Coherus CEO Denny Lanfear (L) and Junshi CEO Li Ning

Two months af­ter CRL, FDA ac­cepts Co­herus, Jun­shi's re­sub­mis­sion for PD-1 stud­ied in Chi­na

Chi­na-on­ly clin­i­cal da­ta has not fared well be­fore the FDA this year. But in one case, the reg­u­la­to­ry agency might be will­ing to budge a lit­tle.

Co­herus Bio­Sciences, the US part­ner for Jun­shi Bio­sciences, an­nounced Wednes­day morn­ing that the FDA has ac­cept­ed a BLA re­sub­mis­sion for its PD-1 drug two months af­ter a CRL. The com­pa­nies are seek­ing a nod for tori­pal­imab plus chemother­a­py in first-line ad­vanced re­cur­rent or metasta­t­ic na­sopha­ryn­geal car­ci­no­ma (NPC), plus tori­pal­imab alone for sec­ond-line and lat­er re­cur­rent or metasta­t­ic NPC af­ter plat­inum-con­tain­ing chemother­a­py.

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