Sept 2022: New Drug Approvals in China

Oct. 12th, 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.

Related Articles:

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
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.]

News Source: ChemLinked

Market | Chemical | Food | Cosmetic | BaiPharm | Agrochemical

REACH24H Consulting Group launched ChemLinked in 2012 as a leading service provider of comprehensive regulatory information and compliance solutions, meeting the growing demand for clear and concise regulatory advice and market intelligence in Asia, especially China.

You can register for a membership to read the latest news limitlessly every day on ChemLinked.