Apollomics Inc’s APLM partner in China, Avistone Biotechnology Co. Ltd., has 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).
In active pursuit of the MET exon 14 skipping NSCLC indication, Apollomics is engaged in discussions with the FDA regarding a New Drug Application (NDA) for vebreltinib, drawing on the totality of clinical data from the global SPARTA trial and Avistone’s KUNPENG trial in China.
NSCLC accounts for about 85% of all lung cancer cases and remains a top cause of cancer-related deaths globally.
Patients with MET exon 14 skipping mutations comprise about 3% to 4% of all NSCLC cases.
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.
Price Action: APLM shares have surged by 44.8% to $1.26 on the last check Thursday.