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:

• 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

2. Dapagliflozin Tablets

[More details of the new drugs are available on BaiPharm.]