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]
康哲药业(00867)：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