To address the current unmet medical need, wehave developed a novel manufacturing technology (Patents are granted in both US and China, as well as applications in other countries) for recombinant human factor VIII, which will bring a revolutionary change in the treatment landscape for hemophilia A patients.
With our exciting new process, the recombinant FVIII expression level has been increased significantly more than the production levels currently achievable by other companies and with the highest quality and specific activity - this will make the drug more generally available and considerably more affordable on a commercial scale. We recently completed three successful GMP production runs at the 200L scale, and based on the actual cost, we believe that the recombinant FVIII can be made for a few cents per international unit of FVIII, and possibly even less, depending on the scale.
Our therapeutic pipeline includes therapies to treat bleeding in hemophilia A and von Willebrand disease, acute bleeding in other traumatic indications, reducing thrombotic events in related pathologies and targeting to eliminate cancer, including metastatic tumors.
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