CMC Biologics, a clinical and commercial manufacturer of therapeutic proteins, has entered into a manufacturing agreement with Genexine, a Pangyo Techno Valley, Korea-based biotechnology company focused on immuno-oncology, metabolic, and orphan diseases, for the process transfer and cGMP manufacturing of Genexine’s recombinant human growth hormone, GX-H9.

GX-H9, being co-developed under a strategic partnership with Handok, a Seoul, Kora-based pharmaceutical company, is a long-acting recombinant human growth hormone consisting of recombinant growth hormone genetically fused to Genexine’s proprietary hybrid Fc platform to give the product an extended half-life and potentially better safety profile, according to CMC Biologics. GX-H9 is being evaluated as in weekly and twice-monthly dosing regimens to treat growth hormone deficiency (GHD). The US Food and Drug Administration has granted GX-H9 orphan drug designation for treating GHD.

Source: CMC Biologics