Af­ter Lil­ly's sin­til­imab shel­lack­ing, Chi­na-on­ly on­col­o­gy tri­als are fac­ing a new — and un­fa­vor­able — re­al­i­ty at the FDA

As ex­pect­ed, Eli Lil­ly and Chi­nese part­ner In­novent faced a fir­ing line at yes­ter­day’s ODAC, forced to re­spond to a seem­ing­ly nev­er-end­ing list of is­sues with their ap­pli­ca­tion for PD-1 drug sin­til­imab. That will like­ly set up an un­fa­vor­able de­ci­sion from the FDA and tar­nish sin­til­imab’s chances mov­ing for­ward.

But what does yes­ter­day’s opin­ion mean for the fu­ture of Chi­na-on­ly tri­als look­ing to crack the US mar­ket? Ac­cord­ing to an­a­lysts, the out­look doesn’t look good.

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