c-Kit x Bcr-Abl T315I

ROCKVILLE, Md. and SUZHOU, China, July 3, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first-in-class and best-in-class therapies for hematological malignancies, announced today that on July 2, 2024, in relation to the Exclusive Option Agreement with Takeda for the third-generation BCR-ABL inhibitor olverembatinib (HQP1351), Ascentage Pharma has received the US$100 million option payment called for by the Exclusive Option Agreement. On June 14, 2024, Ascentage Pharma and Takeda entered into an Exclusive Option Agreement that granted Takeda an exclusive option to enter into an exclusive license agreement for olverembatinib. The Exclusive Option Agreement calls for Ascentage Pharma to receive an option payment of US$100 million and provides for Ascentage Pharma to be eligible for an option exercise fee and additional potential milestone payments of up to approximately US$1.2 billion and double-digit royalties on annual sales. About Ascentage Pharma Ascentage Pharma (6855.HK) is a fully integrated global biopharmaceutical company engaged in discovering, developing and commercializing both first-in-class and best-in-class therapies to address global unmet medical needs primarily in hematological malignancies. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma has built a pipeline of 9 clinical-stage drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 clinical trials, including 6 global registrational Phase III studies, in the US, Australia, Europe, and China. Olverembatinib, the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development. SOURCE Ascentage Pharma

亚盛医药宣布，其原创1类新药奥雷巴替尼（商品名：耐立克®）获国家药品监督管理局（NMPA）药品审评中心（CDE）公示，被纳入“拟突破性治疗品种”公示名单，治疗既往经过一线治疗的琥珀酸脱氢酶（succinate dehydrogenase, SDH）缺陷型胃肠道间质瘤（GIST）患者。 这是奥雷巴替尼第二次获CDE纳入突破性治疗品种。2021年3月，该品种首次获纳入突破性治疗品种，用于治疗一代和二代酪氨酸激酶抑制剂（TKI）耐药和/或不耐受的慢性期慢性髓性白血病（CML-CP）患者。该适应症的上市申请于2022年7月获NMPA受理并被纳入优先审评程序，将支持奥雷巴替尼获得完全批准。目前，奥雷巴替尼已获得两项CDE授予的优先审评资格，呈现明显的临床价值与优势。 突破性治疗品种通常被授予用于防治严重危及生命或者严重影响生存质量的疾病、且尚无有效防治手段或者与现有治疗手段相比有足够证据表明具有明显临床优势的创新药或者改良型新药等。对于被纳入突破性治疗品种的药物，CDE将优先配置资源进行沟通交流，加强指导并促进药物研发进程；申请人经评估符合相关条件的，也可以在申请产品上市许可时提出附条件批准申请和优先审评审批申请。总之，突破性治疗品种的审评政策将加快具有重大临床价值、临床急需的创新药或者改良型新药的开发与上市。 GIST是一种起源于胃肠道间叶组织的肿瘤，大部分的GIST患者伴有KIT或PDGFRA基因突变。TKI的出现，改善了这类GIST患者的预后。然而，在SDH缺陷型GIST这一罕见的亚型GIST治疗领域，却存在巨大的、未被满足的临床需求。据悉，SDH缺陷型GIST患者通常对现有的TKI药物不敏感，虽然早期的局限性患者可通过手术治疗，但大部分患者仍然会复发。目前尚无针对复发和晚期SDH缺陷型GIST患者的标准治疗方案，5年无事件生存率（EFS）仅为24%。 奥雷巴替尼是亚盛医药原创1类新药，是中国首个且唯一获批上市的第三代BCR-ABL抑制剂，用于治疗任何TKI耐药、并伴有T315I突变的CML-CP或加速期CML（CML-AP）的成年患者。奥雷巴替尼在中国的商业化推广由亚盛医药和信达生物共同负责。而在血液肿瘤领域的临床开发与应用之外，奥雷巴替尼在多个临床前GIST模型中呈现了抗肿瘤活性，并得到临床数据的初步验证。值得一提的是，该品种在SDH缺陷型GIST患者中呈现出令人振奋的抗肿瘤活性。一项在中国进行的1b/2期研究最新数据显示，奥雷巴替尼在SDH缺陷型GIST患者中的临床获益率（CBR）高达93.8%，该临床研究也因此连续两年入选美国临床肿瘤学会（ASCO）年会展示。 亚盛医药首席医学官翟一帆博士表示：“十分感谢相关政府部门对耐立克®临床价值的认可！此次耐立克®拟获纳入突破性治疗品种，显示其在SDH缺陷型GIST领域具有重大的临床潜力和价值，也是该药物开发过程中在血液肿瘤之外的又一个重要里程碑。我们将继续与CDE保持紧密沟通，以期进一步加速相关适应症在中国的开发速度，早日惠及患者。” 内容来源于网络，如有侵权，请联系删除。

SUZHOU, China and ROCKVILLE, Md., March 14, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the latest results from three preclinical studies of the company's novel third-generation BCR-ABL inhibitor olverembatinib (HQP1351) and two key assets of Ascentage Pharma's apoptosis-targeting pipeline, the Bcl-2 inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115), have been selected for presentations at the 2023 American Association of Cancer Research Annual Meeting (AACR 2023). These results provide key findings that will support continued advances in the development of innovative therapeutics. Abstracts featuring these results have already been published in the AACR's official website. The AACR annual meeting is one of the world's largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year's AACR annual meeting will be held from April 14-19, 2023, in Orlando, Florida, USA. These three abstracts from Ascentage Pharma include: Olverembatinib (HQP1351) Olverembatinib (HQP1351) enhances antitumor effects of immunotherapy in renal cell carcinoma (RCC) Abstract#: 5071 Track: Immunology Session Title: Combination Immunotherapies 1 Session Time: Tuesday, April 18, 2023, 1:30 PM-5:00 PM, EDT Our results suggest that combining olverembatinib with a checkpoint inhibitor (CPI) confers synergistic antitumor effects in an RCC cancer mouse model by targeting tumor growth, angiogenesis, and immune regulation. This novel combination may provide an alternative approach to enhance treatment effects with CPIs in renal cancers. Olverembatinib (HQP1351) plus Lisaftoclax (APG-2575) Combination of olverembatinib (HQP1351) with BCL-2 inhibitor lisaftoclax (APG-2575) overcomes resistance in gastrointestinal stromal tumors (GISTs) Abstract#: 1631 Track: Experimental and Molecular Therapeutics Session Title: Novel Antitumor Agents 3 Session Time: Monday, April 17, 2023, 9:00 AM-12:30 PM, EDT Our results demonstrate that olverembatinib and Bcl-2 inhibitor lisaftoclax have synergistic antitumor effects in imatinib-resistant GIST. Considering that the resistance mechanisms are similar for most tyrosine kinase inhibitors (TKIs), this novel dual approach may have the potential for treating patients with GISTs whose disease has progressed after treatment with imatinib or other TKIs. Alrizomadlin (APG-115) MDM2 inhibitor alrizomadlin (APG-115) promotes antitumor activity of mitogen-activated protein kinase (MAPK) inhibitors in uveal melanoma Abstract#: 1632 Track: Experimental and Molecular Therapeutics Session Title: Novel Antitumor Agents 3 Session Time: Monday, April 17, 2023, 9:00 AM-12:30 PM, EDT Our results demonstrate the potential utility of combining alrizomadlin with MAPK pathway inhibitors to treat patients with uveal melanoma. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 50 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review designations and a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). Furthermore, it has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. SOURCE Ascentage Pharma