TNT gets clearance in China

Iodine-131-radiolabeled tumor necrosis therapy (TNT) has received marketing approval for lung cancer treatment in the People’s Republic of China, according to biopharmaceutical developer Peregrine Pharmaceuticals and its Chinese partner, MediPharm Biotech. I-131-labeled TNT was approved for the treatment of stage III and stage IV advanced lung cancer through either intravenous or intratumoral administration.

Prior to market launch, however, the State Food and Drug Administration (SFDA) of China must inspect and approve the manufacturing facility that will manufacture the TNT monoclonal antibody, according to Peregrine of Tustin, CA. The timing and specific requirements of this process are uncertain, Peregrine said.

By AuntMinnie.com staff writers
August 13, 2003

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