In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs and 7 are biological products. 1. eVENUS Pharma’s Oteseconazole Capsules (class 1 innovative drug) 2. XZenith Biopharm’s Anaprazole Sodium Enteric-coated Tablets (class 1 innovative drug) 3. Betta Pharma’s Vorolanib Tablets (class 1 innovative drug) 4. Jiangsu Hengrui Pharma’s Retagliptin Phosphate Tablets (class 1 innovative drug) 5. Jiangsu Hansoh Pharma’s Pegmolesatide Injection (class 1 innovative drug) 6. Qilu Pharma’s Iruplinalkib Tablets (class 1 innovative drug) 7. Jiangsu Hengrui Pharma’s Dalpiciclib Isethionate Tablets 8. Immedica Pharma’s Glycerol Phenylbutyrate Oral Liquid 9. Menarini’s Bilastine Tablets 10. Teva Pharmaceutical’s Glatiramer Acetate Injection 11. AstraZeneca’s Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets 12. Neurelis’ Diazepam Nasal Spray 13. Fresenius Kabi’s Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection 14. Recordati Rare Diseases’ Carglumic Acid Dispersible Tablets 15. Shionogi’s Lusutrombopag Tablets 16. Genentech’s Pralsetinib Capsules 17. Ipsen Pharma’s Triptorelin Pamoate for Injection 18. Kelun Industry Group’s ω-3 Fish Oil Medium and Long Chain Fat Emulsion / Amino Acid (16) / Glucose (36%) Injection (first generic) 19. Jincheng Jinsu Pharma’s Amisulpride Oral Solution (first generic) 20. Yangtze River Pharma’s Amlodipine Besilate and Benazepril Hydrochloride Capsules (first generic) 21. Shenzhen Salubris Pharma’s Enarodustat Tablets (first generic) 22. CP Pharma Qingdao’s Calcitriol Oral Solution (first generic) 23. NJCTTQ’s Lubiprostone Soft Capsules (first generic) 24. Hefei Yifan Pharma’s Clofarabine Injection (first generic) 25. Jewim Pharma’s Minoxidil Topical Solution (first generic) ... https://baipharm.chemlinked.com/news/monthly-report-new-drug-approvals-in-china-june-2023
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs and 7 are biological products. 1. eVENUS Pharma’s Oteseconazole Capsules (class 1 innovative drug) 2. XZenith Biopharm’s Anaprazole Sodium Enteric-coated Tablets (class 1 innovative drug) 3. Betta Pharma’s Vorolanib Tablets (class 1 innovative drug) 4. Jiangsu Hengrui Pharma’s Retagliptin Phosphate Tablets (class 1 innovative drug) 5. Jiangsu Hansoh Pharma’s Pegmolesatide Injection (class 1 innovative drug) 6. Qilu Pharma’s Iruplinalkib Tablets (class 1 innovative drug) 7. Jiangsu Hengrui Pharma’s Dalpiciclib Isethionate Tablets 8. Immedica Pharma’s Glycerol Phenylbutyrate Oral Liquid 9. Menarini’s Bilastine Tablets 10. Teva Pharmaceutical’s Glatiramer Acetate Injection 11. AstraZeneca’s Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets 12. Neurelis’ Diazepam Nasal Spray 13. Fresenius Kabi’s Compound Amino Acid (16AA), Glucose (12.6%) and Electrolyte Injection 14. Recordati Rare Diseases’ Carglumic Acid Dispersible Tablets 15. Shionogi’s Lusutrombopag Tablets 16. Genentech’s Pralsetinib Capsules 17. Ipsen Pharma’s Triptorelin Pamoate for Injection 18. Kelun Industry Group’s ω-3 Fish Oil Medium and Long Chain Fat Emulsion / Amino Acid (16) / Glucose (36%) Injection (first generic) 19. Jincheng Jinsu Pharma’s Amisulpride Oral Solution (first generic) 20. Yangtze River Pharma’s Amlodipine Besilate and Benazepril Hydrochloride Capsules (first generic) 21. Shenzhen Salubris Pharma’s Enarodustat Tablets (first generic) 22. CP Pharma Qingdao’s Calcitriol Oral Solution (first generic) 23. NJCTTQ’s Lubiprostone Soft Capsules (first generic) 24. Hefei Yifan Pharma’s Clofarabine Injection (first generic) 25. Jewim Pharma’s Minoxidil Topical Solution (first generic) ... https://baipharm.chemlinked.com/news/monthly-report-new-drug-approvals-in-china-june-2023
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Monthly Report: New Drug Approvals in China | June 2023 | ChemLinked
In June 2023, China NMPA approved 33 new drugs, among which 26 are chemical drugs while 7 are biological products.
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