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 the China National Medical Products Administration (NMPA) has approved olverembatinib (HQP1351) for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs).

Ascentage Pharma（6855.HK）是一家全球生物制药公司，致力于开发癌症，慢性乙型肝炎（CHB）的新疗法，今天宣布，中国国家医药产品监督管理局（NMPA）批准olverembatinib（HQP1351）用于治疗慢性期慢性粒细胞白血病（CML-CP）耐药和/或不耐受第一和第二代酪氨酸激酶抑制剂（TKIs）。

This approval, marking yet another major milestone for olverembatinib following its first regulatory approval in 2021 and the subsequent inclusion into the China 2022 National Reimbursement Drug List (NRDL), which will benefit a broader population of patients with CML in China.This approval for olverembatinib is based on the results from an open-label, national multicenter, randomized-controlled, registrational pivotal Phase II study (HQP1351CC203) that evaluated the efficacy and safety of olverembatinib in patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs.

这项批准标志着olverembatinib在2021年首次获得监管部门批准并随后纳入中国2022年国家报销药物清单（NRDL），这将有利于中国更多的CML患者。olverembatinib的批准基于开放标签，国家多中心，随机对照，注册关键II期研究（HQP1351CC203）的结果，该研究评估了olverembatinib对CML-CP耐药和/或不耐受的患者的疗效和安全性。第一代和第二代TKI。

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT). Results from the study show that compared to patients who were treated with the BAT in the control group, those received olverembatinib achieved statistically significant improvement in the primary endpoint of event-free survival (EFS),meeting the primary endpoint of the study.

患者随机接受olverembatinib或进入对照组接受目前最佳可用治疗（BAT）。研究结果显示，与对照组接受BAT治疗的患者相比，接受olverembatinib治疗的患者在无事件生存期（EFS）的主要终点获得统计学显着改善，达到研究的主要终点。

In March 2021, the Center of Drug Evaluation (CDE) of the NMPA granted olverembatinib a Breakthrough Therapy Designation (BTD) to olverembatinib; and in July 2022, the New Drug Application (NDA) for olverembatinib in this indication was accepted and granted a Priority Review Designation by the CDE.CML is a hemato.

2021年3月，NMPA药物评估中心（CDE）授予olverembatinib突破性治疗名称（BTD）至olverembatinib；并于2022年7月接受了本适应症中olverembatinib的新药申请（NDA），并获得了CDE的优先审查指定。CML是一种血液。