The Chinese National Medical Products Administration (NMPA) has granted conditional approval to Apollomics’ partner Avistone Biotechnology to commercialise vebreltinib (APL-101) in China for 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, Chairman and Chief Executive Officer of Apollomics.
Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. It works by inhibiting the aberrant activation of the HGF/c-Met axis, a key pathway involved in tumour growth, proliferation, and the development of resistance to certain targeted therapies.
Patients with MET exon 14 skipping mutations comprise approximately 3-4% of all NSCLC cases, and face significant challenges due to limited treatment options.
The SPARTA clinical trial
Apollomics is conducting a multi-cohort Phase II study of vebreltinib, SPARTA, at over 90 centres in 13 countries investigating the efficacy and safety of vebreltinib in MET exon 14 skipping non-small cell lung cancer (NSCLC).
Apollomics is in active discussion with the US Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for vebreltinib based on clinical data from the 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 US, and partners have access to each other’s data.