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Genexine's weekly growth hormone equal to Novo shot in phase 3, teeing up filing in China
Phase 3Drug ApprovalAcquisitionLicense out/inClinical Result
If approved, eftansomatropin alfa will enter a market that already features a once-weekly option.
Genexine’s oneftansomatropin alfamone has matched daily injections in a pivotal trial in China, teeing it and its partners I-Mab and Jumpcan up to file for approval next year and prepare to launch the medicine.
Genexinee 3 clinical trial compared eftansomatropin alfa, Genexine’s long-acting growth hormone, to Novo Nordisk’s daily inI-Mabble NJumpcanpin in children with growth hormone deficiency. After 52 weeks, the mean annualized height velocity in the eftansomatropin alfa arm was 10.76 cm a year, compared to 10.28 cm a year in the control cohort. The result caused the trial to meet its primary endpoint.
“We are pleased with the results froeftansomatropin alfatrGenexinehis demonstrategrowth hormone and Novo Nordiskthis potential best-Norditropinug to treat childrgrowth hormone deficiencyficiency,” Genexine CEO Neil Warma said in a statement. “Thiseftansomatropinnt 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-Mab, the rights to develop, manufacture and commercialize eftansomatropin alfa in China in 2015 as pagrowth hormone deficiencyworGenexineillion upfront plus up to $40 million in milestones tied specifically to tGenexineh hormone. I-Mab partnered with Jumpcan to commercialize the drug in China in 2021.
Genexineaborators plan to file for approval in China next year. IfI-Maboved, eftansomatropin alfa will enter a market that alreftansomatropin alfa-weekly option. GenSci won approval for its once-weekly Jintrolong in China after showing the treatment is noninferior to daily injections.I-MabJumpcan
Jintrolong and eftansomatropin alfa are part of a wave of once-weekly growth eftansomatropin alfaing Ascendis Pharma’s Skytrofa and Pfizer’s Ngenla. The developerGenSci achieved once-weekly dosing usingJintrolong of approaches. Jintrolong is a pegylated growth hormone, whereas eftansomatropin alfa uses hyFc, a component made of a portion of human immunoglobulin D and G4.
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