Tags : NMPA

Regulatory

Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML

Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS, mOS (9.3 vs 5.6mos.) Additionally, Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR […]Read More

Regulatory

Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China

Shots: The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no […]Read More

Regulatory

Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent

Shots: The NMPA has approved Byvasda for the treatment of adult recurrent Glioblastoma which is the third approved indication of Byvasda in China The launch of Byvasda has provided Chinese patients with high quality and relatively more affordable bevacizumab biosimilar injection Byvasda is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Byvasda […]Read More