Genexine Growth Hormone 'GX-H9' Achieves Success in China Phase 3 Clinical Trial

Genexine announced on the 30th that its long-acting pediatric growth hormone treatment ‘GX-H9 (substance name Eftansomatropin alfa)’ met the primary endpoint in the Phase 3 clinical trial results in China.

The new headquarters of Genexine, 'Genexine Progen Bio Innovation Park' (left building), located in Magok, Gangseo-gu, Seoul. On the right is the research institute of its affiliate Handok, 'Handok Future Complex.'
[Photo by Lee Chunhee]

The Phase 3 clinical trial of GX-H9, conducted by China-based Nasdaq-listed company iMap, was approved by the China Center for Drug Evaluation (CDE) in October 2020. The trial was a multicenter, randomized, open-label, active-controlled study targeting pediatric growth hormone deficiency (PGHD) patients in China.

Genexine stated that the results demonstrated both the efficacy and safety of GX-H9 compared to the existing daily growth hormone product, Norditropin. The trial was designed to prove the non-inferiority of GX-H9 to Norditropin by comparing the annual height velocity (AHV) at week 52.

The results showed that the daily administered control group grew approximately 10.28 cm, while the once-weekly administered GX-H9 group grew about 10.76 cm. The difference in growth rate was 0.47 cm (95% CI -0.06 to 1.00), statistically significantly meeting the primary endpoint. No drug-related adverse effects such as injection site lipoatrophy or insulin resistance were observed, confirming safety comparable to Norditropin.

GX-H9 is a long-acting growth hormone developed based on Genexine’s proprietary long-acting platform technology ‘hybrid (hy)Fc’. It is being co-developed with Handok. Compared to the first-generation daily growth hormone products, it is a second-generation pediatric growth hormone deficiency treatment with a once-weekly dosing schedule. This reduces injection-related resistance among pediatric patients who previously had to receive daily injections, thereby improving patient compliance and potentially leading to relatively higher growth rates.

According to market research firm IMARC Group, the global growth hormone market size is expected to grow from $5.3 billion (approximately 7 trillion KRW) last year to $8.5 billion (approximately 11 trillion KRW) by 2028, at a compound annual growth rate of 8.1%. Particularly, the Chinese market is projected to grow from $1 million (approximately 130 million KRW) in 2020 to $3 billion (approximately 4 trillion KRW) by 2030, with an annual growth rate of 43%. Therefore, even securing about 20% market share targeted by Genexine could generate annual sales of $600 million (approximately 792.6 billion KRW).

The company expects to receive the final Phase 3 clinical trial results of GX-H9 within this year and plans to submit a Biologics License Application (BLA) to the Chinese CDE next year.

Neil Worma, CEO of Genexine, is being interviewed by Asia Economy. [Photo by Genexine]

Neil Warma, CEO of Genexine, said, “GX-H9 is significant as a product developed using Genexine’s long-acting platform hyFc and is now challenging commercialization.” He added, “We are very satisfied to have clearly demonstrated the safety and efficacy of GX-H9, a growth hormone deficiency treatment for pediatric patients, through this study. We will continue to do our best to commercialize leading products in various countries.”

This content was produced with the assistance of AI translation services.