Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Hexvix (APL-1706) for the diagnosis and management of bladder cancer.
Hexvix stands as the only globally approved agent for aiding in the diagnosis or surgery of bladder cancer and has been shown to significantly enhance the detection rate of non-muscle invasive bladder cancer (NMIBC) when used in conjunction with blue light cystoscopy. A Phase III clinical study demonstrated that the combination of APL-1706 with a blue light cystoscope (BLC) improved the detection rate of bladder cancer compared to the standard white light cystoscope.- Flcube.com
