美国和欧盟监管机构批准了对新确诊的Ph+所有病人的OLVEREMBABTINIB进行全球第三阶段试验,并取得了有希望的早期结果。 U.S. and EU regulators approved a global Phase III trial for olverembatinib in newly diagnosed Ph+ ALL patients, with promising early results.

美国FDA和欧洲药物管理局已批准Acentcentcent Pharma启动全球III期试验 (POLARIS-1),对新诊断的费城染色体阳性急性淋巴细胞白血病 (Ph+ ALL) 患者进行奥尔维伦巴替尼和化疗的试验. The U.S. FDA and European Medicines Agency have approved Ascentage Pharma to launch a global Phase III trial (POLARIS-1) testing olverembatinib plus chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients. 该试验已经在中国和其他地区进行,目的是评估药物作为一线治疗的功效和安全性。 The trial, already active in China and other regions, aims to evaluate the drug’s efficacy and safety as a first-line treatment. 2025年ASH会议早期数据显示,在三个周期后,特别是在高风险子类型中,最低程度的残余疾病消极率很高。 Early data from the 2025 ASH meeting showed high rates of minimal residual disease negativity after three cycles, especially in high-risk subtypes. Olverembatinib已被中国批准用于抗抗氯乙烯单体,现已获得 " 突破治疗 " 指认,并被列入国家准则。 Olverembatinib, already approved in China for resistant CML, has received Breakthrough Therapy Designation and is included in national guidelines. 与武田签订的协定可能导致在中国、香港、澳门和台湾以外实现全球权利。 An agreement with Takeda may lead to global rights outside China, Hong Kong, Macau, and Taiwan. 毒品在美国仍在调查中,尚未获得批准。 The drug remains investigational in the U.S. and not yet approved.