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Agreements

Date: 2017-02-21

Type of information: Production agreement

Compound: GX-H9 - recombinant growth hormone fused to hyFc

Company: Genexine (Republic of Korea) CMC Biologics (Denmark - USA)

Therapeutic area:

Type agreement: manufacturing - bioproduction

Action mechanism:

  • hormone. GX-H9 is next-generation, long-acting recombinant human growth hormone (rhGH) consisting of recombinant growth hormone genetically fused to Genexine’s proprietary hybrid Fc (hyFc) platform, giving it extended half-life and potentially better safety profile. Compared to the current daily injection therapy, GX-H9 is being evaluated as weekly and twice-monthly dosing regimens to treat growth hormone deficiency (GHD).
  • GX-H9 is being co-developed with Handok under a strategic partnership. It has been granted orphan drug designation for the treatment of growth hormone deficiency in the US.

Disease:

Details: • On February 21, 2017, CMC Biologics and Genexine announced that they have entered into a manufacturing agreement for the process transfer and cGMP manufacturing of Genexine’s GX-H9.

Financial terms:

Latest news:

Is general: Yes