Apollomics Inc. (Nasdaq: APLM) has announced a significant development regarding vebreltinib (APL-101) in China. The National Medical Products Administration (NMPA) has granted approval to Avistone Biotechnology Co. Ltd., Apollomics' partner, for the use of vebreltinib in treating adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma who have the PTPRZ1-MET fusion (ZM fusion) gene and have previously failed treatments.This approval marks vebreltinib as the first c-Met inhibitor globally approved for treating Central Nervous System (CNS) tumors with c-Met alterations.

Apollomics Inc.（纳斯达克股票代码：APLM）宣布，维布替尼（APL-101）在中国取得了重大进展。美国国家医疗产品管理局（NMPA）已批准阿波罗公司的合作伙伴Avistone Biotechnology Co.Ltd.使用维布雷替尼治疗患有异柠檬酸脱氢酶（IDH）突变型星形细胞瘤（WHO 4级）或胶质母细胞瘤的成年患者，这些患者具有PTPRZ1-MET融合（ZM融合）基因，并且以前的治疗失败。该批准标志着vebreltinib是全球首个被批准用于治疗具有c-Met改变的中枢神经系统（CNS）肿瘤的c-Met抑制剂。

Previously, the NMPA approved vebreltinib in November 2023 for treating patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).Apollomics, emphasized the significance of this approval, highlighting vebreltinib's penetration into the CNS and its inhibitory activity against c-Met in tumors.

此前，NMPA于2023年11月批准vebreltinib用于治疗Met外显子14跳过非小细胞肺癌（NSCLC）的患者。Apollomics强调了这一批准的重要性，强调了vebreltinib对中枢神经系统的渗透及其对肿瘤中c-Met的抑制活性。

He also stressed the collaboration with Avistone and the ongoing global SPARTA trial as evidence of their commitment to developing vebreltinib for patients globally with solid tumors harboring c-Met alterations.Gliomas present significant treatment challenges, constituting a considerable portion of intracranial tumors.

他还强调了与Avistone的合作以及正在进行的全球SPARTA试验，作为他们致力于为全球患有c-Met改变的实体瘤患者开发vebreltinib的证据。神经胶质瘤提出了重大的治疗挑战，构成了颅内肿瘤的相当一部分。

Current standard treatments offer limited success, with poor prognoses and low overall survival rates. Notably, about 12% of gliomas in Chinese patients exhibit MET fusion, with the ZM fusion being a common subtype associated with a poorer prognosis.Vebreltinib, Apollomics' leading product candidate in the U.S., is a potent, orally bioavailable c-Met inhibitor.

目前的标准治疗效果有限，预后差，总生存率低。值得注意的是，中国患者中约12%的神经胶质瘤表现出MET融合，ZM融合是一种常见的亚型，预后较差。Vebreltinib是Apollomics在美国的主要候选产品，是一种有效的口服生物可利用的c-Met抑制剂。

It works by disrupting the aberrant activation of the HGF/c-Met axis, a pivotal pathway in tumor growth and resistance to targeted therapies.The approval in China was based on positive resul.

它通过破坏HGF/c-Met轴的异常激活而起作用，HGF/c-Met轴是肿瘤生长和靶向治疗抵抗的关键途径。中国的批准是基于积极的结果。