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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 | view | 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 |