Avistone Biotechnology receives NMPA approval for Vebreltinib in China

Avistone Biotechnology Co. Ltd., a precision oncology therapeutics company, has announced the conditional approval from the National Medical Products Administration (NMPA) of China for commercializing Vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).

Pivotal Phase II Study Results Underpinning Approval

The NMPA’s decision was influenced by the positive outcomes of the pivotal Phase II KUNPENG study. The study showcased an objective response rate (ORR) of 75.0% and a median progression-free survival (PFS) of 14.1 months in patients with advanced METex14 mutations, along with a favorable safety profile, as presented at the 2023 European Society for Clinical Oncology (ESMO) Congress in Madrid.

Significance of MET Signaling in NSCLC

MET signaling plays a crucial role in cellular functions such as proliferation, migration, and survival. Alterations in MET, including MET exon 14 skipping, can drive oncogenesis in NSCLC. METex14 is notably associated with poorer survival rates in NSCLC patients.

China’s NMPA Conditionally Approves Avistone’s NSCLC Treatment, Vebreltinib

Avistone’s Commitment to MET-Targeted Therapeutics

Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone, emphasized the challenges in developing drugs targeting MET alterations. With the approval of Vebreltinib, Avistone aims to offer a new treatment option for patients with MET exon 14 skipping NSCLC in China.

Exclusive Rights to Vebreltinib in Greater China

Avistone holds exclusive rights to Vebreltinib in China, including Hong Kong and Macau, positioning them as a key player in the region’s precision oncology landscape.