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亚盛医药:新型Bcl-2抑制剂利生妥®获批,是公司第二个获批上市、进入商业化阶段的原创新药
Cai Jing Wang· 2025-07-11 02:45
目前,亚盛医药正在开展利沙托克拉四项全球注册III期临床研究,分别为获美国FDA许可的治疗经治CLL/SLL患者的 GLORA研究;治疗初治CLL/SLL患者的GLORA-2研究;治疗新诊断老年或体弱急性髓系白血病(AML)的GLORA-3研 究;以及治疗新诊断中高危骨髓增生异常综合徵(MDS)患者的GLORA-4研究。 Bcl-2抑制剂的出现为CLL/SLL的治疗带来了进一步革新。Bcl-2是一种凋亡抑制因子,在许多恶性血液肿瘤特别是 CLL/SLL中过度表达,是肿瘤细胞逃避凋亡的重要机制。 然而,Bcl-2靶点成药性难度很高,主要因为其作用机制为蛋白-蛋白相互作用(Protein-protein Interaction, PPI),靶点 结合界面较大,很难设计小分子去抑制并发挥阻断作用。 近日,亚盛医药发布新型Bcl-2抑制剂利沙托克拉(利生妥)正式获中国国家药品监督管理局批准,用于治疗成人慢性淋巴 细胞白血病╱小淋巴细胞淋巴瘤患者的自愿性公告。 当中介绍,公司自主研发的新型Bcl-2选择性抑制剂利生妥®(通用名:利沙托克拉;研发代码:APG-2575)获中国国 家药品监督管理局(NMPA)附条件批准上市 ...
亚盛医药上涨3.85%,报42.94美元/股,总市值37.47亿美元
Jin Rong Jie· 2025-07-09 13:44
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、工伤保险和生育保险药 品目录(2022年)》。该品种还获得了美国FDA快速通道资格、孤儿药资格认定、以及欧盟孤儿药资格认 定。截至目前,公司共有4个在研新药获得16项FDA和1 ...
亚盛医药上涨4.14%,报41.5美元/股,总市值36.15亿美元
Jin Rong Jie· 2025-07-03 13:44
Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma (AAPG), with a total revenue of 981 million RMB, representing a year-on-year increase of 341.77%, and a net profit of -405 million RMB, showing a year-on-year growth of 56.2% as of December 31, 2024 [1][2][3] Group 2 - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, and was listed on the Hong Kong Stock Exchange on October 28, 2019 [2] - The company has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway, with a pipeline of nine clinical-stage Class 1 small molecule drugs [2] - Ascentage Pharma's core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2] - The company has received multiple orphan drug designations and fast track designations from the FDA for four investigational new drugs, demonstrating its strong research and development capabilities [2] - Ascentage Pharma has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, and is committed to addressing unmet clinical needs for patients worldwide [2]
亚盛医药上涨4.17%,报38.7美元/股,总市值33.72亿美元
Jin Rong Jie· 2025-06-24 13:48
本文源自:金融界 6月24日,亚盛医药(AAPG)开盘上涨4.17%,截至21:30,报38.7美元/股,成交5.31万美元,总市值33.72 亿美元。 作者:行情君 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 ...
亚盛医药-B(6855.HK):创新产品亮相ASCO大会 核心管线带动公司成长
Ge Long Hui· 2025-06-21 02:52
机构:中信建投证券 研究员:贺菊颖/袁清慧 核心观点 在2025 年ASCO 大会上,公司核心产品Lisaftoclax 展示了在维奈克拉耐药后患者中的研究结果。在28 例既往接受维奈克拉治疗的患者中,22 例可评估疗效患者的ORR 为31.8%,其中22.8%的患者CR/Cri, 同时在15 例CMML 患者中,ORR 为80%。整体看,产品Lisaftoclax 在维奈克拉耐药后的肿瘤患者中展 现了优异疗效,产品基本面良好,安全性优异,看好药物后续临床进展以及国际化进展。 事件 2025 年6 月3 日,公司发布公告,核心产品Lisaftoclax 针对维奈克拉治疗失败患者的口头报告在ASCO 大会上展示。 简评 Lisaftoclax 疗效数据优异,产品竞争力强 在ASCO 大会上,公司公布核心产品Lisaftoclax 针对维奈克拉治疗失败患者的最新数据。截至2025 年4 月,在28 例既往维奈克拉耐药的复发/难治AML/混合表型急性白血病(MPAL)患者中,疗效可评估的 患者有22 例,总反应率(ORR)为31.8%(7/22),其中22.8%的患者CR/ CR 伴血细胞未完全恢复 (Cri);4 ...
亚盛医药上涨10.46%,报34.95美元/股,总市值30.45亿美元
Jin Rong Jie· 2025-06-18 14:33
Core Viewpoint - As of June 18, 2023, AAPG's stock price increased by 10.46%, reaching $34.95 per share, with a total market capitalization of $3.045 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, focusing on global markets, 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 included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (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 participated in 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 biotech 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].
亚盛医药上涨3.07%,报25.15美元/股,总市值21.91亿美元
Jin Rong Jie· 2025-06-02 13:59
Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma, with a total revenue of 981 million RMB, representing a year-on-year increase of 341.77%, and a net profit of -405 million RMB, showing a growth of 56.2% [1][2]. Group 2 - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, with a strong emphasis on drug discovery and clinical development [2]. - The company 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]. - Ascentage Pharma has a pipeline of nine clinical-stage first-in-class small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway, and is the only company globally with clinical development in this area [2]. - The core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2]. - The company has received multiple designations from the FDA, including orphan drug status and fast track designation for four investigational drugs, and has established collaborations with leading biotech and pharmaceutical companies [2].
亚盛医药上涨2.43%,报25.02美元/股,总市值21.80亿美元
Jin Rong Jie· 2025-05-29 13:51
Core Viewpoint - As of May 29, 2023, AAPG's stock price increased by 2.43%, reaching $25.02 per share, with a total market capitalization of $2.18 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]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on global markets, 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, positioning itself at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline and Clinical Development - 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]. - Currently, the company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. Key Product and Regulatory Approvals - The core product, Orebatinib (brand name: Nairike), used for treating chronic myeloid leukemia, has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has been approved for sale in China [2]. - Nairike has also been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. - The product has received fast track designation, orphan drug designation from the FDA, and orphan drug designation from the EU [2]. Research and Development Capabilities - AAPG has undertaken multiple national science and technology major projects, including five related to "Major New Drug Creation" and one related to "Major Infectious Disease Prevention and Control" [2]. - The company has established a global intellectual property layout and formed partnerships with leading biotech and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - AAPG is building a high-standard commercialization and marketing team while continuously enhancing its R&D capabilities to accelerate the clinical development of its product pipeline [2].
亚盛医药上涨2.29%,报25.88美元/股,总市值22.53亿美元
Jin Rong Jie· 2025-05-06 14:46
Group 1 - The core viewpoint of the article highlights the significant financial growth of Ascentage Pharma (AAPG), with a notable increase in revenue and net profit for the year ending December 31, 2024 [1][2] - Ascentage Pharma's total revenue reached 981 million RMB, representing a year-on-year growth of 341.77% [1] - The company's net profit attributable to shareholders was -405 million RMB, showing a year-on-year increase of 56.2% [1] Group 2 - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2] - The company has established a drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2] - Ascentage Pharma has a pipeline of nine clinical-stage Class 1 small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway [2] - The core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from China's National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2] - The company is conducting over 40 clinical trials across China, the US, Australia, and Europe [2] - Ascentage Pharma has received multiple designations from the FDA and the EU for its investigational drugs, including orphan drug status and fast track designation [2] - The company has established collaborations with leading biotech and pharmaceutical companies and academic institutions globally [2] - Ascentage Pharma aims to enhance its R&D capabilities and accelerate the clinical development of its product pipeline to meet unmet clinical needs [2]
亚盛医药上涨4.34%,报25.25美元/股,总市值21.98亿美元
Jin Rong Jie· 2025-04-30 14:25
Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma (AAPG), with a revenue increase of 341.77% year-on-year and a net profit increase of 56.2% [1][2] - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, with a strong emphasis on apoptosis pathway drug development [2] - The company has established a pipeline of nine clinical-stage first-class small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway, and is conducting over 40 clinical trials globally [2] Group 2 - Ascentage Pharma's core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and has been included in the National Basic Medical Insurance Drug List [2] - The company has achieved multiple designations from the FDA, including orphan drug status and fast track designation for four investigational new drugs, demonstrating its strong regulatory engagement [2] - Ascentage Pharma has formed global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research capabilities and market presence [2]