Genexine's Chinese partner applies for product approval of long-acting growth hormone therapy

Genexine said Monday that TJ Bio, its Chinese partner, has submitted a biologics license application (BLA) to China’s Center for Drug Evaluation (CDE) for GX-H9 (ingredient: eftansomatropin alfa), a second-generation pediatric growth hormone deficiency (GHD) therapy.

Co-developed by Genexine and Handok, GX-H9 uses Genexine’s proprietary hyFc long-acting platform technology.

Genexine stressed that the drug significantly improves patient convenience by requiring only once-weekly administration, compared to the daily injections of traditional growth hormone therapies. This will alleviate the daily injection burden for pediatric patients and their families and enhance treatment adherence.

Clinical trials conducted by TJ Bio in China demonstrated the non-inferiority of GX-H9 compared to Novo Nordisk's first-generation daily growth hormone drug, Norditropin.

In a phase 3 trial targeting pediatric GHD patients, GX-H9 achieved an annual height velocity (AHV) of 10.76 centimeters over 52 weeks with once-weekly administration, outperforming the control group’s 10.28 cm AHV under similar conditions.

Additionally, no significant adverse effects, including lipoatrophy or insulin resistance, were observed, confirming GX-H9’s superior convenience, efficacy, and safety compared to first-generation therapies.

TJ Bio, formerly I-Mab Biopharma, acquired the development and commercialization rights for GX-H9 in China from Genexine in 2015. In 2021, TJ Bio entered a commercialization partnership with Jumpcan Pharmaceutical, a Chinese pharmaceutical company specializing in pediatric treatments.

“This BLA submission in China marks a significant milestone as it represents Genexine’s second BLA application using our hyFc platform technology, following the approval of Efesa in Indonesia,” Genexine CEO Hong Sung-june said. “We will continue our strategic collaboration with TJ Bio to ensure the successful launch of GX-H9 in the Chinese market and actively pursue global market entry.”

According to Frost & Sullivan, the Chinese growth hormone market was valued at about $600 million in 2018. With a projected annual growth rate of 15.7 percent, it is expected to reach $3.45 billion by 2030.