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 July 2022, China NMPA approved 10 new drugs, including 8 chemical drugs and 2 biological products. Among the drugs, Genuine Biotech’s Azvudine Tablets is the first homegrown oral drug to get NMPA’s approval for COVID-19 treatment.

1. Genuine Biotech’s Azvudine Tablets
2. Haisco Pharmaceutical’s Ciprofol Injection
3. Yichang Humanwell Pharmaceutical’s Remimazolam Besylate for Injection
4. Xiamen LP Pharmaceutical’s Clonidine Hydrochloride Sustained-release Tablets
5. Anbison Lab’s Carbamazepine Sustained-release Tablets (II)
6. G1 Therapeutics’ Trilaciclib for Injection
7. Roche’s Entrectinib Capsules
8. Toray Industries’ Beraprost Sodium Sustained-Release Tablets
9. Lepu Biopharma’s Pucotenlimab Injection

10. Eli Lilly’s Ixekizumab Injection

Details of the new drugs are available on BaiPharm.

Reference Links

• New Drug Approvals in China | June 2022
• Webinar: Generic Drug Application Procedures in China
• Generic Drug Application (ANDA) in China
• H1 2022: Top 12 China Generic Drug Approval Winners

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