Core Viewpoint - The company, Akeso Inc. (09939), experienced a stock price increase of over 3% during trading, closing at HKD 2.16 with a trading volume of HKD 8.0645 million, following the announcement of positive results from its Phase II clinical trial for the acne treatment compound GT20029 [1]. Group 1: Clinical Trial Results - The Phase II clinical trial for GT20029, a novel targeted androgen receptor (AR) protein degradation compound, successfully met its primary endpoint with statistically significant and clinically meaningful results [1]. - The efficacy, safety, and pharmacokinetic characteristics of GT20029 were reported to be excellent, with a recommended dosage for the Phase III clinical trial set at 0.5% [1]. - The trial was a multicenter, randomized, double-blind, placebo-controlled study conducted at 10 centers nationwide, led by Professor Xiang Leihong from Huashan Hospital affiliated with Fudan University [1].

Core Viewpoint - The company, 开拓药业-B, has seen a stock price increase of over 3% during trading, currently at 2.16 HKD, following the announcement of successful Phase II clinical trial results for its PROTAC compound GT20029 in treating acne [1] Company Summary - 开拓药业-B announced on August 12 that its self-developed PROTAC compound GT20029 has successfully met the primary endpoint in a Phase II clinical trial for acne treatment, showing statistical significance and clinical relevance [1] - The trial demonstrated excellent efficacy, safety, and pharmacokinetic characteristics, with a recommended dosage for the upcoming Phase III trial set at 0.5% [1] - The Phase II trial was a multicenter, randomized, double-blind, placebo-controlled study conducted at 10 centers nationwide, led by Professor 项蕾红 from Huashan Hospital affiliated with Fudan University [1] Industry Summary - The successful results of the Phase II clinical trial for GT20029 may indicate a positive trend in the dermatological treatment market, particularly for acne, which could attract further investment and interest in similar therapeutic developments [1]

Core Viewpoint - The stock of Akeso Inc. (09939) rose over 3% during trading, following the announcement of successful Phase II clinical trial results for its acne treatment GT20029, which met its primary endpoint with statistical significance and clinical relevance [1] Group 1: Clinical Trial Results - The Phase II clinical trial for GT20029, a novel androgen receptor-targeted PROTAC compound, successfully achieved its primary endpoint, demonstrating efficacy, safety, and pharmacokinetic characteristics [1] - The recommended dosage for the upcoming Phase III clinical trial has been established at 0.5% [1] - The trial was a multicenter, randomized, double-blind, placebo-controlled study conducted at 10 centers across the country, led by Professor Xiang Leihong from Huashan Hospital affiliated with Fudan University [1] Group 2: Market Reaction - Following the announcement, Akeso's stock price increased by 2.86%, reaching HKD 2.16, with a trading volume of HKD 8.0645 million [1]

Core Viewpoint - The company has successfully completed a Phase II clinical trial for its self-developed PROTAC compound GT20029, targeting androgen receptors for acne treatment, achieving statistically significant and clinically meaningful results [1][2] Efficacy - The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled study, evaluating the efficacy, safety, and pharmacokinetics of GT20029 at doses of 0.5% and 1.0% administered once daily [1] - In terms of efficacy, the total lesion count (excluding nodules) showed P-values of 0.01 for the 0.5% group and 0.05 for the 1.0% group compared to the placebo [1] - For inflammatory lesion count changes from baseline, both the 0.5% and 1.0% groups had P-values less than 0.01 compared to the placebo [1] Treatment Success Rate - The treatment success rate, defined by the Investigator's Global Assessment (IGA) score dropping to 0-1 with a decrease of at least 2 levels, showed P-values of 0.03 for the 0.5% group and 0.15 for the 1.0% group compared to the placebo [2] Safety - GT20029 gel demonstrated satisfactory safety and tolerability in the clinical trial, with a low overall incidence of adverse events [2] - The incidence of drug-related adverse events was comparable between the 0.5% and 1.0% groups, both being lower than that of the placebo group, with all events classified as mild [2]

Core Viewpoint - The company has successfully achieved the primary endpoint in the Phase II clinical trial of its self-developed PROTAC compound GT20029 for the treatment of acne, demonstrating statistical significance and clinical relevance in efficacy, safety, and pharmacokinetic characteristics [1][2]. Efficacy - The Phase II clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, evaluating GT20029 at doses of 0.5% and 1.0% once daily (QD) [1]. - In terms of total lesion count (excluding nodules), the P-values for the 0.5% QD and 1.0% QD groups compared to the placebo were 0.01 and 0.05, respectively [1]. - For non-inflammatory lesion count percentage change from baseline, the P-values were 0.14 for the 0.5% QD group and 0.09 for the 1.0% QD group; for inflammatory lesion count percentage change, both groups had P-values less than 0.01 compared to placebo [1]. Treatment Success Rate - The treatment success rate, defined by the Investigator's Global Assessment (IGA) score dropping to 0-1 with a decrease of at least 2 levels, showed P-values of 0.03 for the 0.5% QD group and 0.15 for the 1.0% QD group compared to placebo [2]. Safety - GT20029 gel demonstrated satisfactory safety and tolerability in the clinical trial, with a low overall incidence of adverse events [2]. - The incidence of drug-related adverse events was comparable between the 0.5% QD and 1.0% QD groups, both of which were lower than the placebo group, with all adverse events being of mild severity [2].