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]
康哲药业(00867.HK)1类新药MG-K10人源化单抗注射液新增获得慢性自发性荨麻疹适应症药物III期临床试验批准通知书