On July 1, 2020, the latest Drug Registration Regulations were enacted. This new set of regulations introduced four accelerated procedures for BTDs therapy, conditional approval, priority review and approval, and special approval.
As a weathervane of China Biotech, CES HK Biotechnology Index (CES HK Biotech) roseby 9.51% in January, By comparison, A-shares of the China Securities Medicine Index has been rising at 5.02%, the Shanghai and Shenzhen 300 Index had a growth rate at 2.7% and the Hang Seng Index (HSI) had a 3.87% growth.
Now, oncology is the hot field in drug development. Therefore, the CDE wants to guide clincial development through the document, emphasis the concept of clincial value-oriented, and implement the ICH PFDD guidelines through the document.
Its nonsteroidal antiandrogen candidate proxalutamide reduced mortality risk by 92% and shortened the median length of hospital stays by nine days, according to an investigator-initiated trial conducted in Brazil.