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开拓药业(09939) - 完成先旧后新配售现有股份及根据一般授权认购新股份
2025-08-14 12:51
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分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 本公告或其任何副本概不得直接或間接在美國或在刊發或派發本公告屬違法的任何其他司 法權區刊發或派發。 本公告僅供參考,並不構成收購、購買或認購任何證券的邀請或要約。 本公告並不構成或組成在美國或在有關要約屬違法的任何其他司法權區購買或認購證券的 任何要約或招攬的一部分。本公告所述證券未曾亦不會根據經不時修訂1933年美國證券法(「美 國證券法」)或美國任何其他州證券法律登記,而且除非根據美國證券法登記或獲得美國證券 法登記規定的豁免或屬不受美國證券法登記規定約束的交易,否則不得在美國境內發售或出 售。本公司無意根據美國證券法登記本公告所述的任何證券或在美國公開發售證券。 開 拓 藥 業 有 限 公 司 * KINTOR PHARMACEUTICAL LIMITED ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股 份 代 號:9939) 完成先舊後新配售現有股份及 根據一般授權認購新股份 ...
港股午评|恒生指数早盘涨1.88% 恒生生物科技指数大涨3.77%
智通财经网· 2025-08-13 04:09
Group 1: Market Overview - The Hang Seng Index rose by 1.88%, gaining 470 points to close at 25,439 points, while the Hang Seng Tech Index increased by 2.35% [1] - The early trading volume in the Hong Kong stock market reached HKD 143.8 billion [1] Group 2: Biotechnology Sector - The Hang Seng Biotechnology Index surged by 3.77%, driven by a collective rise in pharmaceutical stocks following the debut of the "dual directory" for drug applications [1] - Zhonghui Biotech-B (02627) saw a significant increase of 24%, while Jiuyuan Gene (02566) rose by 8.99%, and Kintor Pharmaceutical (09939) increased by 5.7% [1] - Innovent Biologics (01801) experienced a rise of 7.27%, and He Yu-B (02256) reached a new high with a 7.38% increase, reporting a 59% year-on-year growth in net profit for the first half of the year [1] Group 3: Pharmaceutical Developments - Daqi Pharmaceutical-B (06996) rose over 15% as Claudin 18.2 ADC was proposed for inclusion as a breakthrough therapy [2] Group 4: Technology Sector - Tencent's subsidiaries reported generally better-than-expected earnings, with Tencent Music-SW (01698) rising by 15%, and Reading Group (00772) also increasing by over 15% [2] - Weimeng Group (02013) saw an increase of over 7% [2] Group 5: Industrial and Manufacturing Sector - Chongqing Machinery (02722) rose by 8.9%, with an expected 50% year-on-year growth in net profit due to rapid growth in AIDC engine demand [3] - Zhongyan Hong Kong (06055) increased by over 7%, maintaining its position in the domestic cigarette export tax-free business, with earnings to be announced next Friday [3] Group 6: Technology and Electronics - Qiu Tai Technology (01478) rose by over 8%, reporting a 167% year-on-year increase in net profit for the first half of the year, leading to target price upgrades from multiple institutions [4] - Hong Teng Precision (06088) increased by over 9% post-earnings, with a cumulative rise of over 60% in the month, reporting an 11% revenue growth but a 3% decline in net profit [5] - Minmetals Resources (01208) rose by over 9% after reporting a 15-fold increase in net profit for the first half of the year and lowering cost guidance for its mines [6] Group 7: Performance Review - 361 Degrees (01361) fell by over 10% post-earnings, with institutions stating that the first half performance met expectations, but net profit growth was slightly lower than revenue growth [7]
港股异动 开拓药业-B(09939)盘中涨超3% GT20029凝胶治疗痤疮II期临床试验达到主要终点
Jin Rong Jie· 2025-08-13 03:57
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].
开拓药业-B盘中涨超3% GT20029凝胶治疗痤疮II期临床试验达到主要终点
Zhi Tong Cai Jing· 2025-08-13 03:06
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]
港股异动 | 开拓药业-B(09939)盘中涨超3% GT20029凝胶治疗痤疮II期临床试验达到主要终点
Zhi Tong Cai Jing· 2025-08-13 03:05
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]
药品股集体上扬 “医保双目录”申报药品首次亮相 推动“多层次+创新支持”战略转型
Zhi Tong Cai Jing· 2025-08-13 02:56
Group 1 - Pharmaceutical stocks collectively surged, with notable increases in companies such as Deqi Pharmaceutical-B (up 13.53% to HKD 6.04), Jiuyuan Gene (up 7.89% to HKD 11.76), and others [1] - The National Healthcare Security Administration announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalogs, revealing that 534 drugs passed the basic insurance catalog review and 121 drug generic names passed the commercial insurance innovative drug catalog review [1] - High-priced innovative drugs, including CAR-T therapies, are seeking inclusion in the commercial insurance innovative drug catalog, aiming for diversified payment methods for innovative drugs [1] Group 2 - The core breakthrough of the 2025 plan is the establishment of a "Basic Insurance + Commercial Insurance Innovative Drug" dual-track system, which aims to alleviate pressure on basic insurance funds while meeting multi-tiered demands [2] - The plan includes a new price negotiation mechanism and a team of commercial insurance experts, reflecting policy coordination for innovative drug development, although it also increases process complexity [2] - Overall, this represents a strategic shift in healthcare policy from "basic coverage" to "multi-tiered + innovative support," balancing accessibility and sustainability [2]
港股异动 | 药品股集体上扬 “医保双目录”申报药品首次亮相 推动“多层次+创新支持”战略转型
智通财经网· 2025-08-13 02:43
Group 1 - Pharmaceutical stocks collectively surged, with notable increases in shares of companies such as Deqi Pharmaceutical-B (up 13.53% to HKD 6.04), Jiuyuan Gene (up 7.89% to HKD 11.76), and others [1] - The National Healthcare Security Administration announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalogs, revealing that 534 drugs passed the basic medical insurance review and 121 drugs passed the commercial insurance innovative drug catalog review [1] - High-priced innovative drugs, including CAR-T therapies, are seeking inclusion in the commercial insurance innovative drug catalog, aiming for diversified payment methods for innovative drugs [1] Group 2 - The core breakthrough of the 2025 plan is the establishment of a "basic medical insurance + commercial insurance innovative drug" dual-track system, which aims to alleviate pressure on basic medical insurance funds while meeting multi-tiered demands [2] - The new pricing negotiation mechanism and the establishment of a commercial insurance expert team reflect policy coordination for innovative drug development, although the complexity of the process has increased [2] - Overall, this represents a strategic shift in medical insurance from "basic coverage" to "multi-tiered + innovative support," balancing accessibility and sustainability [2]
开拓药业-B:GT20029凝胶治疗痤疮中国II期临床试验达到主要终点
Zhi Tong Cai Jing· 2025-08-11 22:54
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]
开拓药业-B(09939):GT20029凝胶治疗痤疮中国II期临床试验达到主要终点
智通财经网· 2025-08-11 22:52
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].
开拓药业-B(09939.HK):GT20029凝胶治疗痤疮中国II期临床试验达到主要终点
Ge Long Hui· 2025-08-11 22:40
格隆汇8月12日丨开拓药业-B(09939.HK)发布公告,有关GT20029凝胶治疗痤疮的中国II期临床试验("该 项II期临床试验"),其已于2024年6月17日完成首例受试者入组。其自主研发的新型靶向雄激素受体 ("AR")的蛋白降解嵌合体("PROTAC")化合物GT20029治疗痤疮的该项II期临床试验读出顶线数据。数据 显示,该项II期临床试验成功达到主要研究终点,结果具有统计学显著性及临床意义,且有效性、安全 性和药代动力学特征均表现出色,并确定III期临床试验的推荐剂量为0.5%。详细的顶线结果资料未来 预计在学术期刊或学术会议上予以公布。 GT20029作为公司核心产品之一,是公司基于自有的PROTAC平台自主开发,有潜力成为雄激素性脱发 及痤疮的新一代治疗药物。其自开发以来始终保持领先地位,是全球范围内首款完成II期临床试验的外 用PROTAC化合物。公司正在制定GT20029治疗痤疮的未来临床策略,包括开启治疗痤疮中国III期临床 试验,进一步扩大在外用PROTAC领域的先发优势。 Winlevi®(clascoterone 1%,乳膏剂)是美国食品和药物管理局(FDA)近40年来批准的 ...