产品拟用于其他外用药控制不佳或不建议使用时，非免疫功能受损的2岁及以上儿童和成人轻中度特应 性皮炎的局部短期和非持续性慢性治疗。且该项NDA因「符合儿童生理特徵的儿童用药品新品种、剂 型和规格」，已获得NMPA药品审评中心批准纳入优先审评品种名单，有望加快产品AD适应症上市审 评进程。此外，磷酸芦可替尼乳膏已于2026年1月获得NMPA批准上市，成为中国批准的首款且唯一用 于白癜风治疗的靶向药。此次增加AD适应症NDA获受理，是产品向多治疗领域拓展的关键里程碑。 格隆汇2月24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，详见公司日期为2025年4月22日 发布的公告)已于2026年2月24日获得中国国家药品监督管理局(NMPA)受理磷酸芦可替尼乳膏(「产品」) 轻中度特应性皮炎(「AD」)的新药上市许可申请(NDA)。 ...

智通财经APP讯，康哲药业(00867)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2月24日获得中国国家 药品监督管理局(NMPA)受理磷酸芦可替尼乳膏("产品")轻中度特应性皮炎("AD")的新药上市许可申请 (NDA)。产品拟用于其他外用药控制不佳或不建议使用时，非免疫功能受损的2岁及以上儿童和成人轻 中度特应性皮炎的局部短期和非持续性慢性治疗。且该项NDA因"符合儿童生理特征的儿童用药品新品 种、剂型和规格"，已获得NMPA药品审评中心批准纳入优先审评品种名单，有望加快产品AD适应症上 市审评进程。 此外，磷酸芦可替尼乳膏已于2026年1月获得NMPA批准上市，成为中国批准的首款且唯一用于白癜风 治疗的靶向药。此次增加AD适应症NDA获受理，是产品向多治疗领域拓展的关键里程碑。 ...

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） 磷酸蘆可替尼乳膏已在輕中度AD的一項隨機、雙盲、安慰劑對照中國三期藥物臨床研 究成功達到主要終點，即使用產品治療8周，達到研究者整體評估（IGA）評分為0或1 分，且較基線改善≥2分的受試者比例，顯著高於安慰劑（63.0% vs 9.2%，P<0.001）。 關鍵次要終點，磷酸蘆可替尼乳膏治療8周達到濕疹面積及嚴重程度指數評分較基線至 少改善75%（EASI 75）的受試者比例亦顯著優於安慰劑（78.0% vs 15.4%，P<0.001）。 安全性方面，治療期出現的不良事件（TEAE）的嚴重程度大多數為輕度或中度，未發 生導致研究藥物用藥終止的TEAE，整體安全耐受性良好。 （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏增加 ...

智通财经APP讯，康哲药业(00867)发布公告，于2026年2月12日，本集团通过本公司附属公司与Teikoku Pharma USA, Inc.(TPU, 为日本Teikoku Seiyaku Co., Ltd(TSC，帝国制药)的附属公司，以下合称合作方) 就Lidoderm利多卡因凝胶贴膏(产品)签订独家经销协议(协议)。 （原标题：康哲药业(00867)：签订原研药Lidoderm®利多卡因凝胶贴膏独家经销协议） TPU是日本TSC的子公司，在疼痛管理、中枢神经系统疾病和皮肤病学等多个治疗领域开发创新产品。 TSC历史悠久，可追溯至1848年由赤泽家族创立的公司，总部位于日本香川县，并在东京和大坂设有办 事处。TSC的能力涵盖研发、临床、监管、制造和商业。 TSC率先研发出经皮给药的药物，作为全球最 大的水凝胶贴剂制造商和药物递送公司之一，TSC目前生产超过200种处方药和非处方药产品，产品销 往50多个国家。TSC还生产口服和其他外用制剂，其治疗重点是疼痛管理和皮肤病学。 本集团持续深化差异化产品布局。疼痛管理及带状疱疹后遗神经痛专科治疗市场需求显著，而现有口服 药物在局部靶向性与长期用药安全性方 ...

Group 1 - 康哲药业 has signed an exclusive distribution agreement with Teikoku Pharma USA, Inc. for the Lidoderm product, granting the company exclusive rights in mainland China for ten years starting from the first commercial sale [1] - Lidoderm is a lidocaine patch approved by the FDA in 1999 for treating postherpetic neuralgia (PHN), with clinical studies showing about 25% to 33% of patients experiencing at least 50% pain relief within 4 to 12 weeks [2] - The prevalence of PHN is significant, with estimates suggesting that approximately 4 million patients in China may be affected, particularly among older populations [3] Group 2 - Teikoku Pharma USA, Inc. is a subsidiary of Teikoku Seiyaku Co., Ltd., which has a long history in developing innovative products for pain management and other therapeutic areas [4] - The introduction of Lidoderm enhances 康哲药业's product portfolio and is expected to synergize with existing products, expanding market reach and driving growth [5] - The company aims to leverage new retail and multi-channel marketing strategies to create a comprehensive commercial ecosystem, enhancing both hospital and outpatient market penetration [5]

Group 1 - The company signed an exclusive distribution agreement for Lidoderm® with Teikoku Pharma USA, Inc., granting exclusive rights in mainland China for ten years starting from the first commercial sale [1] - Lidoderm® is a lidocaine patch approved by the FDA in 1999 for treating postherpetic neuralgia (PHN), with clinical studies showing about 25% to 33% of patients experiencing at least 50% pain relief within 4 to 12 weeks [2] - The product is recognized in clinical guidelines for its effectiveness and safety in treating PHN and other neuropathic pain conditions, such as diabetic peripheral neuropathic pain [2][3] Group 2 - PHN is defined as pain persisting for one month or more after the healing of herpes zoster rash, with a significant prevalence among older adults, particularly those aged 60 and above [3] - The company aims to enhance its product portfolio with Lidoderm®, leveraging its brand advantages and existing marketing channels to create synergies and expand into new retail models [5] - The collaboration is expected to positively impact the company's operational performance and align with the interests of its shareholders [5] Group 3 - Teikoku Pharma USA, Inc. is a subsidiary of Teikoku Seiyaku Co., Ltd., which has a long history in developing innovative products in pain management and dermatology, producing over 200 prescription and over-the-counter products [4] - The demand for pain management solutions, particularly for PHN, is significant, and topical patches are well-recognized in the Chinese market for their direct and convenient application [4]

Core Viewpoint - Kangzheng Pharmaceutical (00867.HK) has signed an exclusive distribution agreement for Lidoderm® with Teikoku PharmaUSA, Inc., granting the company exclusive rights in the target region of mainland China for a period of ten years, with potential for renewal [1] Group 1: Agreement Details - The agreement is established between Kangzheng Pharmaceutical and Teikoku PharmaUSA, Inc., a subsidiary of Teikoku Seiyaku Co., Ltd [1] - The product involved in the agreement is Lidoderm® (lidocaine transdermal system) [1] - The cooperation period begins from the first commercial sale of the product in the target region and lasts for ten years, with options for renewal as per the agreement [1] Group 2: Responsibilities - Kangzheng Pharmaceutical will hold exclusive distribution rights in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - Teikoku PharmaUSA, Inc. is responsible for the production and supply of the product [1]

自願性及業務進展公告 簽訂原研藥Lidoderm®利多卡因凝膠貼膏獨家經銷協議 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（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，於二零二六年二月十二日，本集團通過本公司附屬公司與 Teikoku Pharma USA, Inc.（「TPU」, 為日本 Teikoku Seiyaku Co., Ltd（「TSC」，帝國製藥）之附屬公 司，以下合稱「合作方」）就 Lidoderm®利多卡因凝膠貼膏（「產品」）簽訂獨家經銷 協議（「協議」）。 根據協議，本集團獲得該產品在中華人民共和國（就本協議而言，不含香港特別行政區、 澳門特別行政區及臺灣地區，以下簡稱（「目標區域」）內的獨家經銷權利，合作方負 責該產品的生產及供應相關事宜。本協議合作期限首期自該產品在目標區域內首次商業 銷售之日起計十年，到期後根據協議約定續期。 Lidoder ...

Core Viewpoint - The report from Guolian Minsheng Securities highlights the synergistic effects of small nucleic acid drugs and GLP-1 class drugs in the weight loss sector, suggesting they could become a "golden duo" for weight management [1][4]. Group 1: Drug Efficacy and Development - Arrowhead has reported promising initial weight loss results from two small nucleic acid drugs targeting INHBE and ALK7, with ARO-INHBE showing an average fat reduction of 9.9% and liver fat reduction of up to 38.6%, alongside a 3.6% increase in lean tissue [1]. - ARO-ALK7 demonstrated a dose-dependent average reduction of ALK7 mRNA by 88%, confirming the TRiM platform's ability to inhibit fat cell gene expression [1]. - Wave Life's WVE-007 targeting liver INHBE showed a 9.4% reduction in visceral fat and a 4.5% overall fat reduction after three months, with a 3.2% increase in lean body mass [3]. Group 2: Market Trends and Collaborations - Major pharmaceutical companies are increasingly investing in small nucleic acid drugs, with Eli Lilly committing $1.2 billion in collaboration with Saint Inbiotech for RNAi candidate drug development for metabolic diseases [3]. - Eli Lilly also invested $1 billion in HAYA's lncRNA platform for obesity and related metabolic disease treatments, while Novo Nordisk partnered with Replicate Bioscience for a $550 million project targeting obesity and type 2 diabetes [3]. - The speed of Chinese pharmaceutical companies in developing small nucleic acid drugs for weight loss is nearly on par with international counterparts, with several companies like Hengrui Medicine and Innovent Biologics actively pursuing this area [5]. Group 3: Investment Recommendations - The report suggests focusing on companies involved in small nucleic acid weight loss targets, including Hengrui Medicine, Chengdu Xian Dao, China National Pharmaceutical Group, East China Pharmaceutical, and others [6].

根据合作协议，双方将结合英矽智能已验证的AI平台与AI赋能创新药研发能力，以及康哲药业经验丰 富的研发团队和对疾病领域的深度认知，共同推进不少于2个研发项目的合作开发。同时，英矽智能有 望就每个项目获得最高达数千万港元的研发费用支持。此次合作将充分发挥双方在药物研发、临床开发 及商业化全周期的协同优势，通过资源整合与技术互补，加速高潜力创新药物的研发与转化。英矽智能 将依托其Pharma.AI平台以及在靶点发现、小分子设计与优化等领域的技术能力，推动候选分子的高效 筛选与验证；康哲药业则凭借其在临床开发策略制定、注册申报路径规划、临床试验组织实施以及商业 化推广方面的丰富经验和成熟网络，推动项目从临床前过渡至临床及上市阶段。 近日，英矽智能发布公告称，与康哲药业控股有限公司在中枢神经系统及自身免疫疾病领域的多个项目 上达成一系列由AI赋能的创新药物研发合作。 ...