Recently, the company independent research and development of biological products class 1 new drug - "injection with recombinant carboxypeptidase G2", has now been submitted to the food and drug administration clinical application, the new drug in mid-april smooth completion of the inspection work. On May 13, the variety has won the state food and drug administration and drug review center to accept the notice.
Glucarpidase (carboxypeptidase) trade name Voraxaze valley (card), the first by a British pharmaceutical company BTG company research and development, the reducing of kidney damage caused by chemotherapy drugs methotrexate (MTX) clearance levels of poisoning after prolonged. Voraxaze (valley card horse enzymes) in September 2011 by the FDA granted orphan drug status, and in January 2012, the FDA approved, by BTG company sales in the us market, and have 7 years of market monopoly.
Carboxypeptidase G2 (carboxypeptidase G2, CPG2) is a kind of carboxypeptidase, can specifically applies to the free carboxyl terminal for glutamate MTX, MTX enzyme solution for non-toxic metabolites 4 - DNA - amino - N10-4 - methyl butterfly (DAMPA) and glutamic acid, which provides an alternative to the kidneys to MTX, quickly reduce blood levels of MTX. CPG2 relative molecular mass of 83000, through the cell membrane, enzyme solution only a large amount of free MTX in the blood, so does not affect the antitumor activity of MTX within the tumor cells.
Recombinant protein drugs pilot platform as the national "11th five-year plan", this creature for more than a decade has been sticking to pay close attention to market segments, different development road of development strategy. The company currently has more than one project at the pre-clinical stage, and actively develop new work project reserves and mammalian cell expression platform.