Chinese partners TJ Biopharma and Jumpcan Pharmaceutical (SHA: 600566) have jointly announced that the National Medical Products Administration (NMPA) of China has accepted a Biologic License Application (BLA) for eftansomatropin alfa (TJ101) for review. This product, the first and currently only fusion protein long-acting growth hormone, is anticipated to offer a safe, effective, and more convenient treatment option for children with growth hormone deficiency.
Eftansomatropin Alfa’s Background and Technology
Eftansomatropin alfa is a differentiated long-acting recombinant human growth hormone (rhGH) developed using the hybrid Fc fusion protein technology platform of South Korea-based Genexine (KOSDAQ: 095700). In October 2015, Genexine, Tasly, and C-Bridge Capital established a joint venture (JV) that acquired the China rights to the drug and two others for USD 20 million. This JV was merged into I-Mab Biopharma in 2017. In November 2021, I-Mab and Jumpcan entered into a strategic collaboration where I-Mab will be the marketing authorization holder (MAH) of the product, supplying it to Jumpcan at an agreed cost, while Jumpcan will handle the commercialization. Jumpcan paid approximately USD 34 million upfront for these rights, with the deal potentially worth up to USD 312 million in total.
Significance of the BLA Acceptance
The acceptance of the BLA for eftansomatropin alfa by the NMPA is a significant step towards providing a new therapeutic option for children with growth hormone deficiency in China. The partnership between TJ Biopharma, Jumpcan Pharmaceutical, and I-Mab Biopharma highlights the collaborative efforts within the pharmaceutical industry to bring innovative treatments to market.-Fineline Info & Tech
