SUZHOU, China, and ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that olverembatinib (R&D Code: HQP1351) has been included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management of  Chronic Myeloid Leukemia (CML),[1] marking a major development in global recognition for its best-in-class drug candidate, which has been approved in China for the management of tyrosine kinase inhibitor (TKI)-resistant patients with chronic- and accelerated-phase CML (CML-CP and CML-AP)..

中国苏州和马里兰州罗克维尔，2024年1月16日/PRNewswire/--Ascentage Pharma（6855.HK），一家全球生物制药公司，致力于开发治疗癌症、慢性乙型肝炎（CHB）和与年龄有关的疾病的新疗法，今天宣布，olverembatinib（研发代码：HQP1351）已被纳入国家综合癌症网络（NCCN）关于慢性粒细胞白血病（CML）管理的最新指南，标志着全球对其最佳候选药物的认可取得了重大进展，在中国已被批准用于治疗酪氨酸激酶抑制剂（TKI）耐药的慢性期和加速期CML（CML-CP和CML-AP）患者。。

NCCN is a not-for-profit organization allying 33 chiefly NCI-designated comprehensive cancer centers across the United States. Cancer management recommendations promulgated in the NCCN guidelines are continuously updated and downloaded more than 13 million times per year by practitioners and other key stakeholders. Serving as a standard for clinical practices in oncology in the US, the NCCN Guidelines is also one of the most widely adopted clinical guidelines for the global oncology community..

NCCN是一个非营利性组织，在美国各地联合了33个主要由NCI指定的综合癌症中心。NCCN指南中颁布的癌症管理建议每年由从业者和其他关键利益相关者不断更新和下载超过1300万次。作为美国肿瘤学临床实践的标准，NCCN指南也是全球肿瘤学界最广泛采用的临床指南之一。。

The NCCN guidelines report efficacy responses to olverembatinib in Chinese Phase I and II trials,[2] including major cytogenetic response (MCyR) rates of 79% and 47%, complete cytogenetic response (CCyR) rates of 69% and 47%, and major molecular response (MMR) rates of 56% and 45%, in patients with CML-CP and CML-AP, respectively..

NCCN指南报告了在中国I期和II期试验中对olverembatinib的疗效反应，包括CML-CP和CML-AP患者的主要细胞遗传学反应（MCyR）率分别为79%和47%，完全细胞遗传学反应（CCyR）率分别为69%和47%，主要分子反应（MMR）率分别为56%和45%。。

Clinical trials also suggest that olverembatinib has demonstrated effects regarding safety of the compound, with its common adverse events such as thrombocytopenia, hypertriglyceridemia, and chiefly asymptomatic elevation of enzymes that include creatine phosphokinase and liver transaminase, being typically grade 1-2 and manageable..

临床试验还表明，olverembatinib已证明对该化合物的安全性有影响，其常见的不良事件如血小板减少症，高甘油三酯血症，主要是包括肌酸磷酸激酶和肝转氨酶在内的酶的无症状升高，通常为1-2级且可控制。。

Findings reported at the 2023 American Society of Hematology (ASH) Annual Meeting continued to demonstrate that olverembatinib is well tolerated and effective in managing heavily TKI-pretreated CML, including in patients with challenging clinical profiles such as those with the T315I mutation who would otherwise have limited therapeutic options.

2023年美国血液学会（ASH）年会上报告的研究结果继续表明，olverembatinib耐受性良好，可有效治疗严重TKI预处理的CML，包括临床特征具有挑战性的患者，如T315I突变患者，否则治疗选择有限。

These studies showed that olverembatinib significantly prolonged the rigorous efficacy benchmark of event-free survival (EFS) and reduced clinical events by 60% compared to physicians' choices of best available therapies (BATs) in China (including imatinib, dasatinib, and nilotinib)[3]. Moreover, olverembatinib has shown encouraging clinical benefit in patients who have failed prior treatment with other targeted drugs, including the third-generation TKI ponatinib and the allosteric STAMP inhibitor asciminib.[4].

这些研究表明，与中国医生选择的最佳可用疗法（BATs）（包括伊马替尼，达沙替尼和尼罗替尼）相比，olverembatinib显着延长了无事件生存期（EFS）的严格疗效基准，并将临床事件减少了60%[3]。此外，olverembatinib在先前使用其他靶向药物（包括第三代TKI ponatinib和变构邮票抑制剂asciminib）治疗失败的患者中显示出令人鼓舞的临床益处。[4] 。

Olverembatinib is a novel, small-molecule, orally administered, third-generation BCR-ABL1 TKI initially approved in China in November 2021 for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harbouring the T315I mutation; and then in November 2023 for the treatment of adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs.

Olverembatinib是一种新型的小分子口服给药的第三代BCR-ABL1 TKI，最初于2021年11月在中国获得批准，用于治疗携带T315I突变的TKI耐药CML-CP或CML-AP的成年患者；然后在2023年11月用于治疗对第一代和第二代TKI耐药和/或不耐受的CML-CP成年患者。

Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics..

Olverembatinib正在由Ascentage Pharma和Innovent Biologics在中国联合商业化。。

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, remarked that, 'Inclusion in the prestigious NCCN guidelines marks another major milestone for olverembatinib. This event signals important recognition of our drug candidate by the oncology community. We are most encouraged that our cutting-edge, patient-centric innovation, which has culminated in a safe and effective treatment even in relapsed, refractory, and/or difficult-to-treat cases of CML, will bring meaningful improvement to patients' lives.

Ascentage Pharma董事长兼首席执行官杨大军博士表示，“纳入著名的NCCN指南标志着olverembatinib的另一个重要里程碑。这一事件标志着肿瘤学界对我们候选药物的重要认可。我们最受鼓舞的是，我们以患者为中心的尖端创新将为患者的生活带来有意义的改善，即使在复发，难治和/或难以治疗的CML病例中，这种创新也能安全有效地治疗。

Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will continue to investigate olverembatinib and accelerate our clinical development programs to benefit more patients.'.

我们将继续研究olverembatinib，并加速我们的临床开发计划，以使更多患者受益。

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, 'This recognition of olverembatinib as a potential CML treatment by the NCCN largely validates the impressive results on this drug candidate reported to date, including selection for Oral Presentation at the 2023 ASH Annual Meeting for the sixth consecutive year.

Ascentage Pharma首席医疗官翟一凡博士说，“NCCN对olverembatinib作为一种潜在的CML治疗方法的认可，在很大程度上验证了迄今为止报道的这种候选药物的令人印象深刻的结果，包括连续第六年在2023年ASH年会上选择口服。

Moving forward, we will expedite our clinical development programs to bring more safe and effective therapies to patients in need. These initiatives include our ongoing pivotal registrational Phase III trials of olverembatinib, including a study in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia [NCT06051409].'.

展望未来，我们将加快临床开发计划，为有需要的患者带来更安全有效的治疗方法。这些举措包括我们正在进行的olverembatinib关键注册III期试验，包括一项针对新诊断的费城染色体阳性急性淋巴细胞白血病患者的研究[NCT06051409]。

* Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland

*Olverembatinib是一种研究药物，尚未在中国大陆以外被批准用于任何适应症

References

参考文献

[1].  Shah N, Bhatia R, Altman JK et al.  NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Chronic Myeloid Leukemia Version 2.2024 (December 5, 2023). Available from: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed January 10, 2024.[2].  Jiang Q, Li Z, Qin Y et al.

[1] 。Shah N，Bhatia R，Altman JK等人，《NCCN肿瘤学临床实践指南》（NCCN Guidelines®）慢性粒细胞白血病2.2024版（2023年12月5日）。可从以下地址获得：https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf.2024年1月10日访问。[2]。江Q，李Z，秦Y等。

Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial. J Hematol Oncol 2022;15:113. [3].  Jiang Q, Li Z, Zhang G, et al. Olverembatinib (HQP1351) demonstrates efficacy vs.

Olverembatinib（HQP1351），一种耐受性良好且有效的酪氨酸激酶抑制剂，用于T315I突变的慢性粒细胞白血病患者：一项开放标签的多中心1/2期试验的结果。J Hematol Oncol 2022；15： 113.〔3〕。Jiang Q，Li Z，Zhang G等。Olverembatinib（HQP1351）证明了疗效与。

best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia chronic-phase (CML-CP) in a registrational randomized phase 2 study. Blood 2023;142(Suppl 1):869[4].  Jabbour E, Kantarjian H, Koller PB et al. Update of olverembatinib (HQP1351) overcoming ponatinib and/or Asciminib resistance in patients (pts) with heavily pretreated/refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

在一项注册随机2期研究中，酪氨酸激酶抑制剂（TKI）耐药慢性粒细胞白血病慢性期（CML-CP）患者（pts）的最佳可用治疗（BAT）。血液2023；142（补充1）：869[4]。Jabbour E，Kantarjian H，Koller PB等。olverembatinib（HQP1351）的更新克服了重度预处理/难治性慢性粒细胞白血病（CML）和费城染色体阳性急性淋巴细胞白血病（Ph+ALL）患者（pts）对ponatinib和/或Asciminib的耐药性。

Blood 2023;142 (Suppl 1):1798..

血液2023；142（增刊1）：1798。。

About Ascentage Pharma

关于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（6855。HK）是一家专注于全球的生物制药公司，致力于开发针对癌症，慢性乙型肝炎和与年龄有关的疾病的新型疗法。2019年10月28日，Ascentage Pharma在香港联合交易所主板上市，股票代码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专注于开发抑制蛋白质-蛋白质相互作用以恢复细胞凋亡或程序性细胞死亡的疗法。该公司已经建立了9种临床候选药物的管道，包括新型高效Bcl-2和双重Bcl-2/Bcl-xL抑制剂，以及针对IAP和MDM2-p53途径的候选药物，以及下一代酪氨酸激酶抑制剂（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 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..

Ascentage Pharma也是世界上唯一一家针对所有三类已知的关键凋亡调节剂开展积极临床计划的公司。该公司正在美国、澳大利亚、欧洲和中国进行40多项I/II期临床试验。Ascentage Pharma已被指定参与多项重大国家研发项目，包括五个重大新药项目、一个新药孵化器项目、四个创新药物项目和一个传染病防治重大项目。。

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 Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA).

Olverembatinib是该公司为治疗耐药性慢性粒细胞白血病（CML）而开发的核心候选药物，也是该公司首个获批产品，已被中国国家医药产品管理局（NMPA）药物评估中心（CDE）授予优先审查指定和突破性治疗指定。

To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib 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..

迄今为止，该药物已被纳入中国2022年国家报销药物清单（NRDL）。此外，olverembatinib已被美国FDA授予孤儿药名称（ODD）和快速通道名称（FTD），并被欧盟EMA授予孤儿名称。迄今为止，Ascentage Pharma已经从美国FDA获得了16个赔率，并从欧盟EMA获得了1个孤儿指定，用于该公司的4个研究候选药物。。

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.

凭借强大的研发能力，Ascentage Pharma建立了全球知识产权组合，并与众多知名生物技术和制药公司以及研究机构建立了全球合作伙伴关系，如UNITY biotechnology、MD Anderson癌症中心、Mayo Clinic、Dana Farber癌症研究所、MSD和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..

该公司建立了一支在创新药物的发现和开发方面具有全球经验的人才团队，并正在建立其世界一流的商业制造和销售与营销团队。Ascentage Pharma的一个关键目标是不断加强其研发能力，加速其临床开发计划，以实现其解决中国和世界各地未满足的临床需求的使命，造福更多患者。。

Forward-Looking Statements

前瞻性声明

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.

本文所作的前瞻性陈述仅与截至本文所作陈述之日的事件或信息有关。除法律要求外，Ascentage Pharma没有义务在声明发布之日后，由于新信息、未来事件或其他原因，或为了反映意外事件的发生，公开更新或修改任何前瞻性声明。

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.

您应该完整阅读本文，并了解我们未来的实际结果或表现可能与我们预期的有实质性差异。在本文中，我们或我们的任何董事或我们公司的意图的陈述或引用是在本文日期做出的。

Any of these intentions may alter in light of future development..

这些意图中的任何一个都可能根据未来的发展而改变。。

SOURCE Ascentage Pharma

来源：Ascentage Pharma