Huadong Medicine Class 1 biopharmaceutical IMGN853 was approved for clinical use

On March 30, the Sino-US East China Class 1 biopharmaceutical IMGN853 (Mirvetuximab Soravtansine), a subsidiary of East China Medicine, was approved for clinical use.

IMGN853 is an antibody-drug conjugate (ADC) targeting FRα developed by ImmunoGen of the United States.

IMGN853 is an antibody-conjugated drug containing FRα (folate receptor) binding antibody, cleavable linker and maytansinoid DM4, which is a powerful tubulin targeting agent.

This product is the world's first ADC drug under development for FRα-positive ovarian cancer.

Both Phase I (IMGN853-0401) and Phase III (IMGN853-0403) studies in the United States have consistently concluded that FRα high-expressing ovarian cancer can benefit from MIRV treatment.

At present, only two imported foreign drugs, Kadcyla and Adcetris, were approved by the NMPA for marketing in January and May 2020 in China.

The IMGN853 clinical approval in China is another progress in the research and development of this new drug.