Handok-Genexine Long-Acting hGH Therapeutic “GX-H9” Receives Approval for Phase I Trial in Europe

August 20, 2013 I 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.”

About hyFc Technology

hyFc (hybrid Fc) is Genexine’s proprietary platform technology to generate long-acting protein therapeutics, derived from hybridization of non-cytolytic immunoglobulin Fc portions of IgD and IgG4 without any site directed mutagenesis. While hyFc extends the half-life of the Fc fused drug molecule mainly based on FcRn recycling mechanism, hyFc also minimizes the loss of bioactivity of the drug molecule, as IgD has the highest hinge flexibility among Igs. The junction site of IgD/IgG4 fusion is buried in the unexposed region which prevents the adverse immunogenicity and cleavage by enzymes. Therefore, hyFc fused protein therapeutics can be generally more potent, less immunogenic and more stably long-acting compared with those derived from previous long-acting technologies. With a number of derivatives of hyFc platform, Genexine’s hyFc technology can be applied to the broad range of drug moiety including small peptides and proteolytic enzymes.

About Handok

Since its establishment in 1954, Handok (CEO, Kim, Young-jin; www.handok.co.kr) has contributed to the advancement of the pharmaceutical industry in Korea by working in alliance with global pharmaceutical companies including Hoechst, Aventis, Sanofi and many others. Handok is growing into a leading pharmaceutical company in Korea through continuous innovation based on its ethical management policies. In 2013, Handok changed its company name from Handok Pharmaceutical Co., Ltd to Handok Inc. and declared its vision to become Korea’s leading global total healthcare company. The company currently consists of 720 employees and officials are employed at the head office located at Yeoksam-dong in Seoul, 10 regional offices and at its factory located at Eumseong, Chungbuk. HANDOK’s flagship ETC products are ▲ Amaryl, Amaryl M, Amaryl Mex and GalvusMet for antidiabetics ▲Teveten, Tritace, Tracleer and Triapin for the treatment of hypertension ▲ Xatral XL for the treatment of the prostate ▲ Daxas, Onbrez and Tracleer for the treatment of pulmonary disease ▲ Adacel and Pneumo 23 injection (vaccine). Also Handok’s representative OTC products include Festal as a digestive medicine and Nicostop designed to assist those who quit smoking. Also, HANDOK is promoting ▲ medical devices and diagnostics ▲ food supplements, NatureSet and ▲ medical nutrition (food for special medical purpose) products.

About Genexine, Inc.

Genexine is a fast-growing and progressive Korean biotechnology company, specializing in pioneering therapeutic DNA vaccines and innovative long-acting Fc fusion protein drugs based on Genexine’s proprietary hyFc platform technology. Genexine’s pipelines, currently at various stages of clinical development, target clinical indications including anemia, neutropenia, growth hormone deficiency, HPV derived CIN(cervical intraepithelial neoplasia), hepatitis B, etc. Founded in 1999, Genexine is headquartered in the Pangyo Techno Valley, a multidisciplinary industrial/research complex located in Seongnam City near Seoul, South Korea.

Questions?

Handok Communications Division

Ju Hyun Lee, Director (82-2-527-5136 / This email address is being protected from spambots. You need JavaScript enabled to view it.)

Dong Min Yoon (82-2-527-5333 / This email address is being protected from spambots. You need JavaScript enabled to view it.)

PRONE, PR agency

Gyu Chang Jung, Team leader (82-2-6370-3119/ This email address is being protected from spambots. You need JavaScript enabled to view it.)

Ah Yeon Ahn, Assistant Manager (82-2-6370-3135 / This email address is being protected from spambots. You need JavaScript enabled to view it.)

SOURCE: Handok

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