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Monthly Report: New Drug Approvals in China | September 2023
In Sept. 2023, China NMPA approved 19 new drugs, among which 12 are chemical drugs and 7 are biological products:
1. Luye Life Sciences’ Goserelin Microspheres for Injection
2. HRA Pharma Rare Diseases’ Mitotane Tablets
3. N.V. Organon’s Ezetimibe and Atorvastatin Calcium Tablets
4. Napp Pharmaceuticals’ Fluticasone Propionate and Formoterol Fumarate Aerosol for Inhalation
5. Sinotau Pharmaceuticals’ Florbetaben [¹⁸F] Injection (Ouweining)
6. Grand Pharma’s Carglumic Acid Dispersible Tablets (Anweide)
7. CSPC Ouyi Pharmaceutical’s Irinotecan Hydrochloride Liposome Injection
8. Qilu Pharmaceutical’s Dolutegravir Sodium Tablets
9. Gowell Pharma’s ω-3 Fish Oil Fat Emulsion Injection
10. Acebright Pharma’s Neratinib Maleate Tablets
11. Brilliant Pharmaceuticals’ Dacomitinib Tablets
12. Grand Life Sciences’ Etomidate Injectable Emulsion
13. Shanghai JMT-Bio Technology’s Narlumosbart Injection
14. Henlius’ Serplulimab Injection (Hansizhuang)
15. Eli Lilly’s Insulin Lispro Injection (Youmile)
16. Sanofi’s Dupilumab Injection (Dupixent)
17. Eli Lilly’s Dulaglutide Injection (TRULICITY)
18. MSD’s Pembrolizumab Injection (Keytruda)
19. Novartis’ Erenumab Injection (Aimovig)
Oct 09, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | June 2023
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
Jul 07, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
COVID-19
Monthly Report: New Drug Approvals in China | January 2023
In January 2023, China NMPA approved 15 new drugs, including 8 chemical drugs and 7 biological products. Simcere's Simnotrelvir Tablets / Ritonavir Tablets and Shanghai Vinnerna Biosciences' Deuremidevir Hydrobromide got conditional approvals for COVID-19 treatment.
Feb 03, 2023
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Diabetes
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | September 2022
In September 2022, China NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.
Oct 08, 2022
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