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 |
| 3-1 | view | Biological Product | / | Caplacizumab | / | Ablynx NV | EU | 2018-09-03 | Circulatory system disorders |
Acquired thrombotic thrombocytopenic purpura (aTTP)
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-2 | view | Chemical Drug | / | Gilteritinib fumarate | / | Astellas Pharma Inc. | Japan | 2018-09-21 | Malignant hematological diseases |
Relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-3 | view | Biological Product | / | Ivosidenib | / | Agios Pharmaceuticals, Inc. | US | 2018-07-20 | Malignant hematological diseases |
Acute myeloid leukemia (AML)
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-4 | view | Biological Product | / | Cerliponase alfa | / | BioMarin Pharmaceutical Inc. | US | 2017-04-27 | Inherited metabolic disorders |
Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2)
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-5 | view | Chemical Drug | Delayed-Release Capsules | Dimethyl fumarate | / | Biogen Idec, Inc. | US | 2013-03-27 | Nervous system disorders |
Multiple sclerosis (MS)
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-6 | view | Chemical Drug | / | Baloxavir Marboxil | / | (Japan) Shionogi & Co., Ltd. | Japan | 2018-02-23 | Infectious diseases |
Influenza A and influenza B flu
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 3-7 | view | Chemical Drug | / | Ciclosporin | / | Santen OY | EU | 2018-07-06 | Eye disorders |
Severe vernal keratoconjunctivitis (VKC) in children from 4 years of age through
adolescence
|
The 3rd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-1 | view | Chemical Drug | Granules | Sapropterin hydrochloride | 10%, 2.5% | Daiichi Sankyo Co., Ltd. | Japan | 2013-08-20 | Endocrine and metabolic disorders |
1. To reduce blood phenylalanine levels in patients with dihydrobiopterin synthetase deficiency and dihydropteridine reductase deficiency in patients with hyperphenylalaninemia (HPA);
2. To reduce blood phenylalanine levels in patients with hyperphenylala
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-2 | view | Biological Product | Injection | Somatropin | / | NOVO NORDISK INC | US | 2007-05-31 | Endocrine and metabolic disorders |
Noonan syndrome
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-2 | view | Biological Product | Injection | Somatropin | / | NOVO NORDISK INC | US | 2018-02-23 | Endocrine and metabolic disorders |
Prader-Willi syndrome (PWS)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |