I-Mab to seek approval of pediatric growth hormone deficiency drug in China next year after PhIII win

I-Mab Bio­phar­ma said Thurs­day that its long-act­ing, re­com­bi­nant growth hor­mone can­di­date met the pri­ma­ry end­point in a Phase III tri­al, set­ting the stage for its first BLA fil­ing in Chi­na.

The biotech un­veiled topline da­ta in its first-half earn­ings re­port, say­ing a once-week­ly dose of ef­tan­so­ma­t­ropin al­fa was non-in­fe­ri­or to dai­ly in­jec­tions of No­vo Nordisk’s growth hor­mone, Norditropin. Ef­tan­so­ma­t­ropin al­fa works by stim­u­lat­ing pro­duc­tion of growth fac­tor IGF-1 in the liv­er.

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