Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial for lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [11][12] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is the second registrational Phase III trial for lisaftoclax to receive clearance from both the FDA and EMA, with simultaneous patient enrollment across multiple countries [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment for higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the urgent need for innovative therapies [5][9] Clinical Data - Earlier studies of lisaftoclax in combination with azacitidine showed an ORR of 75%, significantly higher than HMAs alone, with a favorable safety profile and low incidence of severe hematologic toxicities [8][9] - The combination therapy demonstrated a low requirement for dose adjustments and no treatment-related mortalities within 60 days, indicating its potential as a superior treatment option [8][9] Expert Commentary - Experts emphasize the challenges in treating higher-risk MDS due to the limited efficacy of current therapies and the absence of breakthrough treatments in the last two decades, underscoring the importance of the GLORA-4 study [9][10]

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial of lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer [1][11] - The company has a robust pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [12][14] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is notable as it is the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment of higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5][9] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the need for more effective treatments [5][9] Lisaftoclax Profile - Lisaftoclax is a proprietary, orally administered Bcl-2 selective inhibitor that has shown promising clinical benefits and tolerability in earlier studies [6][8] - The drug is already approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [7][14] Clinical Data - Clinical data presented at major conferences indicated an ORR of 75% for the combination of lisaftoclax and azacitidine in treatment-naïve MDS, significantly higher than HMAs alone [8] - The combination therapy demonstrated a favorable safety profile with low incidence of severe hematologic toxicities [8][9] Global Collaboration - The GLORA-4 trial is being co-led by prominent researchers from leading institutions, including The University of Texas MD Anderson Cancer Center and Peking University [3][4]

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 ...

ROCKVILLE, Md. and SUZHOU, China, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced today that it will release its six months 2025 unaudited interim results and provide business updates at 7:00 pm Eastern Daylight Time (EDT) on August 20, 2025 / 7:00 am Hong Kong Time (HKT) on August 21, 2025. Analysts and investors are in ...

Summary of Ascentage Pharma's Conference Call Company Overview - **Company**: Ascentage Pharma - **Key Products**: Lisatoclax (2,575) and Olverembatinib (Aurebatinib) Industry Insights - **Market Focus**: Hematological malignancies, specifically targeting CLL (Chronic Lymphocytic Leukemia), MDS (Myelodysplastic Syndromes), and MM (Multiple Myeloma) [2][6] - **Competitive Landscape**: The market for BCL-2 inhibitors is competitive, with Lisatoclax being the second BCL-2 inhibitor globally approved, following Venetoclax [19] Core Points and Arguments - **Lisatoclax Development**: - Submitted for CLL indication in China and plans to expand into MDS and MM, which have less competition [2][6] - Expected to leverage safety advantages to capture market share [2] - Clinical trial data presented at ASCO 2025 showed an ORR of 83.3% in AML patients and 43% in difficult-to-treat AML patients [23] - **Olverembatinib Performance**: - Achieved sales of 241 million RMB in 2024, with expectations to double in 2025 [3] - Positioned as a third-generation TKI targeting T315I resistant patients, showing significant safety advantages over competitors [11][15] - **Collaboration with Takeda**: - A $1.3 billion licensing agreement was reached, with Takeda expected to exercise options post-2026 [5] - This partnership indicates recognition of Chinese-developed drugs by international firms [5] - **Research and Development Focus**: - Future R&D investments will prioritize overseas registration and domestic indication expansions for Lisatoclax [4] - Cash flow is projected to support these initiatives [4] Additional Important Insights - **Market Potential**: - Lisatoclax's peak sales potential is estimated between $3 billion to $4 billion globally [19] - Olverembatinib's peak sales in overseas markets could reach $2 billion to $3 billion, with domestic sales expected to approach 2 billion RMB [18] - **Competitive Advantages**: - Lisatoclax offers better safety and faster dose escalation compared to Venetoclax, enhancing patient compliance [19] - The strategic approach of entering the market with a cautious clinical trial design allows for quicker market capture [22] - **Management and Shareholder Structure**: - Led by Dr. Yang Dajun, with a strong management team experienced in drug development [7] - Takeda is a significant shareholder, reflecting confidence in Ascentage's capabilities [8] - **Future Outlook**: - Plans to expand into ALL (Acute Lymphoblastic Leukemia) with Philadelphia chromosome-positive patients, which could significantly boost sales [14] - The company is also exploring new product pipelines targeting solid tumors and hematological malignancies [9] This summary encapsulates the key insights from Ascentage Pharma's conference call, highlighting the company's strategic direction, product performance, and market opportunities.

Core Insights - Ascentage Pharma Group International is participating in the Evercore China Biotech Summit from August 19 to 21, 2025, in Shanghai, China [1][2] - The company is focused on addressing unmet medical needs in cancers and has developed a pipeline of innovative drug candidates [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company with a rich pipeline targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3] - The lead asset, olverembatinib, is the first third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is included in the China National Reimbursement Drug List [4] - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [5] Clinical Trials and Research - Ascentage Pharma is conducting several global registrational Phase III trials for olverembatinib and lisaftoclax, targeting various patient populations and conditions [4][5] - The company has established partnerships with leading biotechnology and pharmaceutical companies, enhancing its research and development capabilities [6]

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 ...

ROCKVILLE, Md. and SUZHOU, China, July 23, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced today that the Company's management will participate in the BTIG Virtual Biotechnology Conference being held on July 29- 30, 2025. Management will be participating in one-on-one investor meetings throughout the conference. Investors interes ...

Core Viewpoint - The recent approval of the novel Bcl-2 selective inhibitor, Lisangtuo (generic name: Lishatoclax), by Ascentage Pharma marks a significant advancement in the treatment of high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients, particularly those with TP53 mutations, who have limited treatment options and a poor prognosis [1][2][4] Group 1: Product and Market Impact - Lisangtuo is the first domestically developed Bcl-2 inhibitor approved in China and the second globally, indicating a milestone in the development of targeted therapies for hematological malignancies [1][2] - The mechanism of Bcl-2 inhibitors involves specifically binding to and inhibiting the Bcl-2 protein, which is overexpressed in certain malignancies, thereby restoring the apoptotic pathway in cancer cells [1][3] - The global incidence of CLL/SLL exceeds 100,000 new cases annually, with an increasing trend in China due to an aging population, despite a lower incidence compared to Western countries [2][3] Group 2: Clinical and Safety Profile - Clinical trial data supporting Lisangtuo's approval demonstrated a favorable safety profile, with no reported cases of tumor lysis syndrome, a serious adverse reaction previously associated with Bcl-2 inhibitors [3][4] - Traditional treatment options for high-risk patients, such as chemotherapy, yield a progression-free survival of only about 12 months, highlighting the need for more effective therapies [2][4] Group 3: Future Directions and Industry Trends - The emergence of new-generation Bcl-2 inhibitors addresses limitations of existing therapies, such as BTK inhibitors, by reducing drug interactions and allowing for potential intermittent dosing, which can alleviate long-term economic burdens and risks of resistance [5] - There are currently 42 Bcl-2 inhibitors in development globally, indicating a growing interest and investment in this therapeutic area [5] - The future goals for blood cancer treatment include moving towards non-chemotherapy approaches and achieving clinical cures in certain patient populations [5]

Core Insights - The successful launch of the drug Lisatoclax (also known as Lishengtuo) by Ascentage Pharma marks a significant milestone in the development of Bcl-2 inhibitors, breaking a nine-year monopoly held by AbbVie in this field [3][10] - The research on the Bcl-2 target has spanned over three decades, highlighting the challenges and complexities involved in drug development [3][5] - Ascentage Pharma aims to differentiate its products from existing therapies, focusing on innovative solutions to address unmet clinical needs [4][6] Company Overview - Ascentage Pharma's Lisatoclax is the first domestically developed Bcl-2 inhibitor in China and the second globally, showcasing the company's commitment to innovation [3][10] - The company has also developed another product, Olverembatinib (brand name: Nairike), which took 13 years to develop, further emphasizing its long-term investment in research [3] - The CEO of Ascentage Pharma, Yang Dajun, emphasizes the importance of targeting difficult drug targets and conducting rigorous clinical designs to achieve superior drug efficacy [4][6] Clinical Development - The Bcl-2 target is likened to PD-1 in blood cancer treatment, with the potential to treat various B-cell tumors effectively [5][6] - Lisatoclax has a unique dosing regimen that allows for a rapid escalation to the target dose, which is crucial for minimizing severe side effects like Tumor Lysis Syndrome (TLS) [6][7] - Clinical data suggest that Lisatoclax has a lower incidence of TLS compared to its competitors, enhancing its safety profile and making it a more convenient treatment option [6][7] Market Position and Strategy - Ascentage Pharma's stock has seen significant growth, with a year-to-date increase of over 70% in Hong Kong and more than 120% in the US market, indicating strong investor confidence [12] - The company aims to navigate the competitive landscape of innovative drugs by focusing on unique therapeutic targets rather than following trends in the market [12][13] - Yang Dajun believes that the current wave of innovation in the pharmaceutical industry is a result of accumulated experience, technological breakthroughs, and supportive policies [10][11] Future Outlook - Ascentage Pharma is optimistic about achieving profitability by 2027, reflecting its strategic focus on developing proprietary products that can generate revenue [13] - The company is positioned to capitalize on the evolving landscape of the biopharmaceutical industry, where the distinction between biotech and large pharmaceutical companies is increasingly defined by the ability to generate profits from self-developed products [13]