对此，亚盛医药首席医学官翟一帆博士表示： 作为起源于造血干细胞的髓系克隆增殖性疾病， MDS具有显著的年龄相关性特征，全球流行病学研究 显示其发病率随年龄呈指数级增长(65岁以上人群年发病率达22/10万)，中位诊断年龄达70岁1，且>75% 患者病情复杂常伴有至少两种合并症2。该疾病的核心风险在于克隆演化导致的急性髓系白血病(AML) 转化，其中中高危组(IPSS-R高危/极高危)患者5年内AML转化率高达40-60%3，转化后预后极差，中位 生存期不足6个月4。 去甲基化药物作为中高危MDS的一线标准方案，总缓解率(ORR)仅 30-40%5，完全缓解(CR)率仅10- 17%，且中位缓解持续时间仅9-12个月6, 8，治疗应答不足;allo-HSCT虽可提供治愈可能，但受限于患者 中位年龄、复杂病情、MDS常见的造血干细胞储备衰退及移植相关死亡率(TRM)达25-35%，仅5-10%适 宜患者可接受移植7，根治手段受限。IPSS-R高危患者5年生存率仍停滞于16-24%8，亟待创新性疗法改 写治疗范式。 利生妥®是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白，恢复癌细胞 ...

利生妥®是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白，恢复癌细胞 的正常凋亡过程，从而达到治疗肿瘤的目的。目前，该产品已在中国获批上市，用于既往经过至少包含 布鲁顿酪氨酸激酶(BTK)抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 (CLL/SLL)患者。利生妥®为中国首个获批上市的国产原研Bcl-2抑制剂。 作为利生妥®在欧美监管机构获批的第二个全球注册III期研究，GLORA-4研究(NCT06641414)在多国家 多中心同步入组，将加速新药上市进程。利生妥®也是目前国际上唯一正推进中高危MDS注册III期临床 的Bcl-2抑制剂。该研究有望打破中高危MDS领域长期存在的临床空白，是利生妥®全球临床开发的又 一重要里程碑。 据了解，GLORA-4研究为国际多中心、随机、双盲III期临床试验，旨在评估利生妥®联合AZA对比安 慰剂联合AZA在新诊断的成人HR-MDS患者中的疗效及安全性。GLORA-4研究已于2024年获CDE临床 试验许可。目前该研究正在全球同步推进患者入组，并已完成中国及欧洲地区的首例患者入组。全球主 要研究者(Leading P ...

点击蓝字，关注我们 今日上午港股 1. 亚盛医药-B(06855)高开逾5%， 亚盛医药公告，公司自主研发的利生妥治疗中高危MDS III期临床研究 获美国FDA和欧洲EMA批准。 2. 海吉亚医疗(06078)盈警后跌超5%， 8月15日，海吉亚医疗宣告，预计中期净利润同比下降约34%至 39%，主要是由于集采、DRG支付改革、宏观经济等影响，以及新开业医院折旧摊销增加的影响。 3. 华虹半导体(01347)现跌超6%， 8月17日晚，华虹公司公告，正在筹划以发行股份及支付现金的方式购 买上海华力微电子有限公司控股权，有望解决同业竞争。 4. 中慧生物-B(02627)涨超8%， 集团自主研发的重组呼吸道合胞病毒疫苗IND申请中美双报获批。 5. 网龙(00777)涨超10%， 8月15日，网龙旗下创奇思与中科闻歌成立战略联盟，共同推动"雅意"大模型 等AI技术出海。 6. 长城汽车(02333)涨超12%， 据长城汽车官微消息，8月16日巴西工厂正式竣工投产，生产线全面启 动，初期产能为每年3万辆。 7. 阅文集团(00772)再涨超20%， 阅文集团上半年业绩略超预期，主要受惠于授权业务增长、短剧表现稳 ...

智通财经APP讯，亚盛医药-B(06855)发布公告，公司自主研发的Bcl-2选择性抑制剂利沙托克拉(商品 名：利生妥;研发代码：APG-2575)联合阿扎胞苷(AZA)一线治疗新诊断的中高危骨髓增生异常综合症 (HR-MDS)患者的全球注册III期临床研究(GLORA-4)获美国食品药品监督管理局(FDA)和欧洲药品管理 局(EMA)同意开展。作为利生妥在欧美监管机构获批的第二个全球III期研究， GLORA-4 (NCT06641414)在多国家多中心同步入组，将加速新药上市进程。截止本公告日期，利生妥也是国际上 唯一正推进中高危MDS注册III期临床的Bcl-2抑制剂。该研究有望打破中高危MDS领域长期存在的临床 空白，是利生妥全球临床开发的又一重要里程碑。 GLORA-4研究为国际多中心、随机、双盲III期临床试验，旨在评估利生妥联合AZA对比安慰剂联合 AZA在新诊断的成人HR-MDS患者中的疗效及安全性。 GLORA-4研究已于2024年获CDE临床试验许 可。目前该研究正在全球同步推进患者入组，并已完成中国及欧洲地区的首例患者入组。全球主要研究 者(Leading PI)为美国得克萨斯大学MD安 ...

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的全部內容概不負責，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。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） （股份代號：6855） 自願公告 亞盛醫藥利生妥®一線治療中高危MDS患者的全球註冊III期臨床研究 獲美國FDA和歐洲EMA批准 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司自主研發的Bcl-2選 擇性抑制劑利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）聯合阿扎胞 苷(AZA)一線治療新診斷的中高危骨髓增生異常綜合症(HR-MDS)患者的全球註 冊III期臨床研究(GLORA-4)獲美國食品藥品監督管理局(FDA)和歐洲藥品管理 局(EMA)同意開展。作為利生妥®在歐美監管機構獲批的第二個全球III期研究， GLORA-4 (NCT06641414)在多國家多中心同步入組，將加速新藥上市進程。截止 本公告日期，利生妥®也是國際上唯一正推進中高危MDS註冊I ...

Core Viewpoint - As of August 13, 2023, AAPG's stock price increased by 3.23% to $41.5 per share, with a total market capitalization of $3.858 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][3]. Company Overview - AAPG is a biopharmaceutical company based in China with a global focus, dedicated to developing innovative drugs for the treatment of cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline - The company has established a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is the only innovative company globally with clinical development products in all key proteins of the apoptosis pathway [2]. - The core product, Aorebatin (brand name: Nairike), has been approved in China and is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. Clinical Trials and Regulatory Approvals - The company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - AAPG has received multiple designations from the FDA, including orphan drug status and fast track designation for four investigational new drugs [2]. - The company has undertaken several national science and technology major projects, including five under the "Major New Drug Creation" initiative [2]. Collaborations and Talent - AAPG has established global collaborations with leading biotechnology and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - The company has built an international team with extensive experience in original drug research and clinical development [2].

Group 1 - The Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index (HSSCPB) increased by 0.02%, with notable stock performances including Jingtai Holdings (02228) up 7.38% and Fosun Pharma (02196) up 6.00% [3] - The Hong Kong Innovative Drug Selection ETF (520690) rose by 0.52%, reaching a latest price of 0.97 yuan, with a trading volume of 240.45 million yuan and a turnover rate of 0.62% [3] - Jingtai Holdings announced an expected comprehensive income of no less than 500 million yuan for the six months ending June 30, 2025, representing an increase of at least 387% compared to the same period in 2024 [3] Group 2 - The Hong Kong Innovative Drug Selection ETF reached a new high in scale at 385 million yuan and a new high in shares at 399 million [4] - The ETF has seen continuous net inflows over the past three days, with a maximum single-day net inflow of 22.93 million yuan, totaling 42.28 million yuan [4] - The ETF's management fee is 0.50% and the custody fee is 0.10%, which are among the lowest in comparable funds [5] Group 3 - The HSSCPB index aims to reflect the performance of Hong Kong-listed companies involved in innovative drug research, development, and production [5] - The top ten weighted stocks in the HSSCPB index account for 78.05% of the total index weight, including companies like BeiGene (06160) and WuXi Biologics (02269) [5]

（股份代號：6855） 董事會會議通告 亞盛醫藥集團（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）謹 此宣佈，本公司將於2025年8月20日（星期三）舉行董事會會議，藉以考慮及（如 合適）批准（其中包括）本集團截至2025年6月30日止六個月之未經審核中期業 績，以及其發佈。 承董事會命 亞盛醫藥集團 主席兼執行董事 楊大俊博士 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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對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。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） 中華人民共和國蘇州，2025年8月8日 於本公告日期，董事會包括主席兼執行董事楊大俊博士；非執行董事王少萌博士 及呂大忠博士；以及獨立非執行董事葉長青先生、任為先生、David Sidransky博 士、Marina S. Bozilenko女士、Debra Yu博士及Marc E. Lippman, MD。 ...

Core Viewpoint - As of August 7, 2023, AAPG's stock price increased by 2.38% to $43.00 per share, with a total market capitalization of $3.997 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][2]. Group 1: Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2]. Group 2: Product Pipeline and Clinical Development - The company has a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. - The core product, Orebatinib (brand name: Nairike), has received priority review and breakthrough therapy designation from the China National Medical Products Administration and has been approved for sale in China [2]. Group 3: Regulatory Approvals and Collaborations - Orebatinib has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China and has received multiple designations from the FDA, including orphan drug status and fast track designation [2]. - AAPG has been involved in several national science and technology major projects, including five projects under the "Major New Drug Creation" initiative [2]. - The company has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research and development capabilities [2].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年7月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 亞盛醫藥集團 | | | | 呈交日期: | 2025年8月6日 | | | | I. 法定/註冊股本變動 | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06855 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,00 ...