US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer (NSCLC), with these mutations representing approximately 3%-4% of all NSCLC cases worldwide.
Global Impact and Ongoing Discussions with US FDA
This approval in China marks the molecule’s first global approval. Apollomics, which has operations in California, US, and Hangzhou, China, is currently in discussions with the US FDA for an NDA filing for vebreltinib. This filing will be based on a combination of clinical data from the global SPARTA trial and Avistone’s KUNPENG trial in China.
Avistone’s Background and Rights to Vebreltinib
Avistone, which was established in 2021 with USD 200 million in backing from Bain Capital and Primavera Capital, merged with Beijing-based Pearl Biotechnology Co., Ltd shortly after its emergence. The company now controls the development of vebreltinib and holds exclusive rights to the drug in China, Hong Kong, and Macau. Avistone collaborates with and shares data with Apollomics.- Flcube.com
