PharmaSources/caicaiJanuary 21, 2019
Tag: new drugs , Approved , 2018 , Chinese-produced Drugs
Chinese-produced New Drugs Approved for Marketing in 2018:
(Source: NMPA website, company announcements)
Pharmaceutical product name | Trade name | Registration classification | Company | Approval date | Indication |
Recombinant Cytokine Gene Derived Protein Injection | Novaferon | Biological product for treatment 1 | Genova Inc. | Apr. 20, 2018 | HBV |
Anlotinib Hydrochloride Capsules | FOCUS V | Chemical drug 1 | Chiatai Tianqing | May 17, 2018 | Locally advanced or metastatic NSCLC |
Mecapegfilgrastim Injection | Aiduo | Biological product for treatment 9 | Hengrui Medicine | May 17, 2018 | Neutropenia |
Albuvirtide for Injection | Aikening | Chemical drug 1 | Frontier Biotechnologies | May 30, 2018 | HIV-1 |
Danoprevir Sodium Tablets | Ganovo | Chemical drug 1 | Ascletis | June 15, 2018 | HCV |
Pegylated Recombinant Interferon Variant Injection | Kailiwei | Biological product for treatment 9 | Beijing Kawin | July 6, 2018 | HCV |
Pyrotinib Maleate Tablets | Airuini | Chemical drug 1 | Hengrui Medicine | Aug. 17, 2018 | Human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer |
Fruquintinib Capsules | Elunate | Chemical drug 1 | Hutchison MediPharma | Sep. 13, 2018 | Colorectal cancer |
Toripalimab Injection | Tuoyi | Biological product for treatment 1 | Junshi Biosciences | Dec. 21, 2018 | Melanoma |
Sintilimab Injection | Tyvyt | Biological product for treatment 1 | Innovent | Dec. 27, 2018 | Classical Hodgkin's lymphoma |
Jinrong Xiaopi Granules | / | TCM 6.1 | Kangyuan Pharmaceutical | Dec. 27, 2018 | Cyclomastopathy: intermingled phlegm and blood stasis and disharmony of the thoroughfare and conception vessels |
Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.
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