Sept 2022: New Drug Approvals in China
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.
- 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
The approval details are as follows.
1. Edaravone Sublingual Tablet
|1||Generic Name||Edaravone Sublingual Tablet|
|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|
|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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