ARTICLE | Regulation
FDA’s repudiation of China-only data puts EQRx, Coherus PD-1s in spotlight
Development programs similar to Tyvyt’s could be at risk, but some Chinese PD-1s could pass muster with FDA
February 12, 2022 1:01 AM UTC
Following FDA’s public, multifaceted repudiation of Tyvyt from Innovent and Eli Lilly, sponsors will have to reassess plans to file BLAs in the U.S. for checkpoint inhibitors developed with clinical data solely or predominately from China.
The events of the last week could be particularly relevant for PD-1s that are being developed for the same first-line non-small cell lung cancer (NSCLC) indication as Tyvyt sintilimab, including toripalimab from Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180) and Coherus BioSciences Inc. (NASDAQ:CHRS) and sugemalimab from CStone Pharmaceuticals Co. Ltd. (HKEX:2616) and EQRx Inc. (NASDAQ:EQRX)...