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]
康哲药业(00867.HK)：获得1类新药MG-K10人源化单抗注射液新增慢性阻塞性肺疾病适应症药物临床试验批准通知书