Genexine has reported that the Phase III study of eftansomatropin alfa (GX-H9) for the treatment of children with growth hormone deficiency has met its primary endpoint of annualised height velocity (AHV) at week 52.

Being carried out by Genexine’s partner in China, the active-controlled, multi-centre, open-label, randomised study assessed the safety and efficacy of Genexine’s proprietary long-acting growth hormone, eftansomatropin alfa.

Patients received a weekly injection of eftansomatropin alfa and daily injections of Norditropin.

The mean AHV demonstrated for eftansomatropin alfa was 10.76 (cm/year) while it was 10.28 (cm/year) in Norditropin group with a difference of 0.47 [95% CI -0.06,1.00] and non-inferiority p-value <0.0001.

No drug discontinuation was reported due to adverse events related to the treatment and eftansomatropin alfa was observed to be well tolerated.

Genexine president and CEO Neil Warma said: “This is a significant milestone for Genexine as we demonstrate our ability to bring our novel products to market and the value of our proprietary long-acting hyFc platform.

“We are excited to be preparing to submit the BLA in 2024 and advancing this product to market and to patients in China.

“We remain committed to our efforts to commercialise our leading products in various key markets.”

Handok is co-developing GX-H9 under a strategic alliance with Genexine.

Genexine is also engaged in developing GX-H9 for paediatric growth hormone deficiency, GX-E4 for CKD-induced anaemia, GX-188E for head and neck cancer and cervical cancer, and GX-I7 for multiple cancers.