Apollomics Inc's APLM partner in China, Avistone Biotechnology Co. Ltd., 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 pursuit of the MET exon 14 skipping NSCLC indication, Apollomics is in active discussion with the FDA regarding a New Drug Application (NDA) for vebreltinib based on the totality of clinical data from the global SPARTA trial and Avistone's KUNPENG trial in China.
NSCLC accounts for approximately 85% of all lung cancer cases and remains a leading cause of cancer-related deaths worldwide.
Patients with MET exon 14 skipping mutations comprise approximately 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 are up 44.8% at $1.26 on the last check Thursday.
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