Core Viewpoint - 康哲药业's subsidiary 德镁医药 has achieved positive results in a Phase III clinical trial for its product,芦可替尼乳膏, targeting mild to moderate atopic dermatitis (AD) in China, and is moving forward with its new drug application (NDA) process [1][2]. Group 1: Clinical Trial Results - The Phase III trial involved 192 patients and was a randomized, double-blind, placebo-controlled, multi-center study conducted in China [1]. - The primary endpoint was met, with 63.0% of patients treated with芦可替尼乳膏 achieving an Investigator's Global Assessment (IGA) score of 0 or 1, and a ≥2 point improvement from baseline, significantly higher than the 9.2% in the placebo group (P<0.001) [2]. - A key secondary endpoint showed that 78.0% of patients treated with芦可替尼乳膏 achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI 75) score, compared to 15.4% in the placebo group (P<0.001) [2]. Group 2: Safety and Tolerability - The majority of treatment-emergent adverse events (TEAEs) during the trial were mild to moderate, with no serious adverse events leading to discontinuation of the study drug [2]. - Overall, the safety and tolerability of芦可替尼乳膏 were deemed good [2]. Group 3: Regulatory Progress - The company is actively advancing the new drug application (NDA) process for芦可替尼乳膏 in China [2].
康哲药业(00867)：创新药磷酸芦可替尼乳膏AD适应症中国三期药物临床研究取得积极结果