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KDDF-201110-18 Global pre-clinical trial and CTA in the EU for a next generation long-acting human growth hormone(Metabolic Disorders, Protein) [01.04.2013]

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Development and Market Objectives

  • •    To develop a long-acting (biweekly or monthly administration) human growth hormone, GX-H9, with little immunogenicity and side effects. Non-clinical testing is completed and CTA will be approved in Europe.

Unmet Medical Need & Target Patients

•      The targets are child and adult patients with growth hormone deficiency. The size of the market was $3.2 billion in 2012 and is increasing by 13.4% every year.

•      Major unmet medical need for growth hormone deficiency is inconvenience in patient due to daily injection. The improvement of dosing intervals by longer half-life with emhanced efficacy will provide convenience to patients and reduce cost.
 

Status

•      Pre-Clinical Study: Transfer and validation of non-clinical methods, DRF/MTD, and 4 weeks of repeated toxicity test have been completed. The final manufactured product for clinical trials is currently being produced.

•      Agreement of joint development with a domestic pharmaceutical company, Handok, will facilitate overall development of long-acting human growth hormone (contract made in June of 2012).

Intellectual Property

•      Registrated in Korea, US and Singapore; PCT/KR2011/156826

•      “Immunoglobulin fusion proteins”

•      Non-infringement on preceding patents are confirmed by five different patent offices.

Competitive Advantages

•      First-generation of hGH therapies have an inconvenience of daily injection (approximately more than 1,000 times in average treatment period of 3.6 years.

•      Genexine’s GX-H9 is a potential therapeutics providing convenience of biweekly or monthly administration as well as high efficacy by proprietary “hybrid Fc” technology.

Indication

PGHD (pediatric growth hormone deficiency), AGHD (adult growth hormone deficiency)

Research Period

Feb.1,2012 ~ Aug.30,2013

Company

Genexine Co., Ltd

Developmental Stage

Preclinical

Additional Information

None

Contact Information

Contact
Address Company Name: Genexine Co., Ltd.
WebSite Homepage: http://www.genexine.com Contact Person: Do-Soo Jang
E-mail: dsjang@genexine.com Contact: 82-31-628-3263

Related Projects

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Global Phase 2 study in pediatric patients (PGHD) of next generation human growth hormone drug (GX-H9) and global License out Project view
Global Phase 2 study (AGHD) of next generation human growth hormone drug (GX-H9) in EU/KR and Approval of PGHD trial in EU Project view
KDDF-201308-07 Conduct and Completion of a Global Clinical Phase I Trial of a Next-Generation Human Growth Hormone Product Project view
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