GeneMedix GM-CSF approved in China

GeneMedix has received approval from the Chinese State DrugAdministration to market granulocyte macrophage colony-stimulating factor, under the brand name Neustim, as a treatment for neutropenia induced by chemotherapy associated with cancer, bone marrow transplants and AIDS-related disorders.

The drug will be available initially in a 150mcg pack, to be followed by 50mcg and 75mcg packs. The company anticipates that the supplementary regulatory approval for the two latter presentations and the price approval process will be completed within the next few months.

This approval and the launch of the company's first product onto the Chinese market is a chance for GeneMedix to break into the generic GM-CSF market, the size of which in China is estimated to be $25 million per year and increasing at a rate of 20% per annum.