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].
康哲药业(00867.HK)：长效抗IL-4Rα人源化单抗注射液特应性皮炎适应症中国上市许可申请已获受理