Phase 3Drug ApprovalAcquisitionLicense out/inClinical Result
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Source: FierceBiotech
If approved, eftansomatropin alfa will enter a market that already features a once-weekly option.
Genexine’s once-weekly growth hormone has matched daily injections in a pivotal trial in China, teeing it and its partners I-MabI-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine.
“We are pleased with the results from this registration trial as this demonstrates clear safety and efficacy in this potential best-in-class drug to treat children with growth hormone deficiency,” GenexineGenexine CEO Neil Warma said in a statement. “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.”
Genexine granted Tasgen Biotech, a company subsequently bought by I-MabI-Mab, the rights to develop, manufacture and commercialize eftansomatropin alfa in China in 2015 as part of a multi-asset deal worth $13 million upfront plus up to $40 million in milestones tied specifically to the growth hormone. I-MabI-Mab partnered with Jumpcan to commercialize the drug in China in 2021.
The collaborators plan to file for approval in China next year. If approved, eftansomatropin alfa will enter a market that already features a once-weekly option. GenSci won approval for its once-weekly Jintrolong in China after showing the treatment is noninferior to daily injections.
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