Handok (CEO Kim Young-Jin) and Genexine (CEO Sung Young-Chul) announced that their co-developed long-active growth hormone, GX-H9, has been approved by the State Institute of Drug Control (SIDC) in Slovakia, Europe for Phase 2 Study on adult patients.

In Korea, Phase 2 Study on GX-H9 has been ongoing since last September, and with this approval in Slovakia, it is expected that 7 other European countries including Germany and France will approve clinical trials in February. CEO Sung Yong-Chul of Genexine states that “Global phase 2 studies for children from countries including the U.S. and Europe are also underway; in the second half of this year, we expect global clinical trials to be conducted on both children and adults.”

Growth hormones are protein drugs widely used for treating illness such as pediatric growth retardation and development disabilities as well as for preventing adult illnesses and for anti-aging hormone therapy. GX-H9 is an innovative, next-generation long-acting bio pharmaceutical made with Genexin’s exclusive Hybrid Fc technology. Compared to other hormone drugs that require daily injections, GX-H9 can be administered monthly or biweekly.

The global market for growth hormones is 3.5 trillion won (based on 2012), in which Novo Nordisk, Pfizer, and Genetech’s daily-administered hormone drugs account for 75% of the market. The first-generation hormonal drugs’ must be administered more than 300 times a year, and these inconvenient limitations increase global market demand for a long-acting growth hormone. In December 2014, Pfizer had licensed-in a weekly growth hormone in development with an up-front investment of 295 million dollars.

 “The innovativeness and commercial viability of GX-H9 had already been recognized by the government, and the Preclinical and Phase I European Trial has all been funded by the Korea Drug Development Fund. We see the European approval as an opportunity for Handok to obtain global clinical results on both adults and children to develop the best long-acting growth hormone,” said Kim Young-Jin, CEO of Handok.