Handok-Genexine Long-Acting hGH Therapeutic “GX-H9”

Receives Approval for Phase I Trial in Europe

Handok(Young Jin Kim, CEO) and Genexine Inc.(Young Chul Sung, CEO) announced the approval by Competent Authority in the Netherlands (CCMO: Centrale Commmissie Mensgebonden Onderzoek, IEC:Institutional Ethics Committee) for the phase I clinical trial of GX-H9, a long-acting human growth hormone(hGH) co-developed by Handok and Genexine.

Human growth hormone therapeutics treat dwarfism(growth defect), with a global market size of approximately 3 billion in 2012. A recent expansion into the adult market for anti-aging purposes positions this biologic for blockbuster status with a considerable market volume. In ‘GX-H9’ Genexine’s proprietary antibody-fusion technology(hyFc) was applied to the human growth hormone. As an innovative next-generation long-acting biologic, ‘GX-H9’ is administered once or twice a month compared to conventional therapeutics which requires daily administration.

In February 2012, ‘GX-H9’ was designated as the first project supported by the Korea Drug Development Fund. Handok and Genexine, as strategic partners, entered into a co-development and technology transfer agreement last July for the clinical development and commercialization of ‘GX-H9.’ Preclinical studies of ‘GX-H9’ was completed successfully in Europe last July, and phase I clinical trials are to be started late August in hospitals situated in the Netherlands by the global contract research organization PRA.

Genexine`s CEO Young Chul Sung stated that “antibody-fusion technology(hyFC) maintains the therapeutic efficacy of hGH while significantly extending the half life. As it was designed for stability and does not cause pain on administration, this next-generation biotechnology is quite suitable for use in hGH therapeutics, which are administered for extended periods to children.”

Handok’s Chairman and CEO Young Jin Kim said, “GX-H9, a next generation long-acting hGH product is expected to take over and expand upon the growth hormone market. We aim to license out this product at a high value to a global pharmaceutical company, after successfully completing international-standard clinical trials in Europe.”