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 |
2-23 | view | Biological Product | / | Edaravone | / | Mitsubishi Tanabe Pharma Corporation | Japan | 2015-06-01 | Nervous system disorders |
Amyotrophic lateral sclerosis (ALS)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
2-24 | view | Biological Product | / | Vigabatrin | / | Lundbeck Inc. | US | 2009-08-21 | Nervous system disorders |
For pediatric patients with infantile spasms (IS) 1 month to 2 years of age; for adults and pediatric patients 10 years of age and older with refractory complex partial seizures (CPS)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
2-25 | view | Biological Product | Injection | Dupilumab | / | Regeneron Pharmaceuticals, Inc. | US | 2017-03-28 | Skin disorders |
Moderate-to-severe atopic dermatitis
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
2-26 | view | Biological Product | Ointment | Crisaborole | / | Anacor Pharmaceuticals, Inc. | US | 2016-12-14 | Skin disorders |
Topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 2 years of age and older
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-1 | view | Biological Product | / | Siltuximab | / | Janssen Biotech, Inc. | US | 2014-04-23 | Immune system disorders |
Multicentric Castleman disease (MCD)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-2 | view | Biological Product | / | Elosulfase alfa | / | Biomarin Pharmaceutical Inc. | US | 2014-02-14 | Endocrine and metabolic disorders |
Mucopolysaccharidosis TypeⅣA
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-3 | view | Biological Product | / | Selexipag | / | Actelion Pharmaceuticals Ltd | US | 2015-12-21 | Respiratory system disorders |
Pulmonary hypertension
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-4 | view | Biological Product | / | Brodalumab | / | Kyowa Hakko Kirin Co., Ltd. | Japan | 2016-07-04 | Skin/immune system disorders |
Common psoriasis, psoriatic arthritis, psoriatic erythroderma, pustular psoriasis, plaque psoriasis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-5 | view | Biological Product | / | Canakinumab | / | Novartis Pharmaceuticals Corporation | US | 2009-06-17 | Immune system disorders |
Systemic juvenile idiopathic arthritis (JIA), cryopyrin-associated periodic syndrome (CAPS), hyper-IgD syndrome (HIDS), familial mediterranean fever (FMF), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), arthritis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
1-6 | view | Biological Product | / | Denosumab | / | Amgen Europe B.V. | EU | 2010-05-26 | Neoplasm |
Bone mtastasis from solid tumors, bone cancer, solid tumor, giant cell tumour of bone, multiple myeloma (MM), hypercalcemia, rheumatoid arthritis (RA), osteoporosis
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The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |