BEIJING--(BUSINESS WIRE)--Avistone Biotechnology Co. Ltd. (“Avistone” or “the Company”), an innovative biotechnology company focused on precision oncology therapeutics, announced that they received conditional approval from the National Medical Products Administration (NMPA) to commercialize Vebreltinib (also referred to as PLB1001, APL-101, Bozitinib, CBT-101) to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) in China.
The conditional approval was based on results from a pivotal Phase II KUNPENG study with an objective response rate (ORR) of 75.0% and median progression-free survival (PFS) in patients with advanced METex14 mutations to 14.1 months with a good safety profile as was recently presented at the 2023 European Society for Clinical Oncology (ESMO) Congress in Madrid, Spain (Poster# 1379P).
MET signaling is implicated in cell proliferation, migration, invasion, and survival. Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression. METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC.
"The development of drugs for indications related to MET targets has always been a difficult one. With the NMPA approval of Vebreltinib, we look forward to providing this new treatment option to patients with MET exon 14 skipping NSCLC in China” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone.
Avistone holds the exclusive rights to Vebreltinib in China, Hong Kong and Macau.
About Avistone Biotechnology Co. Ltd.
Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive pipeline of targeted therapies including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage. The Company’s lead asset is PLB1001, a small-molecule inhibitor that targets MET tyrosine kinase activity, including aberrant activity observed with METexon14 skipping (genetic) alterations in NSCLC tumors and in other solid tumors. The company's second clinical asset is PLB1004, a potent inhibitor of EGFR tyrosine kinases (TKI), including aberrant activity observed with EGFR exon20 insertion (genetic) mutations in NSCLC tumors.