Core Viewpoint - 康哲药业's subsidiary 德镁医药 is applying for an independent listing on the Hong Kong Stock Exchange and has received acceptance for its new drug application for MG-K10, an innovative long-acting anti-IL-4Rα monoclonal antibody, which is intended for the treatment of moderate to severe atopic dermatitis in adults [1][2]. Group 1: Product Development and Clinical Trials - MG-K10 is designed to block key type 2 inflammatory factors IL-4 and IL-13 signaling pathways and has shown positive results in a Phase III clinical trial for adult moderate to severe atopic dermatitis, achieving primary endpoints [2]. - In the clinical trial, 76.6% of participants achieved an Investigator's Global Assessment (IGA) score of 0 or 1, with at least a 2-point improvement from baseline, while 94.3% achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75) [2]. - The drug has a longer half-life allowing for administration every four weeks, compared to existing anti-IL-4Rα drugs that require biweekly dosing, positioning MG-K10 as a potential Best-in-Class treatment [2]. Group 2: Future Potential and Indications - MG-K10 has potential applications for other type 2 inflammatory diseases, including asthma, nodular prurigo, seasonal allergic rhinitis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, chronic sinusitis with nasal polyps, and eosinophilic esophagitis [3]. - Clinical trials for asthma, nodular prurigo, and seasonal allergic rhinitis have already entered Phase III in China [3].

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]

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 ...

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]

Core Viewpoint - Hunan Maijiz Biological Technology Co., Ltd. has submitted an application for an IPO on the Hong Kong Stock Exchange, with CICC as the sole sponsor [1] Company Overview - Maijiz Biological was established in 2016 and is a clinical-stage biopharmaceutical company focused on unmet medical needs in allergic diseases, autoimmune diseases, and other inflammatory and immune diseases [3] - The company currently has no products on the market, with its core product MG-K10 being a long-acting anti-IL-4Rα antibody, which is considered to have "best-in-class" potential [3] Financial Performance - The company has reported continuous losses, with a total adjusted net loss of approximately 307 million yuan over the past two years [5] - Revenue for the first three months of 2023, 2024, and 2025 was 872,200 yuan, 24,000 yuan, and 0 yuan respectively, with corresponding net losses of 253 million yuan, 178 million yuan, and 27.3 million yuan [4] Product Pipeline - In addition to MG-K10, Maijiz Biological has two other self-developed pipelines that have entered clinical stages: MG-014 targeting TSLP for asthma and COPD, and MG-013 targeting MASP-2 for rare and inflammatory diseases [4] - The company has several other preclinical candidates, including MG-012, MG-015, MG-018, MG-208, and MG-242, which are in development [4] Valuation and Funding - The company has undergone multiple rounds of financing, raising over 700 million yuan, with a post-money valuation growth of nearly 45 times over eight years [7] - The valuation increased from 58 million yuan in early 2017 to 2.64 billion yuan in May 2025 [10] Shareholding Structure - The controlling shareholder, Zhang Chenghai, holds approximately 42.65% of the company, while other significant shareholders include Kangzhe Pharmaceutical and Hunan Guochuang [10] Use of IPO Proceeds - The funds raised from the IPO will be used for ongoing and planned clinical trials of the core product MG-K10, as well as for MG-014, MG-013, and other preclinical and discovery-stage assets [10]

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 就1類新藥MG-K10人源化單抗注射液簽訂合作協議 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，於二零二五年一月二十四日，本集團通過本公司附屬公司與湖南麥濟生物技 術股份有限公司（「麥濟生物」）及其附屬公司就1類新藥抗IL-4Rα人源化單抗注射液 MG-K10（「MG-K10」或「產品」）簽訂合作協議（「協議」）。 根據協議，本集團獲得產品在中國大陸、香港特別行政區、澳門特別行政區、台灣地區 及新加坡（「區域」）的協議所約定之共同開發權及獨家商業化權利；麥濟生物配合商 業化活動，並銷售、供應產品。合作期限為永久。 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，如特應性皮炎（Atopic Derma ...