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
2-23 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 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 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 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 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 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 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 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 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 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
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings
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