Sept 2022: New Drug Approvals in China

Oct. 12th, 2022
2515

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.

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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


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