BRIEF—TJ Bio seeks China nod for growth hormone therapy

TJ Bio has reportedly submitted a biologics license application (BLA) to China’s Center for Drug Evaluation for GX-H9 (eftansomatropin alfa), a second-generation therapy for pediatric growth hormone deficiency.

GX-H9, co-developed by Genexine and Handok, is based on Genexine’s proprietary hyFc platform technology, which enables long-acting drug delivery.

This reduces the frequency of injections to once a week, compared to the daily administration required by traditional growth hormone therapies.

Clinical trials conducted by TJ Bio in China demonstrated that GX-H9 is non-inferior to Norditropin (somatropin), a daily growth hormone therapy by Novo Nordisk.

TJ Bio has held the rights to develop and commercialize GX-H9 in China since 2015 and partnered with Jumpcan Pharmaceutical, a specialist in pediatric treatments, for commercialization in 2021.