Un­fazed by OS flop, Zai Lab eyes im­mi­nent Chi­na fil­ing for Macro­Gen­ic­s' HER2 drug

Macro­Gen­ics’ an­ti-HER2 drug may have run in­to some trou­ble with its US da­ta, but in Chi­na, part­ners at Zai Lab are get­ting a clear go-ahead sig­nal.

The an­ti­body, mar­ge­tux­imab, aced a bridg­ing study among Chi­nese pa­tients with ad­vanced HER2 breast can­cer, with a haz­ard ra­tio for pro­gres­sion-free sur­vival of 0.69 fa­vor­ing the com­bi­na­tion of mar­ge­tux­imab plus chemother­a­py, sug­gest­ing con­sis­tent safe­ty and ef­fi­ca­cy as seen in the glob­al pop­u­la­tion. Zai Lab is now plot­ting a BLA sub­mis­sion by the end of the year — one year af­ter Macro­Gen­ics scored its first FDA ap­proval.

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