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China Fast-Tracks Multiple HCV Drugs With Access In Mind

 
• By Brian Yang

All eyes on a list of selected oral hepatitis C drugs that are expected to win out in China's notoriously lengthy approval battle, amid a potentially huge opening as Chinese HCV patients switch from interferon to all oral therapies.

BEIJING – Right before the Golden Week holiday weekend, the China FDA's drug review arm, the Center for Drug Evaluation (CDE), has released details of two sets of drugs – mainly for the hepatitis C virus (HCV) - that are to receive accelerated fast-track approval reviews.

The batches of designations come amid a wave of new and highly effective all-oral therapies approved for HCV, which is highly prevalent in China, although none had so far been...

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