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Going Global Gets Stuck, Chinese Drug Makers CRL Show What Not To Do

Holistic not opportunistic approach required

 
• By Brian Yang

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.

Mediation (Andrii Yalanskyi/Alamy Stock Photo)
FDA CRLS TO JUNSHI, HUTCHMED SHOW WHAT NOT TO DO FOR CHINESE DRUG MAKERS GOING GLOBAL • Source: Alamy (Andrii Yalanskyi / Alamy Stock P/Alamy Stock Photo)

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.

The Shanghai firm along its US partner Coherus BioSciences, Inc

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