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].

Group 1 - The core product GT20029 has successfully completed Phase II clinical trials for acne treatment, achieving primary endpoints with statistical significance and clinical relevance [1][2] - The recommended dosage for the upcoming Phase III clinical trial has been established at 0.5% [1] - The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled study conducted at 10 centers across China, led by Professor Xiang Leihong from Huashan Hospital [1] Group 2 - GT20029 is developed based on the company's proprietary PROTAC platform and is positioned as a next-generation treatment for androgenetic alopecia and acne [2] - It is the first topical PROTAC compound globally to complete Phase II clinical trials, maintaining a leading position in the market [2] - The company is planning to initiate Phase III clinical trials for GT20029 in acne treatment to further expand its first-mover advantage in the topical PROTAC field [2] Group 3 - Winlevi® (clascoterone 1%) is the first acne medication approved by the FDA in nearly 40 years with a new mechanism of action, indicating the validation of targeting androgen receptors for acne treatment [2] - Winlevi® has become the most prescribed brand topical acne medication in the U.S., with over 1.3 million prescriptions written by more than 17,900 physicians since its launch [2] - The approval of acne medications targeting AR pathways suggests a promising market for GT20029 as an innovative, safe, and effective treatment option for dermatologists and patients [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 ( 股份代號 : 9939) 自願公告 GT20029 凝膠治療痤瘡中國 I I 期臨床試驗達到主要終點 本公告由開拓藥業有限公司*（「本公司」，連同其附屬公司統稱「本集團」）自願 刊發，以知會本公司股東及潛在投資者有關本集團的最新進展。 茲提述本公司日期為 2024 年 6 月 17 日的自願公告，內容有關 GT20029 凝膠治療痤 瘡的中國 II 期臨床試驗（「該項 II 期臨床試驗」），其已於 2024 年 6 月 17 日完成首 例受試者入組。 本公司董事（「董事」）會（「董事會」）欣然宣佈，其自主研發的新型靶向雄激素 受體（「AR」）的蛋白降解嵌合體（「PROTAC」）化合物 GT20029 治療痤瘡的 該項 II 期臨床試驗讀出頂線數據。數據顯示，該項 II 期臨床試驗成功達到主要研究終 點，結果具有統計學顯著性及臨床意義，且有效性、安全性和藥代動力學特徵均表現 出色，並確定 III 期臨床 ...