Flumatinib Mesylate

引言 医药行业正迎来一场由人工智能技术驱动的深刻变革。作为中国领先的创新驱动型制药企业，翰森制药（HKEX：3692）正在积极拥抱这一趋势，通过多项AI合作与智能化布局，加速新药研发进程，提升生产效率，构建企业在数字化时代的新优势。 从与科技公司合作推进AI药物研发，到建设智能工厂实现生产数字化，翰森制药的AI动态反映了传统药企向创新驱动型企业的战略转型路径。 01 研发革新 AI驱动的小分子药物研发突破 翰森制药在AI药物研发领域的重要布局是与深势科技的合作。这次合作主要围绕深势科技的Hermite Uni-FEP自由能微扰计算模块展开，该技术能够以化学精度高效评估蛋白质与配体的结合自由能。 Hermite Uni-FEP界面 图源：动脉网新医药 Uni-FEP技术是当今公认精度最高、迁移性最好的亲和力评估计算方法。它通过将自由能微扰理论、分子动力学、增强采样算法与高性能计算相结合，可以实现工业规模的先导化合物优化筛选，显著提升药物研发效率。 与传统研发模式相比，这种“多尺度物理模型+AI+高性能计算”的新一代分子模拟技术，有望将过去以实验为主的试错式研发模式，转变为“计算设计-实验验证”的理性设计研发模式。 对于翰森制药而言，这种技术合作有助于解决医药行业研发周期长、药物设计复杂度高等共性痛点。AI技术的引入，为公司在蛋白结构预测、药物靶点发现、新药分子设计等关键环节提供了全新工具。 02 智能工厂 制药生产的数字化转型 翰森制药的智能化布局不仅限于研发环节，还扩展到了生产制造领域。2025年6月，翰森制药子公司江苏豪森药业和常州恒邦药业双双入选“江苏省先进级智能工厂”名单，体现了公司在生产环节智能化的成果。 江苏豪森药业的智能工厂项目构建了覆盖“研发-生产-供应链”的全流程数字化底座，采用“云-边-端”数据安全协同模式，融合5G、工业智能网关、数据采集分析等先进技术，全面提升全流程智能化水平。 在常州恒邦药业的抗体及抗体偶联药物（ADC）智能工厂项目中，公司按照FDA/EMA、cGMP认证标准，建立了针对靶向肿瘤细胞药物的自动化、智能化和个性化生物药制造中心。 这一智能工厂实现了高危作业100%自动化覆盖与重大安全事故归零的目标，显著提升了生产效率和工艺透明度。 智能工厂建设是翰森制药应对医药行业挑战的重要战略举措。通过大数据、云计算、物联网和AI算法等智能化技术手段，公司在工厂建设、研发设计、生产作业、质量管控等核心环节打造了多个智能制造典型场景。 03 业绩增长 创新药收入占比持续提升 翰森制药的AI布局与智能化转型并非孤立的技术尝试，而是与公司整体创新战略紧密相连。2025年上半年业绩数据显示，公司总营收达74.34亿元，同比增长14.3%，其中创新药与合作产品销售收入61.45亿元，占比82.7%，成为公司增长的主要动力。 2025H1，阿美替尼、氟马替尼等抗肿瘤领域产品组合实现收入45.31亿元；艾米替诺福韦片、吗啉硝唑等抗感染领域产品组合收入7.35亿元，同比增长4.9%；伊奈利珠单抗等中枢神经系统疾病领域产品组合收入7.68亿元，同比增长4.8%。 特别值得一提的是，代谢及其他疾病领域产品组合表现亮眼，实现收入约14亿元，同比增长高达134.5%。这一增长主要得益于公司在该领域的创新药布局和市场拓展。 在研发投入方面，翰森制药2025年上半年研发投入14.41亿元，占总营收的19.4%。公司目前拥有超40项候选创新药，公司正在开展70多项创新药临床试验，包括7个新I期临床试验和3个III期关键注册性临床试验。 04 行业背景 AI制药的合作与竞争态势 翰森制药的AI布局是在整个行业加速拥抱人工智能的大背景下展开的。当前，AI与制药领域的融合正在加速，2025年行业内已形成多起重要合作。 晶泰控股与DoveTree达成了470亿港元的管线合作，利用AI+机器人平台开发小分子及抗体类候选药物。云南沃森生物与上海智峪生物合作，应用AI建模技术加速疫苗研发。石药集团则与阿斯利康合作，利用AI引擎发现和开发新型口服小分子候选药物。 在资本层面，AI制药相关企业也受到青睐。熠旋生物近期完成数千万元的天使轮融资，专注于新型核酸药物的研发，凭借其独创的精准递送技术，成功突破传统药物治疗的局限。 这些行业动态表明，AI制药已从概念验证阶段逐步进入实际应用阶段。各大药企纷纷通过合作、投资或自建团队的方式布局AI技术，以应对药物研发成本高、周期长、成功率低等行业共性挑战。 05 战略展望 智能化转型的未来路径 展望未来，翰森制药的AI和智能化战略可能沿着三个维度深化推进：研发智能化、生产数字化和决策数据化。 在研发层面，公司可能会扩大AI技术在更多药物研发环节的应用。从目前的小分子化合物优化，逐步拓展到靶点发现、临床实验设计等更多环节。与深势科技的合作模式也可能被复制到其他技术领域，形成多元化的AI研发工具矩阵。 在生产层面，智能工厂的建设经验有望推广到更多生产基地。通过标准化、可复制的智能工厂解决方案，翰森制药可以加速实现生产体系的整体数字化升级，提升产品质量一致性和生产效率。 在决策层面，随着AI技术在研发和生产环节的深入应用，翰森制药将积累大量有价值的数据资源。通过对这些数据进行深度挖掘和分析，公司可以优化研发策略、生产计划和市场决策，形成数据驱动的创新闭环。 值得一提的是，翰森制药已开始尝试将AI技术应用于国际化战略。例如，公司的阿美替尼于2025年6月获得英国MHRA批准上市，成为翰森制药首个获准进入海外市场的创新药。AI技术可能在未来公司拓展国际市场的过程中发挥更大作用。 结语 随着医药行业竞争加剧，翰森制药的AI布局正在结出硕果。2025年上半年，公司创新药收入同比增长22.1%，在总收入中占比提升至82.7%。在AI助力下，公司有超过40项候选创新药正在开展70多项临床试验，研发管线持续丰富。 未来，随着AI技术与医药研发的进一步融合，翰森制药有望在精准医疗、个性化治疗方案等领域实现更多突破，为中国医药行业创新发展提供可借鉴的路径。 点赞推荐，将会推送更多AI制药信息给你哦～

ROCKVILLE, Md. and SUZHOU, China, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that the latest results from multiple clinical studies of its novel drug, olverembatinib (HQP1351), have been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year in which clinical data on olverembatinib have been selected by ASH for the Annual Meeting. This year, multiple clinical and preclinical studies on three of the company’s investigational drug candidates (olverembatinib, lisaftoclax and APG-5918) have been selected for presentations at the ASH Annual Meeting. Developed by Ascentage Pharma, olverembatinib is the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. At this year’s ASH Annual Meeting, Ascentage Pharma will release the first dataset from the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Moreover, 4-year follow-up data from a randomized controlled, registrational Phase II study of olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP); and updated data on olverembatinib in the second-line treatment of patients with non-T315I-mutant CML-CP are also set to be reported at the ASH Annual Meeting. The ASH Annual Meeting is one of the largest gatherings of the international hematology community, aggregating the latest scientific research on the pathogenesis and clinical treatment of hematologic diseases. The 67th ASH Annual Meeting will take place on December 6-9, 2025, local time, both online and in-person in Orlando, Florida. Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “For eight years in a row, clinical data on olverembatinib have been selected by the ASH Annual Meeting, an achievement reflecting the strong recognition of olverembatinib by the international hematology community. Olverembatinib is currently being evaluated in three global registrational Phase III studies. This year, multiple studies of our three key drug candidates have been selected for presentation at the ASH annual Meeting, underscoring Ascentage Pharma’s robust capabilities in global innovation and clinical development. We look forward to sharing more detailed data during the conference. Moving forward, we will continue to accelerate our clinical development programs in efforts to bring more treatment options to patients as soon as possible.” An overview of presentations featuring Ascentage Pharma’s drug candidates at ASH 2025: FormatDrug CandidateAbstract TitleAbstract#Oral PresentationLisaftoclax（APG-2575）Results of a registrational phase 2 study of lisaftoclax monotherapy for treatment of patients (pts) with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed Bruton’s tyrosine kinase inhibitors (BTKis)88Poster PresentationLisaftoclax（APG-2575）Results of the APG2575AU101 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients with newly diagnosed (ND) or prior venetoclax–exposed myeloid malignancies1641Olverembatinib（HQP1351）Results of POLARIS-1, a global phase 3 study (Part A): olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)1574Olverembatinib (HQP1351) demonstrates efficacy vs. best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) in a registrational randomized phase 2 trial: up to 4-year follow-up including patients without T315I mutations3788Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic phase-chronic myeloid leukemia (CP-CML)3782Preclinical and clinical Study of olverembatinib in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement1979Olverembatinib-mediated deep remission improves allogeneic stem cell transplantation outcome in patients with blast crisis chronic myeloid leukemia: First real-world practice report1999The efficacy and safety of switching to olverembatinib or continuing original TKI therapy in CML-CP patients treated with at least two prior TKIs: A prospective, multicenter, control trial3779Clinical and molecular features associated with glucolipid metabolic disorders and cardio-/cerebro-vascular adverse events in CML patients receiving olverembatinib therapy5561APG-5918Embryonic ectoderm development (EED) inhibitor APG-5918 overcomes immunomodulatory drug (IMiD) resistance as monotherapy and synergizes with IMiDs/cereblon E3 ligase modulators (CELMoDs) in preclinical models of multiple myeloma (MM)1528Abstract OnlyOlverembatinib（HQP1351）Single CAR-t infusion during front-line consolidation induces deep and sustained remission in newly diagnosed adult ph+b- ALL: A prospective phase 2 study442Lisaftoclax （APG-2575）BCL-2 inhibition in North American adult T-cell leukemia/lymphoma: Preclinical insights and early clinical outcomes3304 Major study abstracts on olverembatinib selected for presentations at the 2025 ASH Annual Meeting are as follows: (for details on the abstracts featuring lisaftoclax, please refer to a separate press release published at the same time) Results of POLARIS-1, a global Phase 3 study (Part A): olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)Format: Poster PresentationAbstract#: 1574Session: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster ITime: Saturday, December 6, 2025; 5:30 PM – 7:30 PM ESTFirst Author: Prof. Suning Chen, Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, ChinaPresenter: Prof. Suning Chen, Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, ChinaHighlights:This is a global registrational Phase III study (POLARIS-1; NCT06051409) designed to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with ND Ph+ ALL. The primary endpoint of the study was minimal residual disease (MRD; BCR-ABL/ABL1 ≤ 0.01% by qPCR) negativity rate by the end of three induction cycles. Efficacy Results: As of July 18, 2025, among 53 efficacy‑evaluable patients, 50 (94.3%) achieved a complete remission (CR) or CR with incomplete hematologic recovery by the end of induction therapy. The best MRD negativity and MRD-negative CR rates were 66.0% and 64.2%, respectively.IKZF1plus (particularly with concurrent BTG1 deletion) is a widely recognized high-risk factor in B-ALL as it can often cause resistance to chemotherapies and a high propensity to relapse. Among the 10 patients in this study who had this genotype, the molecular response rate at the end of the induction therapy was 90% (9/10). Safety Results: Olverembatinib in combination with low-dose chemotherapy was well tolerated. Common (incidence >15%) grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (63.6%), thrombocytopenia (56.4%), leukopenia (54.5%), anemia (49.1%), pneumonia (30.9%), hypokalemia (20%), and abnormal hepatic function (16.4%). Conclusion:In patients with ND Ph+ ALL, olverembatinib in combination with chemotherapy demonstrated an MRD-negative CR rate of 64.2% by the end of the induction therapy and a favorable safety profile. Olverembatinib (HQP1351) demonstrates efficacy vs. best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) in a registrational randomized phase 2 trial: up to 4-year follow-up including patients without T315I mutationsFormat: Poster PresentationAbstract#: 3788Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster IITime: Sunday, December 7, 2025; 06:00 PM - 08:00 PM ESTFirst Author: Prof. Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital, Beijing, ChinaPresenter: Prof. Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital, Beijing, ChinaHighlights: This is an open-label, randomized controlled, multicenter, pivotal registrational phase II study (NCT04126681) designed to evaluate the efficacy and safety of olverembatinib in patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. This report features an update on the results released in an oral presentation at ASH 2023. As of January 13, 2025, a total of 144 patients with CML-CP were enrolled in the study, including 105 patients without the T315I mutation.In this study, patients were randomized at a 2:1 ratio to the olverembatinib arm or the control arm with investigators’ choices of best available treatment (BAT). The primary endpoint is event-free survival (EFS). Efficacy Results: The olverembatinib arm achieved a significantly longer EFS than the BAT arm: among all patients with CML-CP, the median EFS of the olverembatinib arm and the BAT arm were 21.22 months and 2.86 months (P < 0.001), respectively. Among patients with CML-CP without the T315I mutation, the median EFS of the olverembatinib arm and the BAT arm were 11.96 months and 3.14 months (P = 0.0159), respectively.Other efficacy parameters of the olverembatinib arm were significantly better than those of the BAT arm: among all patients with CML-CP, complete hematologic response (CHR) rates of the olverembatinib arm and the BAT arm were 85% and 34.8%; the complete cytogenetic response (CCyR) rates were 37.5% and 18.9%; the major molecular response (MMR) rates were 29.5% and 8.1%, respectively. Among patients with CML-CP without the T315I mutation treated in the olverembatinib arm or the BAT arm, the CHR rates were 82.1% and 50.0%, the CCyR rates were 25.8% and 20.7%, the MMR rates were 16.1% and 10.3%, respectively. Safety Results: Both olverembatinib and BAT showed a favorable safety profile in patients with CML-CP with/without the T315I mutation. Major adverse event were hematologic toxicities. Conclusion: Olverembatinib demonstrated clear therapeutic advantage over the BAT arm in patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic phase-chronic myeloid leukemia (CP-CML)Format: Poster PresentationAbstract#: 3782Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster IITime: Sunday, December 7, 2025; 6:00 PM – 8:00 PM ESTFirst Author: Prof. Weiming Li, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaPresenter: Prof. Weiming Li, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaHighlights:This is an open-label, single-arm, multicenter clinical study (ChiCTR2200061655) designed to evaluate the efficacy and safety of orally administered olverembatinib at 40 mg every other day (QOD) in patients with CP-CML resistant/intolerant to one prior line of TKIs (including imatinib, flumatinib, nilotinib, and dasatinib) without the T315I mutation. As of July 24, 2025, the study has enrolled a total of 47 patients with CP-CML without the T315I mutation. Efficacy Results: As of July 24, 2025, 39 (83.0%) patients received at least one efficacy evaluation; 36 (76.6%) at least two efficacy evaluations; and 34 (72.3%) at least three efficacy evaluations. Two patients had not yet received their first efficacy evaluation.As of the data cut-off date, 71.8% (28/39) of patients achieved a CCyR and 43.6% (17/39) MMR. CCyR and MMR rates assessed at the end of cycles 6, 9, 12, 15, 18, 21, and 24 were 54.3% and 25.7%, 66.7% and 33.3%, 74.2% and 35.5%, 84.6% and 46.2%, 85.7% and 47.6%, 90.0% and 60.0%, and 89.5% and 57.9%, respectively, suggesting that responses deepened as treatment persisted.Among 39 efficacy-evaluable patients, 30 had received second-generation TKIs in first-line treatment. Of them, 76.7% (23/30) achieved a CCyR and 43.3% (13/30) MMR. Among the 9 patients who were pretreated with imatinib, 55.6% (5/9) achieved a CCyR and 44.4% (4/9) MMR. Safety Results: The median (range) treatment duration was 16.0 (1-18) cycles. A total of 42 (89.4%) patients experienced treatment-related adverse events (TRAEs) of any grade, including 21 (44.7%) patients who experienced grade ≥3 TRAEs and 6 (12.8%) patients who experienced serious adverse events (SAEs) related to olverembatinib. Grade ≥3 hematologic toxicities included platelet count decreased (42.6%), neutropenia (25.5%), and anemia (8.5%). Olverembatinib-related SAEs included platelet count decreased (6.4%) and anemia, myelosuppression, and pyrexia (2.1% each). No deaths were reported during the study. Conclusion: Olverembatinib may provide a safe and effective second-line treatment for patients with CP-CML, especially for those with disease that had failed on first-line treatment with second-generation TKIs. * Olverembatinib, lisaftoclax and APG-5918 are currently under investigation and have not yet been approved by the FDA in the US. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors. The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia ( AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the US FDA, the EMA of the EU, and China CDE. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/ Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestor Relations:Hogan Wan, Head of IR and StrategyAscentage PharmaHogan.Wan@ascentage.com+86 512 85557777 Stephanie CarringtonICR HealthcareAscentageIR@icrhealthcare.com+1 (646) 277-1282 Media Relations:Jon YuICR HealthcareAscentagePR@icrhealthcare.com+1 (646) 677-1855