AsianScientist (Nov. 26, 2012) – Chinese pharma Simcere Pharmaceutical Group has received approval from the State Food and Drug Administration (SFDA) of China to begin first-in-man trials with its humanized monoclonal antibody candidate.
Under a partnership with California-based pharmaceutical company Apexigen, Simcere and Apexigen are actively developing APX003, which is also known as BD0801, for the treatment of cancer.
APX003/BD0801 is a humanized monoclonal antibody directed against vascular endothelial growth factor (VEGF), a growth factor commonly over-expressed in cancers to encourage blood vessel growth.
With this approval, APX003/BD0801 becomes the first humanized monoclonal antibody derived from Apexigen’s proprietary antibody technology platform to enter human trials.
“We’re very pleased to see the IND approval for APX003/BD0801. This is an important milestone for our collaboration with Simcere and for proof-of-concept of our antibody technology platform,” said Dr. Xiaodong Yang, President & CEO of Apexigen.
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Source: Apexigen, Inc.
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