BeiGene Ltd. said the China National Medical Products Administration accepted its supplemental import drug application for a combination of Abraxane and chemotherapy to treat a certain pancreatic cancer.
The Beijing-based company is seeking the Chinese health regulator's approval for the expanded use of Abraxane and chemotherapy drug gemcitabine, marketed as Gemzar, among others, as the first-line treatment of pancreatic cancer that has spread to other parts of the body.
Abraxane is already approved to treat patients with breast cancer that has spread across the body in China. The drug is being marketed by BeiGene in China through an exclusive license from Celgene Corp.
The U.S. Food and Drug Administration approved Abraxane plus gemcitabine, for the same pancreatic cancer indication, in September 2013.