BEIJING--(BUSINESS WIRE)--Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced the approval to expand the use of vebreltinib (also referred to as PLB1001, APL-101, bozitinib, CBT-101) from the Chinese National Medical Products Administration (NMPA) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant Astrocytoma (World Health Organization grade 4) with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments.

北京——（商业新闻短讯）——专注于精准肿瘤治疗的创新性生物技术公司北京爱维斯通生物技术有限公司（也称为爱维斯通生物技术或爱维斯通）宣布，批准扩大使用中国国家医药产品管理局（NMPA）的维布雷替尼（也称为PLB1001，APL-101，bozitinib，CBT-101），用于治疗具有PTPRZ1-MET融合基因的异柠檬酸脱氢酶（IDH）突变型星形细胞瘤（世界卫生组织4级）或具有PTPRZ1-MET融合（ZM融合）的低度疾病史的成胶质细胞瘤的成年患者）基因，并且以前的治疗失败了。

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration. In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA..

这项补充新药申请（sNDA）批准使vebreltinib成为世界上第一种被批准用于治疗c-Met改变的中枢神经系统（CNS）肿瘤的c-Met抑制剂。2023年11月，vebreltinib获得了有条件的批准，用于治疗转移性患者，MET外显子14跳过了NMPA的非小细胞肺癌（NSCLC）。。

Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1]. Surgery, radiotherapy and chemotherapy are current standard treatment strategies for gliomas, and the prognosis is poor. The 5-year overall survival (OS) rate of patients with malignant glioma is less than 10% [2].

胶质瘤是一种难治性原发性恶性颅内肿瘤，约占颅内肿瘤的46%[1]。手术、放疗和化疗是目前胶质瘤的标准治疗策略，预后较差。恶性胶质瘤患者的5年总生存率（OS）低于10%[2]。

In previous studies in Chinese patients, about 12% of brain gliomas were found to have MET fusion [3]. Among the representative type PTPRZ1-MET fusion gene (hereinafter referred to as ZM fusion) occurs in about 14% of glioblastomas with a history of lower-grade disease, often co-occurring with MET Exon 14 skipping mutations and is associated with poor prognosis [3-4]..

在之前对中国患者的研究中，约12%的脑胶质瘤被发现有MET融合（3）。在代表性的PTPRZ1-MET融合基因（以下简称ZM融合）中，约有14%的胶质母细胞瘤有低度疾病史，常与MET外显子14跳跃突变同时发生，并与预后不良有关[3-4]。。

The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619). The FUGEN study is a randomized controlled, open label, multicenter clinical registration phase II/III study. This 84-patient study compared the efficacy and safety of vebreltinib with the dose-dense regimen of temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint.

vebreltinib对ZM融合阳性胶质瘤适应症的批准是基于FUGEN研究（NCT06105619）的阳性结果。FUGEN研究是一项随机对照，开放标签，多中心临床注册II/III期研究。这项84名患者的研究比较了vebreltinib与替莫唑胺剂量密集方案或依托泊苷与顺铂联合治疗的疗效和安全性，OS为主要终点。

The median OS for the vebreltinib monotherapy regimen was 6.31 months, compared to 3.38 months for the control group, reducing the risk of death by 48% and significantly improving the survival of patients with recurrent relapsing ZM fusion glioma, with an acceptable safety profile..

vebreltinib单药治疗方案的中位OS为6.31个月，而对照组为3.38个月，将死亡风险降低48%，并显着提高复发性ZM融合胶质瘤患者的生存率，具有可接受的安全性。。

'The development of drugs for indications related to MET targets has always been a difficult one. This is not only a victory for translational medicine, but also marks the advent of the era of targeted therapy in the field of brain glioma,” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone..

“开发与达到目标相关的适应症药物一直是一项艰巨的任务。这不仅是转化医学的胜利，而且标志着脑胶质瘤领域靶向治疗时代的到来，”Avistone董事长、首席执行官兼创始人石和鹏博士说。。

About Avistone Biotechnology

关于Avistone Biotechnology

Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors..

北京艾维斯通生物技术有限公司（也称为艾维斯通生物技术或艾维斯通）是一家创新型生物技术公司，专注于为全球医疗需求严重未得到满足的患者开发创新疗法。Avistone在非小细胞肺癌（NSCLC）和其他实体瘤中拥有广泛的靶向治疗组合和管道。。

References:

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