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 |
| 1-7 | view | Chemical Drug | / | Fingolimod HCl | / | Novartis Pharmaceuticals Corp | US | 2010-09-21 | Immune system disorders |
Multiple sclerosis (MS)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-8 | view | Biological Product | / | Ponatinib | / | Ariad Pharmaceuticals Inc | US | 2012-12-14 | Neoplasm |
Chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL), leukemia
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-9 | view | Biological Product | / | Vedolizumab | / | Takeda Pharmaceuticals U.S.A., Inc. | US | 2014-05-20 | Gastrointestinal diseases |
Ulcerative colitis, Crohn's disease
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-10 | view | Biological Product | / | Eliglustat | / | Genzyme Corp | US | 2014-08-19 | Endocrine and metabolic disorders |
Gaucher disease
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-11 | view | Biological Product | / | Secukinumab | / | Novartis Pharma K.K. | Japan | 2014-12-26 | Skin/immune system disorders |
Psoriasis, psoriatic arthritis, ankylosing spondylitis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-12 | view | Biological Product | / | Ixekizumab | / | ELILILLYANDCOMPANY | US | 2016-03-22 | Skin/immune system disorders |
Plaque psoriasis, psoriatic arthritis, psoriatic erythroderma, pustular psoriasis, common psoriasis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-13 | view | Biological Product | / | Enasidenib Mesylate | / | CELGENECORP | US | 2017-08-01 | Neoplasm |
Acute myeloid leukemia (AML)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-14 | view | Biological Product | / | Icatibant | / | Shire Orphan Therapies GmbH | EU | 2008-07-11 | Cardiovascular and cerebrovascular diseases |
Hereditary Angioedema (HAE)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-15 | view | Biological Product | / | Dalfampridine | / | Acorda Therapeutics Inc | US | 2010-01-22 | Immune system disorders |
Multiple sclerosis (MS)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-16 | view | Biological Product | / | Vismodegib | / | Genentech Inc | US | 2012-01-30 | Neoplasm |
Basal cell carcinoma
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |