Alphamab’s KN057 Earns FDA Orphan Drug Designation for Hemophilia B Treatment

Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has received another orphan drug designation (ODD) from the US FDA for its monoclonal antibody (mAb) KN057, which targets the tissue factor pathway inhibitor (TFPI). This new ODD is for the potential treatment of hemophilia B, following the initial ODD for hemophilia A granted in March. KN057 is anticipated to provide both preventative and therapeutic benefits for hemophilia types A and B, irrespective of inhibitor status, due to its novel mechanism of action and molecular design. The drug is currently undergoing two Phase III clinical trials in China, with preliminary validation of its safety and efficacy from prior trials. Additionally, Alphamab has entered into a lucrative licensing agreement with Grand Life Sciences for Greater China, valued at up to RMB 500 million, including rights payment and tiered sales commission.- Flcube.com