Research on the development strategies of new antineoplastic agents: An analysis based on the comparison of new drugs launched in China, America and Japan

Corresponding author: HAN You-li, hanyouli@ccmu.edu.cn

DOI: 10.12201/bmr.202106.00021

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  Abstract: Objective: Based on the listing of new drugs in China, the United States and Japan, this article summarized the current development status and problems of new antineoplastic agents in China and put forward policy recommendations on improving domestic antineoplastic agents innovation and development policies. Methods: This article combed the definition of “new drugs” in China, the United States and Japan. Based on the new drug listing data in various countries in 2019, the types of new drugs listed, the original research manufacturers, the indications and timeliness of listed antineoplastic agents were compared and analyzed. Results: China’s pharmaceutical research and development capabilities have improved significantly, but its international influence still needs to be improved. In 2019, China’s number of new drugs approved for marketing surpassed those of the United States and Japan, but we still lagged behind the others in the timeliness of marketed antineoplastic agents; We still need to continuously improve policies and regulations to promote the development of new antineoplastic agents. Conclusion: We need to provide policy support and guidance from the whole process of the development and production of new antineoplastic agents, encourage companies to increase investment in research and development. At the same time, we still need to focus on improving the drug examination and approval system, and ultimately achieve patient access and continuous innovation.

  Key words: Antineoplastic agents; Drug examination and approval; Drug innovation

  Submit time: 8 October 2021

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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