Long–acting growth hormone “GX-H9,” currently being jointly developed by Handok and Genexine, has been selected as a project of the new comprehensive, multi-ministry drug development program, securing funds for clinical research and development

Long–acting growth hormone “GX-H9,” currently being jointly developed by Handok (Chairman and CEO: Kim Young-jin) and Genexine (President: Sung Young-chul), has been selected as a project of the new comprehensive, multi-ministry drug development program. As a result, an agreement was signed with the Korea Drug Development Fund (KDDF) (CEO: Joo Sang-aun) on 16.

Through this agreement, Handok and Genexine will receive funds for the global clinical research and development of GX-H9. The support includes approval for Phase 2 of the global clinical trials for growth hormone–deficient pediatric and adult patients. Under the agreement, Genexine will be the principal research institution, and Handok will be the participating company.

Growth hormone is a peptide hormone widely used to treat growth hormone deficiency-induced growth retardation and development impairment in children and as a hormone therapy for the prevention of adult diseases and in anti-aging procedures. GX-H9 is a new and innovative, long–acting biopharmaceutical created through the application of a proprietary antibody fusion technique (Hybrid Fc) developed by Genexine. Characterized by its long-lasting effect, GX-H9, in contrast to growth hormone, which must be administered daily, could be injected only once or twice a month.

Handok Chairman Kim Young-jin announced, “GX-H9 has the potential to significantly increase patient convenience, and its innovation and commercial value have been recognized by the government.” He went on to say, “Through our collaboration with the KDDF, we will make our best efforts to have GX-H9 approved worldwide.”

Genexine President Sung Young-chul stated, “Through the clinical trial for adult patients currently underway and the clinical trial for pediatric patients scheduled for the latter part of this year, we believe that the effectiveness of this next–generation growth hormone will be proven. Based on this success, we will aggressively pursue more new drug technology transfers worldwide.”

GX-H9 is the first project supported by the KDDF. The preclinical study was completed successfully and the technology was transferred to Handok in 2012, with both companies continuing to collaborate as strategic partners. In April 2014, Phase 1 of the European clinical trial was completed, and Phase 2 is currently being carried out for adult growth hormone deficient patients in eight countries in Europe as well as in Korea. In addition, Phase 2 of a multinational clinical trial for growth hormone deficient pediatric patients suffering from growth retardation caused by damage to the hypothalamus or developmental impairment is being prepared in a total of 16 countries, with Europe as the center.

The KDDF is a national, multi-ministry research and development foundation that supports all phases of clinical studies and is funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry, and Energy, and the Ministry of Health and Welfare. Having supported the development of new drugs in various fields, the foundation has now launched a global drug development project with a budget of KRW 1.06 trillion to be administered over nine years until 2020.