Apollomics announces first approval of vebreltinib for MET Exon 14 skip NSCLC

Apollomics announced that its partner in China, Avistone Biotechnology, received conditional approval from the National Medical Products Administration, NMPA, of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer, NSCLC. “The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China. Apollomics extends its full support and congratulations to Avistone on this significant achievement,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “Our collaboration with Avistone and our ongoing global SPARTA trial with vebreltinib underscores our dedication to developing novel therapies for difficult to treat cancers and drug resistant patients worldwide.” In pursuit of the MET exon 14 skipping NSCLC indication, Apollomics is in active discussion with the U.S. Food and Drug Administration regarding a New Drug Application for vebreltinib based on totality of clinical data from the global SPARTA trial and Avistone’s KUNPENG trial in China. Under the partnership agreement, Avistone holds the exclusive rights to vebreltinib in China, Hong Kong and Macau, while Apollomics retains the exclusive rights in the rest of the world, including the U.S, and partners have access to each other’s data. This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.