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The Korea Herald
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THE INVESTOR
March 29, 2024

Bio

Handok’s growth hormone designated as orphan drug by USFDA

  • PUBLISHED :November 16, 2016 - 16:00
  • UPDATED :November 16, 2016 - 16:00
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[THE INVESTOR] South Korean pharmaceutical company Handok announced on Nov. 16 that its long-acting growth hormone GX-H9, being jointly developed by Genexine, has been designated as an orphan drug by the US Food and Drug Administration. 

This grants a number of development incentives including fast-track review of the plans for clinical trials, tax credits, redemption of fees and exclusive rights in the market for seven years. 

Applied with Genexine’s hybrid Fc fusion technology, GX-H9 is a next generation long-acting growth hormone that can be injected once a week or twice a month, instead of the daily administration required by existing drugs for the growth hormone deficiency. 

The symptoms of the hard-to-treat rare disorder can cause multiple symptoms including less muscle, reduced bone density, and changes in the makeup of the blood cholesterol. In children it can cause dwarfism and growth failure, seriously affecting the quality of life. 

The pharmaceutical companies have been developing the treatment since signing an agreement in 2012 and GX-H9 is currently undergoing phase 2 clinical trials in Europe. 

By Hwang You-mee (glamazon@heraldcorp.com)

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