Although Shanghai Junshi Biosciences Co., Ltd.was considered to have a bigger chance to sail through the FDA approval process, the truth is still heartbreaking for other Chinese drug makers eyeing an entry in the US market with a promising anti-cancer drug.
Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do
Holistic not opportunistic approach required
Chinese drug makers have more to lament and plenty to learn from as Junshi, HutchMed follow Innovent Bio with FDA rejections. A holistic not opportunistic approach is needed, one ex-FDA expert suggests.
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