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。 自願性及業務進展公告 獲得1類新藥MG-K10人源化單抗注射液新增 慢性阻塞性肺疾病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，本集團擁有共同開發權（除特應性皮炎（AD）外）及獨家商業化權利的1類 新藥抗IL-4Rα MG-K10人源化單抗注射液（「MG-K10」或「產品」）於二零二五年九 月二十九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， NMPA同意開展MG-K10用於慢性阻塞性肺疾病（COPD）的臨床試驗。 MG-K10 MG-K10是一種創新的長效抗IL-4Rα人源化單抗，能同時阻斷關鍵2型炎症因子IL-4和 IL-13的信號傳導，用於治療2型炎症性疾病。目前已上市的抗IL-4Rα藥物均需要每2週給 藥一次，而MG-K10具有更長的半衰期，可實現4週一次的給藥 ...

FF301 截至月份: 2025年9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9月30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 | | 100,000,000 | 本月底法定/註冊股 ...

Core Viewpoint - 康哲药业's subsidiary 德镁医药 is applying for an independent listing on the Hong Kong Stock Exchange, focusing on the innovative drug MG-K10, which has received approval for clinical trials in China for chronic spontaneous urticaria [1][2] Group 1: Product Development - MG-K10 is a long-acting humanized monoclonal antibody targeting IL-4Rα, designed to treat type 2 inflammatory diseases, with a dosing frequency of once every four weeks, potentially becoming the first long-acting IL-4Rα monoclonal antibody on the market [1] - The drug has shown positive results in a Phase III clinical trial for moderate to severe atopic dermatitis (AD), meeting the primary endpoint of the study [2] - MG-K10 is also in Phase III clinical trials for asthma, nodular prurigo, and seasonal allergic rhinitis, with previous Phase II trials demonstrating good efficacy and safety in adults with moderate to severe asthma [2] Group 2: Regulatory Approvals - The National Medical Products Administration (NMPA) has granted approval for clinical trials of MG-K10 for chronic eosinophilic esophagitis and chronic sinusitis with nasal polyps [2]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 is seeking independent listing on the Hong Kong Stock Exchange and has received approval for clinical trials of its innovative drug MG-K10, which targets chronic spontaneous urticaria and has the potential to be a best-in-class treatment for type 2 inflammatory diseases [1][2] Group 1 - 德镁医药 has been granted a clinical trial approval by the NMPA for MG-K10 to conduct a Phase III trial for chronic spontaneous urticaria, with the trial set to begin on September 28, 2025 [1] - MG-K10 is a long-acting humanized monoclonal antibody that blocks IL-4 and IL-13 signaling, allowing for a dosing frequency of once every four weeks, compared to existing treatments that require biweekly administration [1] - The drug has shown positive results in a Phase III clinical study for moderate to severe atopic dermatitis, achieving the primary endpoint of the trial [2] Group 2 - MG-K10 is also in Phase III clinical trials for asthma, nodular prurigo, and seasonal allergic rhinitis, with previous Phase II trials demonstrating good efficacy and safety in moderate asthma patients [2] - Additional indications for MG-K10, including eosinophilic esophagitis and chronic sinusitis with nasal polyps, have also received NMPA approval for clinical trials [2]

Core Viewpoint - Kangzheng Pharmaceutical (00867) announced that its subsidiary, Demy Pharmaceutical, is applying for an independent listing on the Hong Kong Stock Exchange and has received approval from the NMPA for clinical trials of its innovative drug MG-K10, which targets chronic spontaneous urticaria (CSU) [1][2] Group 1 - MG-K10 is a long-acting humanized monoclonal antibody that blocks IL-4 and IL-13 signaling, potentially becoming the first long-acting IL-4Rα monoclonal antibody on the market with a dosing frequency of once every four weeks [1] - The drug has shown positive results in a Phase III clinical trial for moderate to severe atopic dermatitis (AD), meeting the primary endpoint of the study [2] - MG-K10 is also in Phase III trials for asthma, nodular prurigo, and seasonal allergic rhinitis, with previous Phase II trials demonstrating good efficacy and safety in moderate asthma patients [2] Group 2 - The drug has received NMPA approval for clinical trials in eosinophilic esophagitis and chronic sinusitis with nasal polyps [2]

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。 自願性及業務進展公告 1類新藥MG-K10人源化單抗注射液新增獲得 慢性自發性蕁麻疹適應症藥物III期臨床試驗批准通知書 1 慢性自發性蕁麻疹(CSU) CSU是一種常見的慢性炎症性皮膚疾病，其特徵是蕁麻疹（風團）及/或血管水腫（腫脹） 反覆病發持續六週或更長時間，且並無可識別的外部誘因。根據灼識諮詢報告，中國CSU 患者於2023年达約10.2百萬人。CSU的病情特徵使其可能會對患者的生活質量造成重大 影響，且由於CSU的病因不明，其治療仍然具有挑戰性。抗組胺藥是CSU的標準治療方 案。然而，許多患者在接受抗組胺藥治療後疾病仍然得不到有效控制，而替代治療選擇 也有限。IL-4Rα單抗已經驗證了對CSU治療的有效性，且整體安全性良好，為CSU的治 療提供了新的選擇，尤其是對於那些對傳統治療反應不佳或無法耐受的患者，但目前尚 未有針對CSU治療的IL-4Rα單抗相關產品在中國獲批上市。 MG-K10具有成為同類 ...

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 ...