Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (GLORA-4) for the Bcl-2 selective inhibitor, Lisatoclax (APG-2575), in combination with Azacitidine (AZA) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, marking a significant milestone in the drug's global clinical development [1][2]. Group 1: Clinical Trial Details - GLORA-4 is an international, multicenter, randomized, double-blind Phase III clinical trial aimed at evaluating the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2]. - The trial has received clinical trial approval from the CDE in 2024 and is currently enrolling patients globally, with the first patients enrolled in China and Europe [2]. - Leading principal investigators include Professor Garcia Manero from MD Anderson Cancer Center and Professor Huang Xiaojun from Peking University [2]. Group 2: Disease Background and Treatment Challenges - Myelodysplastic syndromes (MDS) are hematopoietic clonal proliferative diseases with significant age-related characteristics, showing an exponential increase in incidence with age, particularly affecting those over 65 years [2]. - The core risk of MDS is the transformation to acute myeloid leukemia (AML), with a 5-year transformation rate of 40-60% in high-risk patients, leading to poor prognosis [2]. Group 3: Current Treatment Landscape - Current first-line treatment options for high-risk MDS, such as hypomethylating agents (HMAs), have an overall response rate (ORR) of only 30-40% and a complete response (CR) rate of 10-17%, with a median duration of response of 9-12 months [3]. - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) offers potential cure but is limited by patient age, complex conditions, and a transplant-related mortality (TRM) rate of 25-35%, making only 5-10% of patients suitable for transplantation [3]. Group 4: Drug Profile and Efficacy - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by the company, designed to restore normal apoptosis in cancer cells by selectively inhibiting the Bcl-2 protein [3]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy [3]. - Preliminary data from the 2024 American Society of Hematology (ASH) and 2025 American Society of Clinical Oncology (ASCO) meetings indicate that Lisatoclax combined with AZA achieved an ORR of 75% in treatment-naive MDS, significantly outperforming HMAs, with a favorable safety profile [4].

Core Viewpoint - The announcement highlights the approval of the global Phase III clinical trial (GLORA-4) for the Bcl-2 selective inhibitor, lisatoclax (brand name: Lishengtuo), in combination with azacitidine (AZA) for treating newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, marking a significant milestone in the drug's global clinical development [1][2]. Company Summary - As of the announcement date, lisatoclax is the only Bcl-2 inhibitor advancing to a Phase III clinical trial for high-risk MDS globally, indicating its unique position in the market [1]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one prior systemic therapy, making it the first domestically developed Bcl-2 inhibitor approved in China [3]. Industry Summary - The GLORA-4 study is an international, multicenter, randomized, double-blind Phase III trial aimed at evaluating the efficacy and safety of lisatoclax combined with AZA compared to placebo plus AZA in newly diagnosed adult HR-MDS patients [2]. - MDS is characterized by significant age-related features, with an incidence rate that increases exponentially with age, particularly affecting individuals over 65 years, where the annual incidence rate reaches 22 per 100,000 [2]. - The core risk of MDS lies in the clonal evolution leading to acute myeloid leukemia (AML) transformation, with a 5-year transformation rate of 40-60% for high-risk patients, resulting in a median survival of less than 6 months post-transformation [2]. - Current first-line treatments for high-risk MDS, such as hypomethylating agents (HMAs), show a total response rate of only 30-40% and a complete response rate of 10-17%, highlighting the urgent need for breakthrough therapies [3]. - Recent data from the 2024 American Society of Hematology (ASH) annual meeting and the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicate that lisatoclax combined with AZA achieved an overall response rate of 75% in treatment-naive MDS, significantly outperforming HMAs [4].

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 ...

本文源自：金融界 财务数据显示，截至2024年12月31日，亚盛医药收入总额9.81亿人民币，同比增长341.77%；归母净利 润-4.05亿人民币，同比增长56.2%。 资料显示，亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局新药审评中心(CDE)纳入优先审评和突破性治疗品种,并已在中国 获批,是公司的首个上市品种。目前,耐立克已被成功纳入《国家基本医疗保险、工伤 ...

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 - Morgan Stanley reports that Ascentage Pharma (06855) has seen a year-to-date stock price increase of approximately 83%, aligning with the strong performance of the Hang Seng Healthcare Index, which has risen about 78% [1] Group 1: Stock Performance and Target Price - Morgan Stanley has updated its model for Ascentage Pharma following discussions at the recent Sino-US Biotechnology Forum, considering the latest developments in the company's product pipeline [1] - The target price for Ascentage Pharma has been significantly raised by 79% from the previous HKD 52 to HKD 93, while maintaining an "Overweight" rating [1] Group 2: Key Assets and Sales Forecast - The firm remains optimistic about the company's key assets, "olverembatinib" and "lisaftoclax," which are expected to drive strong product sales this year [1] - There is an improved outlook for the overseas potential of "lisaftoclax," particularly in light of the failure of "venetoclax" to demonstrate overall survival benefits in myelodysplastic syndromes (MDS), along with the drug's market approval scope in China exceeding expectations [1]

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 ...