Ascentage Pharma Group International(AAPG)

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亚盛医药新型Bcl-2抑制剂在国内获批上市
Xin Hua Cai Jing· 2025-07-11 06:55
Core Viewpoint - The approval of the new Bcl-2 selective inhibitor, Lisengmato, by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, making it the first domestically developed Bcl-2 inhibitor to be conditionally approved for marketing and the second globally [2][3]. Group 1: Product Development and Market Position - Lisengmato is an oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore the normal apoptosis process in tumor cells, thereby treating tumors [2]. - The approval of Lisengmato highlights Ascentage Pharma's strong innovation capabilities and establishes its leading position in the hematological oncology field [4]. - The company has been engaged in Bcl-2 target drug development for over 30 years, indicating deep expertise in this area [2]. Group 2: Clinical Relevance and Market Need - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a prevalent blood cancer in aging populations, with an increasing incidence in China despite lower rates compared to Europe and the U.S. [3]. - The introduction of Bcl-2 inhibitors like Lisengmato addresses unmet clinical needs in the treatment of CLL/SLL, providing new therapeutic options for patients facing challenges such as drug resistance and complex long-term management [3]. - Ascentage Pharma is conducting four global Phase III clinical trials for Lisengmato, indicating ongoing commitment to expanding its clinical applications [4].
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
Core Viewpoint - The approval of the novel Bcl-2 inhibitor, Lisatoclax (APG-2575), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, as it becomes the first domestically developed Bcl-2 inhibitor approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China and the second globally [1][2]. Group 1: Product Approval and Significance - Lisatoclax is the first Bcl-2 inhibitor approved in China for CLL/SLL, highlighting its potential in the treatment landscape [2][3]. - The drug is expected to restore normal apoptosis in tumor cells by selectively inhibiting the Bcl-2 protein, offering new treatment options for patients [2][3]. - The approval signifies Ascentage Pharma's commitment to global clinical innovation and represents a key milestone in its journey to enter the global market [2]. Group 2: Clinical Research and Development - Ascentage Pharma is conducting four global Phase III clinical trials for Lisatoclax, targeting various patient groups, including those with previously treated CLL/SLL and newly diagnosed acute myeloid leukemia (AML) [2]. - The ongoing studies include the GLORA study for treated CLL/SLL patients and GLORA-2 for treatment-naive CLL/SLL patients, among others [2]. Group 3: Challenges in Bcl-2 Inhibition - The development of Bcl-2 inhibitors has been challenging due to the complex nature of protein-protein interactions and the need for drugs to penetrate cellular membranes and mitochondrial membranes [3]. - Prior to Lisatoclax, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in addressing this treatment gap [3].
今年医保目录调整工作方案公布;亚盛医药拿下全球第二个Bcl-2抑制剂 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-10 23:21
Group 1 - The National Healthcare Security Administration has released the adjustment plan for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, which includes a new commercial health insurance innovative drug catalog, potentially accelerating the commercialization of innovative drugs and enhancing investor confidence in the pharmaceutical sector [1] Group 2 - WuXi AppTec expects a net profit of approximately 8.561 billion yuan for the first half of 2025, representing a year-on-year increase of about 101.92%, driven by both core business and non-recurring gains, indicating strengthened competitiveness in the global pharmaceutical market [2] Group 3 - As the second Bcl-2 inhibitor approved globally, Ascentage Pharma's "Lisenglitazone" is expected to capture market share quickly, enhancing investor confidence and boosting the company's valuation in the innovative drug sector [3] Group 4 - Federated Pharmaceutical's innovative drug "UBT37034 injection" has received FDA approval for clinical trials targeting overweight or obesity, indicating significant market potential and enhancing the company's competitiveness in the innovative drug field [4] Group 5 - North China Pharmaceutical expects a net profit of approximately 124 million yuan for the first half of 2025, a year-on-year increase of around 72%, attributed to improved management and operational efficiency, which strengthens investor confidence in the company's future growth [5]
Ascentage Pharma Announces Its Novel Bcl-2 Inhibitor Lisaftoclax Approved by China NMPA, Ushering in a New Era for the Treatment of CLL/SLL
Globenewswire· 2025-07-10 13:30
Core Viewpoint - Ascentage Pharma's novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), has received conditional approval from China's National Medical Products Administration (NMPA) for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, marking it as the first Bcl-2 inhibitor approved for this indication in China and the second globally [1][3][7] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a rich pipeline of innovative drug candidates, including inhibitors targeting key proteins in the apoptotic pathway [10][11] - The approval of lisaftoclax represents a significant milestone in the company's development efforts, following its first commercialized drug, olverembatinib [2][10] Product Details - Lisaftoclax is an orally administered small-molecule Bcl-2 selective inhibitor designed to restore normal apoptosis in cancer cells by blocking the antiapoptotic protein Bcl-2 [2][5] - The drug has demonstrated broad therapeutic potential in various hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combination therapies [2][3] Clinical Study Insights - The approval was based on a pivotal Phase II study (APG2575CC201) that evaluated the efficacy and safety of lisaftoclax in patients with relapsed or refractory CLL/SLL, achieving a compelling overall response rate (ORR) that met the prespecified endpoint [3][4] - Lisaftoclax exhibited a favorable safety profile, with no occurrences of tumor-lysis syndrome (TLS) and manageable hematologic and non-hematologic toxicities [3][4] Market Context - CLL/SLL is a common hematologic malignancy, particularly affecting older populations, with over 100,000 new diagnoses globally each year [4] - In China, the incidence of CLL/SLL is rising, necessitating safer and more effective treatment options beyond the current primary therapies, such as BTK inhibitors, which have limitations including high relapse rates and associated toxicities [4][5][6] Future Development Plans - Ascentage Pharma is conducting four global registrational Phase III trials for lisaftoclax, including studies in combination with BTK inhibitors and in various hematologic malignancies [7][13] - The company aims to accelerate the global development of lisaftoclax to address unmet clinical needs and expand its therapeutic applications [7][13]
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
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][3] - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, and is listed on the Hong Kong Stock Exchange [2][3] - The company has a robust pipeline with nine clinical-stage first-class small molecule drugs targeting key proteins in the apoptosis pathway, positioning it at the forefront of global drug development in this area [2][3] 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 is 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, indicating strong regulatory support for its product pipeline [2] - Ascentage Pharma has established global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research capabilities and market reach [2]
亚盛医药(06855)任命Veet Misra博士为首席财务官 任命黄智为全球企业发展&财务高级副总裁
智通财经网· 2025-07-08 03:58
黄智先生拥有20多年的全球跨国企业管理经验,在持续改善财务业绩、业务和运营优化及全球化运营方 面尤其具有丰富经验。加入亚盛医药之前,黄智先生担任百济神州大中华区和亚太区首席财务官、全球 技术运营和全球商业财务负责人。在百济任职期间,他通过完整的全面预算管理及合理的全球布局资源 优化,持续改善公司财务状况。在此之前黄智先生曾任职于诺华制药多国家/区域财务负责人。黄智先 生拥有美国道林商学院银行与金融专业的MBA学位。 亚盛医药首席财务官Veet Misra博士指出,加入亚盛医药担任首席财务官,我深感振奋。作为全球细胞 凋亡靶向治疗领域的领导者,亚盛医药"港美双重上市"的里程碑更彰显了国际资本市场的认可。我期待 与公司共同努力,加速公司在创新管线的全球开发,为患者与股东创造可持续价值。 Misra博士拥有20多年的投资银行从业经验。加入亚盛医药之前,他在知名金融公司Cantor Fitzgerald担 任医疗健康投行部董事总经理,负责生物制药领域业务。在此之前,他还曾就职于华利安国际投资银行 (Houlihan Lokey)和加拿大皇家银行资本市场(RBC Capital Markets)的生命科学投行部。在其投 ...
Ascentage Pharma Appoints Dr. Veet Misra as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance
Globenewswire· 2025-07-07 23:30
Core Viewpoint - Ascentage Pharma Group International has appointed Veet Misra, Ph.D., as Chief Financial Officer and Eric Huang as Senior Vice President of Global Corporate Development and Finance, aiming to accelerate its global growth strategy in the biopharmaceutical sector [1][2][3] Management Appointments - Dr. Veet Misra brings over 20 years of investment banking experience, particularly in the biopharmaceutical sector, and holds a Ph.D. in Molecular Biology and an MBA in Finance & Strategy [4][5] - Mr. Eric Huang has over 20 years of experience in the global pharmaceutical industry, previously serving as CFO for Greater China and Asia-Pacific at Beigene, and holds an MBA in Finance [5] Company Strategy and Growth - The company is entering a notable growth phase, with the new executives expected to enhance its global strategy and operational excellence [2][3] - Ascentage Pharma is focused on becoming a leading fully integrated global biopharmaceutical company, leveraging its dual listing on the Hong Kong Stock Exchange and Nasdaq [2][4] Product Pipeline - Ascentage Pharma has a robust pipeline of innovative drug candidates targeting cancers, including apoptosis-targeted therapies and next-generation kinase inhibitors [6][7] - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is undergoing global Phase III trials [8] - Another key asset, lisaftoclax, is a Bcl-2 inhibitor for hematologic malignancies, with its NDA accepted for Priority Review in China and multiple global Phase III trials ongoing [9] Partnerships and Collaborations - The company has established partnerships with leading pharmaceutical firms such as Takeda, AstraZeneca, Merck, and Pfizer, enhancing its research and development capabilities [10]
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
Core Viewpoint - As of June 24, 2023, AAPG's stock price increased by 4.17%, reaching $38.7 per share, with a total market capitalization of $3.372 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 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 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 Fast Track designation, Orphan Drug designation, and two designations for pediatric rare diseases [2]. Research and Development - AAPG has undertaken several national science and technology major projects, including five 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 capabilities [2]. - AAPG is committed to improving its R&D capabilities and accelerating the clinical development of its product pipeline to meet unmet clinical needs globally [2].
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].