- 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.
- China Chemical Drug Registration Classification
- China Biological Product Registration Classification
- Expedited Programs for Drug Registration in China
In September 2022, China's NMPA approved 16 new drugs, including 12 chemical drugs and 4 biological products.
- Nanjing Biosnwill Medical's Edaravone Sublingual Tablet
- AstraZeneca's Dapagliflozin Tablets
- Bayer's Rivaroxaban Tablets
- AstraZeneca's Olaparib Tablets
- Yichang Humanwell Pharmaceutical's Clobazam Tablets
- Jiangxi Yiyou Pharmaceutical's Bromhexine Hydrochloride Granules
- Qilu Pharmaceutical's Aprepitant Injection
- Hainan Poly Pharm's Terlipressin Injection
- Inner Mongolia Baiyi Pharmaceutical's Compound Vitamins (13) for Injection
- Staidson's Polyethylene Glycol Electrolytes Oral Solution
- Staidson's Polyethylene Glycol Electrolytes Powder
- Kelun Pharmaceutical's Ceftriaxone Sodium for Injection and Sodium Chloride Injection
- CStone Pharmaceuticals' Sugemalimab Injection
- Lepu Biopharma's Pucotenlimab Injection
- Shanghai Junshi Biosciences' Toripalimab Injection
- Novartis' Omalizumab Injection
1. Edaravone Sublingual Tablet
| 1 | Generic Name | Edaravone Sublingual Tablet |
| 2 | Brand Name | / |
| 3 | Classification | Class 2.2 chemical drug |
| 4 | Application Type | New drug application (NDA) |
| 5 | Marketing Authorization Holder (MAH) | Nanjing Biosnwill Medical Co., Ltd. |
| 6 | Approval Date | Sept. 19, 2022 |
| 7 | Time from Application Acceptance to Approval | 422 days |
| 8 | Priority Review | No |
| 9 | Target(s) | / |
| 10 | Indication(s) | Indicated for inhibiting the progression of dysfunctions caused by amyotrophic lateral sclerosis (ALS). |
2. Dapagliflozin Tablets
[More details of the new drugs are available on BaiPharm.]
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