Tu Youyou’s 24-year effort in applying for new drugs

　　Recently, the Institute of Traditional Chinese Medicine of the China Academy of Chinese Medical Sciences submitted a new drug application for additional indications for dihydroartemisinin tablets. The reporter learned from the Municipal Food and Drug Administration that the application has successfully passed the preliminary review of the Municipal Food and Drug Administration and has been forwarded to the State Food and Drug Administration for further approval.

　　It is reported that this is the first application for adding new indications since dihydroartemisinin was approved as a Class I new drug in 1992.

　　Dihydroartemisinin tablets are the result of many years of research by Professor Tu Youyou and are widely valued as a new antimalarial drug.

　　The reporter learned that after dihydroartemisinin was approved as a Class I new drug in 1992, Professor Tu Youyou began to focus on research on the treatment of autoimmune diseases with artemisinin. In research, it was found that dihydroartemisinin tablets also have significant effects on the treatment of lupus erythematosus.

　　According to Wang Manyuan, Tu Youyou’s only doctoral student at the School of Traditional Chinese Medicine at Capital Medical University, the new drug application for increased indications for dihydroartemisinin tablets is to apply for the drug to be used to treat lupus erythematosus.

　　Wang Manyuan said that as early as 2004, Professor Tu had received approval for drug clinical research on additional indications for dihydroartemisinin tablets, “but funding issues have prevented this clinical study from being launched. Without clinical research reports, applications for new drugs or new indications cannot be made.”

　　Wang Manyuan said that dihydroartemisinin tablets can be used to treat lupus erythematosus. In terms of drug production, the pharmaceutical process has not changed much and profits are difficult to guarantee, so no suitable pharmaceutical factory has been found to provide funding.

　　In 2011, Professor Tu won the Lasker Award, and dihydroartemisinin regained attention.

　　“Unfortunately, the drug clinical research approval document applied for at that time had expired. ”Wang Manyuan said.

　　Recently, the Institute of Traditional Chinese Medicine of the China Academy of Chinese Medical Sciences officially submitted an application for new indications for dihydroartemisinin tablets. The State Food and Drug Administration stated that the application complies with the special approval process requirements for new drugs and will speed up its approval process.

　　It is reported that the Drug Registration Office of the Municipal Food and Drug Administration has completed the formal review of the original application materials and transferred them to the Beijing Drug Evaluation Center for technical review on the afternoon of the review day. It has been submitted to the Food and Drug Administration, awaiting further approval.