On June 30, 2025, vebreltinib enteric-coated capsules (brand name: Wanbirui, vebreltinib), a MET inhibitor independently developed by Beijing Purinno Biotech Co., Ltd. (Purinno Biotech), a wholly-owned subsidiary of Beijing AnsMed Biopharma Co., Ltd. (AnsMed Biopharma), was granted conditional approval by the National Medical Products Administration (NMPA) of China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) amplification. This marks the third indication of vebreltinib approved in China and the world’s first approved monotherapy indication for MET-amplified NSCLC, ushering MET-amplified NSCLC into the era of precision targeted therapy.
The approval of vebreltinib for this indication in China is based on positive results from Cohort 2 and Cohort 3 of the KUNPENG study (NCT04258033). The KUNPENG study is a multicenter, multi-cohort, open-label phase II registrational clinical trial evaluating the efficacy and safety of vebreltinib in patients with advanced NSCLC harboring MET aberrations. Cohort 2 primarily enrolled pretreated patients with MET amplification who had failed standard-of-care treatment (platinum-based chemotherapy); Cohort 3 mainly enrolled treatment-naïve patients with MET amplification who refused chemotherapy.
About MET Amplification
In NSCLC, MET aberrations include MET exon 14 skipping mutations, MET gene amplification, MET point mutations, MET gene fusions, and MET protein overexpression, among others³. The incidence and clinical significance of different types of MET aberrations vary, requiring precise identification. As one of the driver genes in NSCLC, MET gene amplification has an incidence of 1%–5% and serves as a well-defined biomarker for targeted therapy. Currently, there are no standardized treatment recommendations for MET-amplified NSCLC in China; clinical practice mostly adopts regimens for driver gene-negative NSCLC, which deliver suboptimal efficacy and fail to meet clinical needs.
About Vebreltinib
Wanbirui (vebreltinib) enteric-coated capsules received conditional approval in China in November 2023 for the treatment of patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. In April 2024, the drug was approved for adult patients with IDH-mutant astrocytoma (WHO grade 4) or glioblastoma with a history of lower-grade disease harboring the PTPRZ1-MET fusion gene who had failed prior therapy.
On December 25, 2024, AnsMed Biopharma submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of the NMPA for vebreltinib intended for the treatment of patients with locally advanced or metastatic NSCLC with MET amplification. The NDA was officially accepted and granted priority review status.
