The State Food and Drug Administration of China has granted approval to Apexigen's partner Simcere Pharmaceutical Group to begin first-in-man trials with APX003, which is also known as BD0801, for the treatment of cancer.
With this approval, APX003/BD0801 becomes the first humanized monoclonal antibody derived from Apexigen's proprietary antibody technology platform to enter human trials.
APX003/BD0801 is being developed in China through an active partnership between Apexigen and Simcere. Apexigen has collaborated with Simcere to add its antibody development expertise and experience to the advancement of the APX003/BD0801 programme. This approval marks the success of the dedicated work of the collaboration team to file and defend an IND application, and initiates the next phase of collaboration in clinical development.
"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 and CEO. "We look forward to continuing the collaboration with Simcere and advancing AXP003/BD0801 into clinical development."
APX003/BD0801 is a humanized monoclonal antibody directed against VEGF and is under development for the treatment of multiple malignancies.
Apexigen is a biopharmaceutical product development company advancing a pipeline of novel product candidates with the potential to address life-threatening and difficult to treat diseases.