On November 16, 2023, the National Medical Products Administration (NMPA) released an announcement approving Vebreltinib Enteric-Coated Capsules (trade name: Wanbirui, vebreltinib), a Class 1 innovative drug independently developed by Beijing Purion Pharma Co., Ltd., a wholly-owned subsidiary of Beijing Anshi Biotech Co., Ltd. The drug is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations.
Previously, vebreltinib had been designated as a Breakthrough Therapy by the NMPA in February 2021 and included in the Priority Review and Approval Procedure in September 2022, thanks to its superior efficacy and safety profile.
· NSCLC with MET Exon 14 Skipping Mutation Features a Poor Prognosis and Severe Threat to Patients’ Health, Urgently Calling for Better Treatment Options
About Lung Cancer
Lung cancer is the most prevalent cancer in China, ranking first in both incidence and mortality among all malignant tumors. Previous studies have shown that patients with MET exon 14 skipping mutations are predominantly elderly (median age: 72.5 years) and have a high risk of brain metastasis (20%–40%)¹. MET exon 14 skipping mutations are generally associated with high tumor invasiveness, resistance to antineoplastic therapies and dismal prognosis, and patients with this alteration respond poorly to chemotherapy and immunotherapy.
Research on Vebreltinib
Vebreltinib is a highly selective c-MET inhibitor independently developed in China with outstanding inhibitory activity. It was granted Breakthrough Therapy designation based on the Phase I clinical trial results presented at the 2020 Annual Meeting of the American Association for Cancer Research (AACR).
The KUNPENG study is an open-label, multicenter, single-arm Phase II registrational clinical trial led by Professor Wu Yilong from Guangdong Provincial People's Hospital. As of August 2022, the study enrolled a total of 113 patients, among whom 52 had MET exon 14 skipping mutations.
Summary
As a domestically developed MET inhibitor in China, vebreltinib has demonstrated remarkable antitumor activity and favorable tolerability in treating NSCLC patients with MET exon 14 skipping mutations. The recent approval of vebreltinib will enable more such patients to benefit from precision targeted therapy, bringing new survival hope to them. In the future, vebreltinib will continue to be explored for the management of tumors with MET gene abnormalities, aiming to achieve more therapeutic breakthroughs for patients with MET-mutated tumors.
About Wanbirui
Wanbirui (vebreltinib) is a small-molecule, highly selective MET inhibitor. It exerts potent tumor-inhibitory effects in multiple preclinical models, including cell line-derived xenograft (CDX) models of human gastric, hepatic, pancreatic and lung cancers with MET abnormalities, as well as patient-derived xenograft (PDX) mouse models. To date, eight clinical trials of this drug have been registered in China, covering indications such as NSCLC and glioma.
In February 2021, vebreltinib was designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) of the NMPA for the treatment of NSCLC with MET exon 14 skipping mutations. On September 14, 2022, it was included in the CDE’s Priority Review list. In August 2022, vebreltinib was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).
