Description

The overseas new drugs with urgent clinical needs in China are selected by National Medical Products Administration and National Health Commission. These drugs' MAHs can apply for fast-track marketing approval so that the Center for Drug Evaluation will prioritize the review of the products. 

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SN Drug Name Classification Dosage Form API/Active Substance Strength MAH First Approved in First Approved in EU/US/Japan Therapeutic Domain Indication Source
1-37 Chemical Drug / Vernakalant hydrochloride / Cardiome UK Limited EU 2010-09-01 Cardiovascular and cerebrovascular diseases
Atrial fibrillation (AF)
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings
1-38 Biological Product / Vorapaxar / Merck Sharp And Dohme Corp US 2014-05-08 Cardiovascular and cerebrovascular diseases
Myocardial infarction (MI), peripheral artery disease, thrombosis cardiovascular disease
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings
1-39 Chemical Drug / Ledipasvir and sofosbuvir / Gilead Sciences Inc US 2014-10-10 Infectious diseases
Hepatitis C
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings
1-40 Chemical Drug / Sofosbuvir, velpatasvir, and voxilaprevir / Gilead Sciences Inc US 2017-07-18 Infectious diseases
Hepatitis C
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings
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