New Drug Approvals in China | June 2022
Editor\’s Notes: New drugs in this article refer to
- Innovative/improved new chemical drugs / biological products that have never been granted marketing authorization in or outside China;
- Original/improved chemical drugs / biological products that have received marketing authorization outside China and are applying for marketing authorization in China;
- First generic drugs in China.
*\”First generic drug in China\” refers to the first generic drug developed by Chinese companies and approved by China National Medical Products Administration (NMPA). Technically, generic drugs are not innovative/improved drugs according to Chinese drug regulations. Yet, first generics are still included in this article because they are new in the Chinese market.
In June 2022, China NMPA approved 25 new drugs, including 17 chemical drugs and 8 biological products.
1. Jiangsu Hengrui Pharmaceuticals\’ SHR3680 Tablets;
2. Bayer\’s Finerenone Film-coated Tablets (Kerendia);
3. Qilu Pharmaceutical\’s Aripiprazole Oral Soluble Film;
4. Qilu Pharmaceutical\’s Memantine Hydrochloride Oral Soluble Film;
5. Boehringer Ingelheim\’s Empagliflozin Tablets;
6. Jiangsu Hengrui Pharmaceuticals\’ Pyrotinib Maleate Tablets;
7. Shenzhen China Resources Gosun Pharmaceutical\’s Mitoxantrone Hydrochloride Injection for Tracing;
8. Shanghai Allist Pharmaceuticals\’ Furmonertinib Mesilate Tablets;
9. Hebei Renhe Yikang Pharmaceutical\’s Levetiracetam in Sodium Chloride Injection;
10. Sichuan Baili Pharmaceutical\’s Enalapril Maleate Oral Solution;
11. Chengdu Suncadia Medicine\’s Tacrolimus Extended-release Capsules;
12. Shijizhuang No. 4 Pharmaceutical\’s Blonanserin Tablets;
13. EyePoint Pharmaceuticals\’ Fluocinolone Acetonide Intravitreal Implants (YUTIQ);
14. Basilea Pharmaceutica\’s Isavuconazonium Sulfate for Injection (CRESEMBA);
15. Italfarmaco\’s Riluzole Oral Suspension (TIGLUTIK);
16. Laboratorios Farmaceuticos\’ Bemiparin Sodium Injection;
17. Bayer\’s Larotrectinib Sulfate Oral Solution;
18. CStone Pharmaceuticals\’ Sugemalimab Injection;
19. Akeso Biopharma\’s Cadonilimab Injection;
20. Innovent Biologics\’ Sintilimab Injection (Tyvyt);
21. BeiGene\’s Tislelizumab Injection;
22. BMS\’s Nivolumab Injection;
23. Merck\’s Cetuximab Solution for Infusion (Erbitux);
24. GenSci\’s Recombinant Human Growth Hormone Injection (Jintropin).
25. Gilead Sciences\’ Sacituzumab Govitecan for Injection (Trodelvy).
Details of the approved drugs are listed as follows.
1. SHR3680 Tablets
| 1 | Generic Name | SHR3680 Tablets |
| 2 | Brand Name | / |
| 3 | Registration Classification | Class 1 chemical drug |
| 4 | Application Type | New drug application (NDA) |
| 5 | Marketing Authorization Holder (MAH) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
| 6 | Approval Date | June 30, 2022 |
| 7 | Time from Application Acceptance to Approval | 239 days |
| 8 | Priority Review | Yes (breakthrough therapy) |
| 9 | Target(s) | Androgen receptor |
| 10 | Indication(s) | Indicated for treating metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. |
For details of other drugs, please [read full content].
Reference Links
- China Chemical Drug Registration Classification
- China Biological Product Registration Classification
- China Drug Master Filles (DMF) of APIs, Pharmaceutical Excipients & Packaging Materials
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