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)连同其附属公司取得磷酸芦可替尼乳膏(芦可替尼乳膏) 轻中度特应性皮炎(AD)的中国三期药物临床研究积极结果。 产品用于轻中度特应性皮炎的中国三期临床研究成功达到主要终点，即使用芦可替尼乳膏治疗8周，达 到研究者整体评估(IGA)评分为0或1分，且较基线改善≥2分的受试者比例，显著高于安慰剂 (63.0%vs9.2%，P<0.001)。关键次要终点，芦可替尼乳膏治疗8周达到湿疹面积及严重程度指数评分较 基线至少改善75%(EASI75)的受试者比例亦显著优于安慰剂(78.0%vs15.4%，P<0.001)。安全性方面，治 疗期出现的不良事件(TEAE)的严重程度大多数为轻度或中度，未发生导致研究药物用药终止的治疗期 出现的不良事件(TEAE)，整体安全耐受性良好。 此外，集团正积极推进产品在中国的新药上市申请(NDA)工作。 该试验是一项在中国人群开展的随机、双盲、安慰剂对照、多中心的临床研究，共入组192例患者，旨 在评估产品治疗轻中度AD的安全性和有效性。该研究组 ...

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]

与GnRH受体激动剂相比，GnRH受体拮抗剂无"点火效应"，可以快速竞争性结合GnRH受体并阻断其启 动，快速抑制FSH和LH的释放，进而抑制下游雌激素的分泌，缓解子宫肌瘤的进展，在较低的剂量下 可实现部分抑制，在更高的剂量下则达到完全抑制。此外，由于拮抗剂的作用可逆，在停药一段时间 后，当内源性GnRH重新结合受体时，患者的性腺功能有望恢复正常。CMS-D002作为一款口服非肽类 小分子GnRH受体拮抗剂，结合其优异的临床前表现，有望为患者提供更优的治疗选择。 CMS-D002将进一步丰富集团产品矩阵，为中国患者提供差异化用药选择，满足兼具良好疗效、安全性 与良好患者依从性药物的临床需求，使患者受益。CMS-D002将有效增强集团在妇科治疗领域的实力， 依托现有专家网络与市场资源，提升该领域的竞争力与市场地位。 集团正积极准备开展相关临床试验工作，力争该产品尽快上市。 康哲药业(00867)发布公告，集团自主研发的创新药CMS-D002胶囊(CMS-D002)于2025年9月25日获得中 国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，于9月26日收到药物临床试验批准通知 书。NMPA同意开展 ...

与GnRH受体激动剂相比，GnRH受体拮抗剂无"点火效应"，可以快速竞争性结合GnRH 受体并阻断其启 动，快速抑制FSH和LH的释放，进而抑制下游雌激素的分泌，缓解子宫肌瘤的进展，在较低的剂量下 可实现部分抑制，在更高的剂量下则达到完全抑制。此外，由于拮抗剂的作用可逆，在停药一段时间 后，当内源性GnRH重新结合受体时，患者的性腺功能有望恢复正常。CMS-D002作为一款口服非肽类 小分子GnRH受体拮抗剂，结合其优异的临床前表现，有望为患者提供更优的治疗选择。 CMS-D002将进一步丰富集团产品矩阵，为中国患者提供差异化用药选择，满足兼具良好疗效、安全性 与良好患者依从性药物的临床需求，使患者受益。CMS-D002将有效增强集团在妇科治疗领域的实力， 依托现有专家网络与市场资源，提升该领域的竞争力与市场地位。 集团正积极准备开展相关临床试验工作，力争该产品尽快上市。 智通财经APP讯，康哲药业(00867)发布公告，集团自主研发的创新药CMS-D002胶囊(CMS-D002)于2025 年9月25日获得中国国家药品监督管理局(NMPA)签发的药物临床试验批准通知书，于9月26日收到药物 临床试验批准通知 ...

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].

CMS-D002是小分子促性腺激素释放激素(GnRH)受体拮抗剂。GnRH是由下丘脑神经内分泌细胞合成的 十肽激素，是调控生殖系统激素释放的重要因子。CMS-D002与内源性GnRH竞争性结合垂体上的GnRH 受体，在中枢神经水平阻断垂体性腺轴，减少内源性促卵泡刺激素(FSH)和促黄体生成素(LH)的释放， 从而抑制下游雌激素、黄体酮和睾酮的分泌，缓解性激素相关疾病的进展。CMS-D002在临床前研究中 表现出优异的有效性和安全性。此前，CMS-D002已于2024年2月6日，获得NMPA签发的药物临床试验 批准通知书，集团正在稳步推进子宫内膜异位症的I期临床研究。近日，CMS-D002再次获得NMPA批准 临床试验，适应症范围新增子宫肌瘤适应症。除子宫内膜异位症及子宫肌瘤外，CMS-D002未来可开发 用于治疗前列腺癌等疾病。 CMS-D002将进一步丰富集团产品矩阵，为中国患者提供差异化用药选择，满足兼具良好疗效、安全性 与良好患者依从性药物的临床需求，使患者受益。CMS-D002将有效增强本集团在妇科治疗领域的实 力，依托现有专家网络与市场资源，提升该领域的竞争力与市场地位。 格隆汇9月26日丨康哲药业 ...

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） 自願性及業務進展公告 創新藥磷酸蘆可替尼乳膏AD適應症中國三期藥物臨床研究取得積極結果 有關AD AD是一種慢性、復發性、炎症性的皮膚疾病，臨床主要表現為皮膚乾燥、慢性濕疹樣皮 損和明顯瘙癢，可能嚴重影響患者的生活品質。據估算，2024年中國特應性皮炎患者超 過5,400萬人，基於SCORAD評分，輕度、中度、重度特應性皮炎的占比分別為73%、25% 和2%。外用藥物是AD最基本的治療方法。傳統外用藥物如外用糖皮質激素（TCS）及外 用鈣調神經磷酸酶抑制劑（TCIs）有長期用藥的不良反應或療效有限的臨床痛點，臨床 亟需新的治療選擇。 China Medical System Holdings Limited（「本公司」，連同 ...

CMS-D002是小分子促性腺激素釋放激素（GnRH）受體拮抗劑。GnRH是由下丘腦神經 內分泌細胞合成的十肽激素，是調控生殖系統激素釋放的重要因子。CMS-D002與內源 性GnRH競爭性結合垂體上的GnRH受體，在中樞神經水平阻斷垂體性腺軸，減少內源性 促卵泡刺激素（FSH）和促黃體生成素（LH）的釋放，從而抑制下遊雌激素、黃體酮和 睾酮的分泌，緩解性激素相關疾病的進展。CMS-D002在臨床前研究中表現出優異的有 效性和安全性。此前，CMS-D002已於二零二四年二月六日，獲得NMPA簽發的藥物臨 床試驗批准通知書，本集團正在穩步推進子宮內膜異位症的I期臨床研究。近日， CMS-D002再次獲得NMPA批准臨床試驗，適應症範圍新增子宮肌瘤適應症。除子宮內 膜異位症及子宮肌瘤外，CMS-D002未來可開發用於治療前列腺癌等疾病。 子宮肌瘤（Uterine fibroids, UFs）由子宮平滑肌組織增生而形成，是女性最常見的一種 良性腫瘤，其病因尚不明確，可能與遺傳易感性和性激素水準有關，高危因素包括年齡、 種族、肥胖和飲食等。UFs發病年齡在15至59歲之間，以30至44歲的女性最為常見，發 病率整體呈 ...

Core Insights - Kangzheng Pharmaceutical has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. to obtain exclusive commercialization rights for two Class 1 therapeutic biological products in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1][2] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a passive immunization agent for tetanus that offers rapid and long-lasting protection, outperforming human tetanus immunoglobulin (HTIG). The product has met its primary efficacy endpoint in Phase III clinical trials and is included in the NMPA's list of breakthrough therapeutic varieties as of May 2024, with its New Drug Application (NDA) accepted in May 2025, potentially becoming China's second approved passive immunization monoclonal antibody for tetanus [1] - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human dual-specific antibody targeting rabies virus glycoprotein epitopes I and/or III. It aligns with WHO recommendations for developing "cocktail" therapies targeting different antigen sites, allowing for large-scale standardized production. Its NDA for passive immunization in adults exposed to suspected rabies virus was accepted by CDE on January 14, 2025, and clinical trial applications for children aged 2 to 18 have been approved, with Phase III trials currently underway [2] Group 2: Market Potential and Strategic Positioning - The passive immunization market for tetanus and rabies is vast, with existing passive immunization agents facing limitations in safety and accessibility. The approval and market entry of Weikangduta and Sileweimi monoclonal antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, enhancing the synergy with Kangzheng Pharmaceutical's existing products in expert networks and market resources [2]

Core Insights - Kangzheng Pharmaceutical Holdings Limited has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. for two innovative biological agents aimed at infectious disease prevention, obtaining exclusive commercialization rights in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a recombinant humanized monoclonal antibody that provides rapid and long-lasting protection against tetanus, outperforming human tetanus immunoglobulin (HTIG) [2] - The product targets the C-terminal heavy chain of tetanus toxin (TeNT-Hc), blocking its entry into neuronal cells, and has achieved primary efficacy endpoints in Phase III clinical trials [2] - The NDA for Weikangduta Monoclonal Antibody was accepted by the National Medical Products Administration (NMPA) on May 22, 2025, and it was included in the list of breakthrough therapies by the NMPA in May 2024 [2] Group 2: Market Potential - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human bispecific antibody for passive immunity against rabies, designed to block the rabies virus from infecting neurons before the rabies vaccine can take effect [3] - The product can be produced in a standardized and stable manner, with broad neutralization spectrum, low immunogenicity, minimal interference with vaccine-induced immunity, and controllable costs [3] - The NDA for Sileweimi Monoclonal Antibody for adults was accepted by the NMPA on January 14, 2025, and clinical trial applications for children aged 2 to 18 were approved in July 2025, with ongoing Phase III clinical trials [3] Group 3: Strategic Focus - Kangzheng Pharmaceutical is committed to developing innovative products with clinical value and differentiated advantages, addressing the limitations of existing passive immunization agents in terms of safety and accessibility [3] - The approval and market launch of Weikangduta and Sileweimi Monoclonal Antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, leveraging the company's existing market resources and expert networks [3]