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 |
| 1-17 | view | Biological Product | / | Apremilast | / | Celgene Corp | US | 2014-03-21 | Skin/immune system disorders |
Psoriatic arthritis, psoriasis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-18 | view | Biological Product | / | Rilonacept | / | Regeneron | US | 2008-02-27 | Immune system disorders |
Cryopyrin-associated periodic syndrome (CAPS), Mowat-Wilson syndrome (MWS), familial cold autoinflammatory syndrome (FCAS), familial chylomicronemia syndrome (FCS)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-19 | view | Chemical Drug | / | Tetrabenazine | / | Prestwick | US | 2008-08-15 | Mental disorders, nervous system disorders |
Huntington's disease (HD)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-20 | view | Biological Product | / | Ecallantide | / | Dyax Corp. | US | 2009-12-01 | Circulatory system disorders |
Hereditary Angioedema (HAE)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-21 | view | Biological Product | / | Velaglucerase Alfa | / | Shire Human Genetic Therapies Inc | US | 2010-02-26 | Endocrine and metabolic disorders |
Gaucher disease
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-22 | view | Chemical Drug | / | Tafamidis | / | Pfizer Ltd | EU | 2011-11-16 | Nervous system disorders |
Transthyretin-related familial amyloid polyneuropathy (TTR-FAP), transthyretin-related amyloidosis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-23 | view | Biological Product | / | Taliglucerase alfa | / | Pfizer Inc | US | 2012-05-10 | Endocrine and metabolic disorders |
Gaucher disease
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-24 | view | Biological Product | / | Lomitapide | / | Aegerion Pharmaceuticals Inc | US | 2012-12-21 | Cardiovascular and cerebrovascular diseases |
Homozygous familial hypercholesterolemia (FH), hypercholesterolemia
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-25 | view | Chemical Drug | / | Mipomersen sodium | / | Genzyme Corp | US | 2013-01-29 | Cardiovascular and cerebrovascular diseases |
Homozygous familial hypercholesterolemia (FH)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-26 | view | Biological Product | / | Dinutuximab | / | UnitedTherapeuticsCorporation | US | 2015-03-10 | Neoplasm |
Neuroblastoma
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |