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
2-13 Chemical Drug / Glecaprevir/Pibrentasvir / AbbVie Deutschland GmbH Co. KG EU 2017-07-26 Infectious diseases
Hepatitis C
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-14 Chemical Drug / Bictegravir, emtricitabine, and tenofovir alafenamide / Gilead Sciences,Inc. US 2018-02-07 Infectious diseases
Acquired Immune Deficiency Syndrome (AIDS)
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-15 Biological Product Dispersible tablets Bosentan 32 mg Janssen-Cilag International N V EU 2009-06-03 Respiratory system disorders
Pulmonary hypertension
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-16 Chemical Drug / Sildenafil Citrate / Pfizer Inc. US 2009-11-18 Respiratory system disorders
Pulmonary hypertension
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-17 Chemical Drug / Beraprost sodium / 東レ株式会社 Japan 2007-10-19 Respiratory system disorders
Pulmonary hypertension
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-18 Biological Product / Recombinant human C1-inhibitor / Pharming Group N.V. EU 2010-10-28 Skin disorders
Hereditary Angioedema (HAE)
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-19 Biological Product / Ustekinumab / Janssen Biotech, Inc. US 2016-09-23 Gastrointestinal diseases
Crohn's disease (CD)
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-20 Chemical Drug / Sodium zirconium cyclosilicate / AstraZeneca AB EU 2018-03-22 Hyperkalemia
Hyperkalemia in adults
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-21 Biological Product / Adalimumab / AbbVie Deutschland GmbH Co. KG EU 2016-06-24 Eye disorders
Noninfectious intermediate uveitis, posterior Uveitis, or panuveitis
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings
2-22 Biological Product / Alemtuzumab / Sanofi Belgium EU 2013-09-12 Nervous system disorders
Multiple sclerosis (MS)
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings