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 |
| 2-3 | view | Biological Product | / | Burosumab | / | Kyowa Kirin Limited | EU | 2018-02-19 | Endocrine and metabolic disorders |
X-linked hypophosphatemia (XLH)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-4 | view | Biological Product | Injection | Mecasermin (rDNA origin) | / | IPSEN INC | US | 2005-08-30 | Endocrine disorders |
1. Severe primary insulin-like IGF1 deficiency in children; 2. Genetic disorders of the GH receptor; 3. Growth hormone (GH) gene deletion due to the development of neutralizing antibodies to GH.
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-5 | view | Biological Product | / | Laronidase | / | BIOMARIN PHARMACEUTICAL INC. | US | 2003-04-30 | Inherited metabolic disorders |
Mucopolysaccharidosis I (MPS I)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-6 | view | Biological Product | Injection | Indursulfase | / | Shire Human Genetic Therapies, Inc. | US | 2006-07-24 | Inherited metabolic disorders |
Mucopolysaccharidosis II (MPS II)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-7 | view | Biological Product | / | Agalsidase Beta | / | Genzyme Europe B.V. | EU | 2001-03-08 | Inherited metabolic disorders |
Fabry disease
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-8 | view | Biological Product | / | Agalsidase alfa | / | Shire Human Genetic Therapies AB | EU | 2001-03-08 | Inherited metabolic disorders |
Fabry disease
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-9 | view | Chemical Drug | / | Migalastat hydrochloride | / | Amicus Therapeutics UK Ltd | EU | 2016-05-25 | Inherited metabolic disorders |
Fabry disease
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-10 | view | Biological Product | / | Apalutamide | / | Janssen Biotech, Inc. | US | 2018-02-14 | Neoplasm |
Non-metastatic castration-resistant prostate cancer (nmCRPC)
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-11 | view | Chemical Drug | / | Mitotane | / | HRA Pharma | US | 1970-07-08 | Neoplasm |
Adrenal cortical carcinoma
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |
| 2-12 | view | Biological Product | / | Coagulation Factor IX (Recombinant), Fc Fusion Protein | / | Bioverativ Therapeutics Inc | US | 2014-03-28 | Circulatory system disorders |
Hemophilia B
|
The 2nd Batch of Overseas New Drugs Urgently Needed in Clinical Settings |