Core Insights - Novartis is considering selling its ophthalmology business to China-based Kanghong Pharmaceutical, reflecting a strategic shift in response to changing global market dynamics [1][2] - The company has historically held a dominant position in the Chinese ophthalmology market but is now focusing on core areas such as cardiovascular, renal, metabolic, and oncology [1] - The competitive landscape in the Chinese ophthalmology market is intensifying, with Kanghong Pharmaceutical increasing its market share through innovative drugs and strong commercialization channels [1][2] Company Strategy - Novartis has been restructuring its global operations, including divesting from its ophthalmology segment to concentrate on four key therapeutic areas [1] - The sale of mature ophthalmic products in China is part of Novartis's strategy to reallocate resources towards more promising business segments [1] Market Dynamics - The emergence of new drugs like Faricimab is eroding Novartis's market share, leading to declining sales in its retinal disease portfolio [2] - The rise of biosimilars is expected to further complicate the competitive landscape by driving down prices in the ophthalmology sector [2] Competitive Landscape - Kanghong Pharmaceutical's acquisition of Novartis's ophthalmology business could reshape the market, leveraging its extensive distribution channels against Kanghong's research and development capabilities [2] - The evolving competition between Kanghong's broad distribution and Kanghong Pharmaceutical's innovative research will be a focal point in the future of the ophthalmology market [2] Investment Opportunities - Investors are advised to monitor Novartis's strategic adjustments and their implications for the market, as well as the performance of local companies in innovation and market expansion [2] - The ophthalmology drug market is expected to remain challenging yet full of opportunities for investment [2]

Core Viewpoint - Kangzheng Pharmaceutical (00867) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its new drug MG-K10, a humanized monoclonal antibody targeting IL-4Rα, for chronic obstructive pulmonary disease (COPD) [1] Group 1 - The drug MG-K10 has been granted a clinical trial approval notice by NMPA, allowing the company to proceed with trials for COPD [1] - The company holds co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for MG-K10 [1]

Core Viewpoint - Kangzheng Pharmaceutical has received approval from the NMPA for clinical trials of its innovative long-acting anti-IL-4Rα monoclonal antibody MG-K10, which has the potential to become a best-in-class treatment for type 2 inflammatory diseases, including COPD [1][2] Group 1 - The NMPA granted a clinical trial approval for MG-K10 on September 29, 2025, allowing the company to conduct trials for chronic obstructive pulmonary disease (COPD) [1] - MG-K10 is designed to block key type 2 inflammatory factors IL-4 and IL-13, with a longer half-life allowing for administration every four weeks, compared to existing treatments that require biweekly dosing [1] - The product has shown positive results in a Phase III clinical study for moderate to severe atopic dermatitis (AD), meeting 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 adults with moderate to severe asthma [2] - Additional indications for MG-K10, including chronic spontaneous urticaria, eosinophilic esophagitis, and chronic sinusitis with nasal polyps, have also received NMPA approval for clinical trials [2]

Core Viewpoint - Kangzheng Pharmaceutical (00867) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its new drug MG-K10, a humanized monoclonal antibody targeting IL-4Rα, for the treatment of chronic obstructive pulmonary disease (COPD) [1] Group 1 - The company holds co-development rights (excluding atopic dermatitis) and exclusive commercialization rights for the new drug MG-K10 [1] - The NMPA issued the drug clinical trial approval notice on September 29, 2025 [1] - The clinical trial will focus on the application of MG-K10 in treating COPD [1]

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 ...