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 |
| 1-27 | view | Biological Product | / | Sonidegib | / | NovartisPharmaceuticalsCorp | US | 2015-07-24 | Neoplasm |
Basal cell carcinoma
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-28 | view | Biological Product | / | Olaratumab | / | Eli Lilly and Company | US | 2016-10-19 | Neoplasm |
Soft tissue sarcoma
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-29 | view | Chemical Drug | / | Nusinersen | / | BIOGENIDECINC | US | 2016-12-23 | Musculoskeletal System Disorders |
Spinal muscular atrophy
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-30 | view | Biological Product | / | Deutetrabenazine | / | TEVABRANDEDPHARM | US | 2017-04-03 | Musculoskeletal System Disorders |
Tardive dyskinesia, Huntington's disease (HD)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-31 | view | Biological Product | / | Dinutuximab Beta | / | EUSA Pharma (UK) Limited | EU | 2017-05-08 | Neoplasm |
Neuroblastoma
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-32 | view | Biological Product | / | Cenegermin | / | Dompe farmaceutici s.p.a. | EU | 2017-07-06 | Eye disorders |
Keratitis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-33 | view | Biological Product | / | Guselkumab | / | JANSSENBIOTECH | US | 2017-07-13 | Skin/immune system disorders |
Psoriatic erythroderma, plaque psoriasis, pustular psoriasis, psoriatic arthritis, common psoriasis
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-34 | view | Biological Product | / | Vestronidase alfa | / | ULTRAGENYXPHARMINC | US | 2017-11-15 | Endocrine and metabolic disorders |
Mucopolysaccharidosis Type VII
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-35 | view | Biological Product | / | Zoster vaccine recombinant, adjuvanted | / | GlaxoSmithKline Biologicals Rue de l"Institut 89, B1330 Rixensart, Belgium Lic # 1617 | US | 2017-10-20 | Infectious diseases |
Varicella-zoster virus (VZV) (for adults aged over 50)
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 1-36 | view | Chemical Drug | / | Voretigene neparvovec | / | Spark Therapeutics, Inc. 3737 Market Street, Suite 1300, Philadelphia, PA, 19104 Lic# 2056 | US | 2017-12-19 | Eye disorders |
Biallelic RPE65 mutation-associated retinal dystrophy
|
The 1st Batch of Overseas New Drugs Urgently Needed in Clinical Settings |