South Korea-based Genexine (KOSDAQ: 095700) has announced that its long-acting growth hormone product candidate, eftansomatropin alfa (GX-H9; TJ101), has achieved Phase III endpoints in a clinical trial conducted in China. The study, CTJ101PGHD301, demonstrated the safety and efficacy of the drug in children with growth hormone deficiency.
Eftansomatropin Alfa’s Efficacy and Safety Profile
Eftansomatropin alfa successfully met its primary endpoint of annualized height velocity (AHV) at week 52, showing non-inferiority to Norditropin. The drug was administered weekly, compared to Norditropin’s daily injection regimen. The mean AHV was 10.76 cm/year for eftansomatropin alfa and 10.28 cm/year for Norditropin. There were no drug discontinuations due to treatment-related adverse events, and the safety profile was comparable to Norditropin. A Biologics License Application (BLA) filing is planned for the drug in China in 2024.
Eftansomatropin Alfa’s Differentiated Approach
Eftansomatropin alfa is a differentiated long-acting recombinant human growth hormone (rhGH) based on Genexine’s hybrid Fc fusion protein technology platform. It triggers a growth-stimulating effect in various tissues, including osteoblasts and chondrocytes, to promote bone growth. The drug is considered a potential best-in-class product due to its extended half-life, which results in significantly fewer injections (weekly versus daily) and an improved safety profile.
Joint Venture and Commercialization Plans
Genexine, Tasly, and C-Bridge Capital established a joint venture (JV) in October 2015, acquiring China rights to the drug and two others for USD 20 million. The JV and I-Mab merged into I-Mab Biopharma in 2017. In November 2021, I-Mab and Jumpcan Pharmaceutical Group entered into a strategic collaboration, with I-Mab as the marketing authorization holder (MAH) of the product, supplying it to Jumpcan at an agreed cost, while Jumpcan will handle commercialization. Jumpcan paid around USD 34 million upfront for those rights in a deal worth up to USD 312 million in total.-Fineline Info & Tech
