A Review of Chinese-produced Class 1 New Drugs from 2018 to 2020

From 2018 to 2020, the marketing of Chinese-produced Class 1 new drugs entered the harvest period, with a total of 32 marketed (Chinese-produced Class 1 new drugs here refer to drugs registered under the classification of chemical drugs 1 and therapeutic biological products 1; preventive biological products and traditional Chinese medicines are not included in the statistics).

Chinese-produced Class 1 New Drugs Marketed in 2018

 (Source: NMPA)

Chinese-produced Class 1 New Drugs Marketed in 2019

 (Source: NMPA)

Chinese-produced Class 1 New Drugs Marketed in 2020

 (Source: NMPA)

From the perspective of years, nine Class 1 new drugs were approved both in 2018 and 2019, and the number exploded in 2020 to reach 14.

From the perspective of R&D companies, from 2018 to 2020, Hengrui had the most Class 1 new drugs approved, with four, namely, pyrotinib maleate, camrelizumab, fluzoparib, and remimazolam tosylate, followed by Hansoh, with three approved, namely, polyethylene glycol loxenatide, flumatinib, and almonertinib. BeiGene, Ascletis, and Hutchison MediPharma all had two approved, and the rest had only one. There’s no doubt that Hengrui is still the leading innovative drug enterprise in China.

From the perspective of the approved indications, nearly half of the 32 Class 1 new drugs are oncology drugs, followed by anti-infectives and anesthetics, therefore, oncology drugs are still the top priority in the R&D of Chinese-produced Class 1 new drugs. And if you are looking for anesthesia distributors, then Pharmasources would be your best choice.

From the perspective of targets, among the 32 Class 1 new drugs approved, those against the PD-1 target were the most, with a total of four anti-PD-1 drugs approved in these three years, followed by separately two against PARP, BTK, and NS5A, which shows that Chinese-produced innovative drugs are more and more advancing with the times, and the R&D targets are getting more and more in line with international standards or even synchronized.

The value of a drug ultimately needs to be judged by the market. Among the 32 Chinese-produced Class 1 new drugs marketed, the best-selling ones are anti-PD-1 drugs and Chiatai Tianqing’s anlotinib. Anlotinib is already a blockbuster drug with annual sales of about RMB3 billion. And Hengrui’s anti-PD-1 drug camrelizumab has annual sales of more than RMB 1 billion; anti-PD-1 drugs of Junshi and Innovent: toripalimab and sintilimab both have annual sales of more than RMB 500 million.

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.