医药在售创新药益路取(替瑞奇珠单抗注射液)、在售独家药喜辽妥(多磺酸粘 多糖乳膏)及正处于新药上市申请(NDA)阶段的创新药磷酸芦可替尼乳膏形成协同，推动产品快速实现 临床和商业价值，惠及更多皮肤疾病患者。此外，该产品还将与外用磷酸芦可替尼乳膏共同为白癜风患 者提供差异化、全面的治疗选择。 本集团于2024年3月31日，通过德镁医药的附属公司与Incyte就povorcitinib订立合作和许可协议，获得在 中国大陆、香港特别行政区、澳门特别行政区、臺湾地区及东南亚十一国(区域)研究、开发、注册及商 业化产品的独家许可权利，以及在区域内生产产品的非独家许可权利。德镁医药的附属公司已将 povorcitinib除中国大陆外的其他区域的相关权利再许可予本集团(不包括德镁医药及其附属公司)。 智通财经APP讯，康哲药业(00867)发布公告，集团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)拥有相关许可权利的创新口服 JAK1抑制剂po ...

Core Viewpoint - Kangzheng Pharmaceutical (00867.HK) announced that its subsidiary, Demy Pharmaceutical Co., Ltd., is applying for an independent listing on the Hong Kong Stock Exchange, focusing on innovative medicines for skin health [1] Group 1: Clinical Trial Results - The Phase III clinical trial of the product, Lurcatinib Cream, for treating mild to moderate Atopic Dermatitis (AD) in China has shown positive results [1] - The trial involved 192 patients and was a randomized, double-blind, placebo-controlled, multi-center study led by Shanghai Skin Disease Hospital [1] - The primary endpoint was significantly achieved, with 63.0% of patients treated with Lurcatinib Cream reaching an Investigator's Global Assessment (IGA) score of 0 or 1 after 8 weeks, compared to 9.2% in the placebo group (P<0.001) [2] - A key secondary endpoint was also met, with 78.0% of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI75) score, compared to 15.4% in the placebo group (P<0.001) [2] Group 2: Safety and Tolerability - The treatment was generally well-tolerated, with most treatment-emergent adverse events (TEAEs) being mild or moderate in severity [2] - No TEAEs led to the discontinuation of the study drug, indicating good overall safety and tolerability [2]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 has achieved positive results in a Phase III clinical trial for its product,芦可替尼乳膏, targeting mild to moderate atopic dermatitis (AD) in China, and is moving forward with its new drug application (NDA) process [1][2]. Group 1: Clinical Trial Results - The Phase III trial involved 192 patients and was a randomized, double-blind, placebo-controlled, multi-center study conducted in China [1]. - The primary endpoint was met, with 63.0% of patients treated with芦可替尼乳膏 achieving an Investigator's Global Assessment (IGA) score of 0 or 1, and a ≥2 point improvement from baseline, significantly higher than the 9.2% in the placebo group (P<0.001) [2]. - A key secondary endpoint showed that 78.0% of patients treated with芦可替尼乳膏 achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI 75) score, compared to 15.4% in the placebo group (P<0.001) [2]. Group 2: Safety and Tolerability - The majority of treatment-emergent adverse events (TEAEs) during the trial were mild to moderate, with no serious adverse events leading to discontinuation of the study drug [2]. - Overall, the safety and tolerability of芦可替尼乳膏 were deemed good [2]. Group 3: Regulatory Progress - The company is actively advancing the new drug application (NDA) process for芦可替尼乳膏 in China [2].

Core Viewpoint - Hunan Maijibio Technology Co., Ltd. has submitted an application for a main board listing on the Hong Kong Stock Exchange, focusing on innovative biopharmaceuticals for allergic and autoimmune diseases, but faces significant challenges including zero commercialization of products, ongoing substantial losses, high debt ratios, patent disputes, and intense competition in its sector [1][2][4]. Company Overview - Established in 2016, Maijibio specializes in developing innovative therapies for allergic and autoimmune diseases through bioreagent technology, with a pipeline of 8 candidate products, including MG-K10, which is in phase III clinical trials [2][3]. - The company reported negligible revenues of 8.72 million yuan, 24,000 yuan, and 0 yuan for 2023, 2024, and Q1 2025 respectively, all from early-stage R&D service collaborations, with no products approved for market sale [2][3]. Financial Performance - Maijibio has incurred net losses of 253 million yuan, 178 million yuan, and 27.27 million yuan for the years 2023, 2024, and Q1 2025, respectively, with cumulative losses exceeding 800 million yuan by March 2025 [2][3]. - The company's debt ratio has been over 100% for an extended period, peaking at nearly 700% at the end of 2023, and still standing at 166.83% by March 2025, indicating severe financial distress [2][3]. R&D and Market Potential - The R&D expenditures for 2023 and 2024 are projected to be 166 million yuan and 150 million yuan, respectively, with the company relying heavily on external financing due to a lack of self-sustaining revenue [3]. - The IL-4Rα targeted therapy market is projected to reach 4.08 billion USD in China by 2030, attracting numerous competitors, including domestic players who have already launched products [6][7]. Competitive Landscape - Maijibio's MG-K10 is a latecomer in a crowded market, facing competition from over 10 companies, including those with products already in late-stage clinical trials [7]. - The company has partnered with Kangzhe Pharmaceutical for the joint development and exclusive commercialization of MG-K10, which provides financial support but also raises concerns about potential internal competition due to overlapping product lines [7][8]. Legal and Governance Issues - The core product MG-K10 has been embroiled in a patent ownership dispute, which raises questions about the originality and independence of its technology [4]. - The founder's salary has seen a dramatic increase from 5.469 million yuan in 2023 to 18.08 million yuan in 2024, contrasting sharply with the company's financial struggles [5]. Investment and Financing - Maijibio has completed seven rounds of financing, raising approximately 730 million yuan, with significant investments from notable institutions [8]. - The company has entered into strict agreements with investors, allowing them to demand share buybacks if the company fails to go public by the end of 2025, with potential repercussions extending to 2027 [9].

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。 *僅供識別 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 獲得白癜風、化膿性汗腺炎適應症藥物臨床試驗批准通知書 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企 業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公司日期為二零二五年四 月二十二日發佈的公告）連同其附屬公司於二零二五年八月二十七日獲中國國家藥品監 督管理局（NMPA）簽發的藥物臨床試驗批准通知書，於八月二十八日收到藥物臨床試 驗批准通知書。NMPA同意開展povorcitinib（擬定中文通用名：磷酸泊沃昔替尼片） （「povorcitinib」或「產品」）用於非節段型白癜風和中重度化膿性汗腺炎（HS）的臨 床試驗。 Povorcitinib 是一種選擇性口服小 ...

Core Insights - The article highlights the increasing cross-border flow of people between Hong Kong and Shenzhen, particularly through the Luohu and Liantang ports, which has led to new economic opportunities in the region [1][2][4] Group 1: Cross-Border Traffic and Economic Opportunities - In the first half of the year, over 33.7 million travelers passed through the Luohu port, making it the busiest port in Shenzhen [1] - The Luohu district is becoming a primary destination for Hong Kong residents, with approximately 30% of the overall foot traffic in local shopping centers coming from Hong Kong visitors [4] - The establishment of the "B1" land plot near Luohu port aims to create a 300,000 square meter health industry park, enhancing the region's industrial structure [2][12] Group 2: Consumer Behavior and Preferences - Hong Kong residents are expanding their consumption patterns in Shenzhen beyond dining to include shopping and healthcare services [4][6] - The newly opened Yitian Holiday Plaza has attracted Hong Kong customers with diverse dining options, accounting for 40% of its offerings [4] - The demand for high-quality shopping and family-friendly activities is growing among Hong Kong visitors, indicating a shift in their lifestyle preferences [6][8] Group 3: Healthcare Integration - The number of Hong Kong patients seeking medical services in Shenzhen has significantly increased, with an average of 4,500 Hong Kong patients visiting the Luohu District People's Hospital monthly [7][10] - A recent survey indicated that 60% of Hong Kong residents have utilized medical services in mainland China, a tenfold increase since 2011 [8] - The Luohu District People's Hospital has become a designated medical institution for cross-border drug and medical device use, facilitating quicker access to new treatments for patients [10][11] Group 4: Strategic Development and Collaboration - The development of the Northern Metropolis in Hong Kong aims to enhance economic collaboration with Shenzhen, focusing on trade, finance, and emerging industries [12][13] - The integration of industries between Hong Kong and Luohu is being actively promoted, with plans to establish a cross-border cooperation platform for traditional and Western medicine [10][16] - The ongoing upgrades of industrial zones and the establishment of a health industry park reflect a strategic alignment in industrial direction between Hong Kong and Luohu [14][16]

Core Insights - The cross-border flow between Shenzhen and Hong Kong is experiencing unprecedented growth, with over 33.7 million travelers recorded at the Luohu port in the first half of the year, making it the busiest port in Shenzhen [1] - The Luohu district is evolving into a hub for Hong Kong residents, expanding their consumption patterns from basic needs to healthcare and leisure activities [2][3] - The establishment of the Shenzhen-Hong Kong Life and Health Industry Park is set to enhance the industrial structure of Luohu, focusing on emerging sectors like artificial intelligence and life sciences [1][9] Cross-Border Consumption Trends - Hong Kong residents are increasingly frequenting Luohu for various services, with approximately 30% of the overall foot traffic in shopping malls attributed to them [2] - The demand from Hong Kong consumers is diversifying, with older demographics seeking high-quality shopping experiences and families looking for child-friendly entertainment options [3] - The Luohu district is planning events such as cycling and esports to attract Hong Kong residents and showcase its cultural and recreational offerings [4] Healthcare Integration - The number of Hong Kong patients visiting Luohu hospitals has expanded beyond dental care, with an average of 4,500 Hong Kong patients treated monthly across various departments [5][6] - A significant increase in Hong Kong residents utilizing mainland medical services has been observed, with 60% reported in a recent study, marking a tenfold increase since 2011 [5] - The establishment of cross-border medical collaborations and the introduction of Hong Kong medical products in Luohu hospitals are enhancing healthcare accessibility for both Hong Kong and mainland patients [6][7] Industrial Development and Collaboration - The North Metropolitan Area development strategy emphasizes the integration of industries between Hong Kong and Shenzhen, with Luohu positioned as a key player in this initiative [7][8] - Luohu's industrial planning aligns with the North Metropolitan Area's goals, focusing on sectors such as artificial intelligence, life sciences, and low-altitude economy [8][9] - The B1 land plot near Luohu port is being developed into a life and health industry park, aiming to attract leading research institutions and industry leaders for cross-border collaboration [9]

Core Viewpoint - The article discusses the development of the Luohu district as a "super node" for cross-border economic activities between Shenzhen and Hong Kong, highlighting the increasing flow of people and the expansion of consumption and medical services in the area [1][2][7]. Group 1: Cross-Border Traffic and Economic Opportunities - The Luohu port has seen over 33.7 million inbound and outbound travelers in the first half of the year, making it the busiest port in Shenzhen [1] - The daily traffic at Luohu port reached a record high of 297,000 on July 13, indicating a strong recovery in cross-border travel [2] - Hong Kong residents account for approximately 30% of the overall foot traffic in local shopping malls, with a significant portion of the retail space catering to their preferences [2][3] Group 2: Healthcare Expansion - The number of Hong Kong patients visiting Luohu hospitals has diversified beyond dental care, with an average of 4,500 Hong Kong patients visiting the Luohu District People's Hospital each month [5] - A survey indicated that 60% of Hong Kong residents have utilized medical services in mainland China from 2019 to 2023, a tenfold increase since 2011 [5] - The Luohu District People's Hospital has been approved as a designated medical institution for "Hong Kong and Macau drug and device access," facilitating the introduction of new medical products [5][6] Group 3: Industrial Development and Strategic Planning - Luohu aims to transform its industrial structure by focusing on emerging sectors such as artificial intelligence and life sciences, with plans for a 300,000 square meter life health industrial park [1][8] - The "Northern Metropolis Development Strategy" emphasizes the integration of Hong Kong's economy with Shenzhen, particularly in the Luohu area, which is set to become a hub for trade and new industries [6][7] - The development of the B1 plot near Luohu port is expected to create a cross-border cooperation platform for life sciences and AI, enhancing the region's innovation capabilities [8]

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].