[THE INVESTOR] South Korea’s Genexine is attracting attention from global pharmaceutical companies as its long-acting human growth hormone treatment has shown positive interim data from phase 2 clinical trials.

GX-H9, which is targeted for the treatment of adult and pediatric growth hormone deficiency, showed that it can provide a once-weekly alternative to current human growth hormone products that need daily dosage in the multi-national phase 2 trials.

Genexine chairman and chief technology officer Sung Young-chul

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According to Kwak Jin-hee at Eugene Investment & Securities, big pharma firms like Eli Lilly, Roche, Teva and Merck are showing high interest in long-acting pipelines and “there’s a possibility that they could become potential partners of Genexine.”

Once the ongoing phase 2 clinical trials of GX-H9 in pediatric growth hormone deficiency is completed this year, the global companies will seek to sign a deal with Genexine, she said.

Genexine plans to wrap up the clinical study in children between September and October while it has completed the adult growth hormone deficiency trials, according to the company’s official.

“Many domestic drug makers as well as global firms have been contacting us,” the official said.

By receiving an orphan drug designation from the US Food and Drug Administration in November last year, GX-H9 is being held up as a possible blockbuster drug.

The designation provides the firm with development and commercial support such as prioritized FDA review on clinical trials and approvals, credit on clinical trials, exemption from certain regulatory fees and seven years of market exclusivity.

Currently, the market’s top six pharma giants, including Pfizer, Novo Nordisk Pharma and Roche, have dominant market share of 94 percent in daily human growth hormone products.

The market size for growth hormone is currently US$4 billion globally and is expected to grow at an annual rate of 5 percent, according to Genexine.

By Park Han-na (hnpark@heraldcorp.com)