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.

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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.]

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