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]
康哲药业：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