Chinese innovative drugs go global faster in 2021, with marketing applications for eight types accepted by U.S. FDA

Photo taken on Aug. 23, 2021 shows the U.S. Food and Drug Administration in Silver Spring, Maryland, the United States. (Photo by Ting Shen/Xinhua)

BEIJING, Jan. 4 (Xinhua) -- The internationalization of Chinese innovative drugs has been on a faster track in 2021, and the marketing applications for eight Chinese innovative drugs were accepted by the U.S. Food and Drug Administration (FDA), hitting a record high, reported stcn.com.

Among these types, Cilta-cel, developed independently by Legend Biotech, a CAR-T developer in China, is a CAR-T therapy targeting B cell maturation antigen (BCMA). According to Legend Biotech, the review for the Biologic License Application (BLA) of the drug will be completed by the FDA by February 28, 2022. Once authorized, Cilta-cel will become China's first-type CAR-T therapy that enters overseas market and the second-type CAR-T therapy targeting BCMA in the world.

The first domestic PD-1 monoclonal antibody (mAb) is also expected to be granted for marketing in the U.S. in 2022. At present, Innovent Biologics (01801.HK), Shanghai Junshi Biosciences Co.,Ltd. (01877.HK, 688180.SH), BeiGene, Ltd. (06160.HK, 688235.SH), and Akeso, Inc. (09926.HK) have all submitted their BLAs of PD-1 mAb to the FDA.

On February 10, 2022, the FDA will review the New Drug Application (NDA) for Sintilimab of Innovent Biologics. According to the Prescription Drug User Fee Act (PDUFA), the target date for the FDA to make a decision on the marketing application for Tislelizumab of BeiGene, Ltd. is July 12, 2022.

On September 1, 2021, Shanghai Junshi Biosciences Co., Ltd. announced that it had finished the rolling submission of BLA for Toripalimab to the FDA. The BLA submitted by Akeso, Inc. will be reviewed under the Real-Time Oncology Review (RTOR) program of the FDA which can shorten the time required for approval.

In May 2021, the FDA accepted the marketing application for F-627, an innovative drug developed by Yifan Pharmaceutical Co., Ltd. (002019.SZ), and the target approval date for the application is March 30, 2022. In July 2021, the FDA accepted the NDA for Surufatinib, a new drug developed by HUTCHMED (China) Limited (00013.HK) for the treatment of pancreatic neuroendocrine tumors, and the target review date for the application is April 30, 2022.

The FDA is also reviewing the Emergency Use Authorization (EUA) for the novel coronavirus neutralizing antibody BRII-196/BRII-198 combination therapy developed by Brii Biosciences (02137.HK), and the therapy is also hoped to win approval in 2022.

Capital Securities, a comprehensive securities company in China, expects that in the next 5 to 10 years, more domestic drugs will be marketed overseas as Chinese companies have kept making strides in technology, as well as research and development and clinical tests of existing products. The strong payment ability for innovative drugs in overseas markets, especially developed regions such as Europe and the U.S., will bring abundant benefits to domestic companies.