Teruisi announced that the Investigational New Drug (IND) application for the phase 2 trial of TRS005 has been accepted by China's Center for Drug Evaluation (CDE). TRS005 is an antibody-drug conjugate (ADC) targeting CD20, utilizing anti-CD20 antibodies conjugated with MMAE (monomethyl auristatin E) for a more targeted therapeutic approach, with a drug-antibody ratio of 4:2. They have now progressed the candidate to a potential registrational study. TRS005 The single-arm Phase 2 study is aimed at rrDLBCL, with an estimated enrollment of 120-140 participants. The completion of the study may take two years, followed by an additional year for the Biologics License Application (BLA) review. Phase 1 Study Review Meeting The results of the Phase 1 trial in pts with rrNHL after receiving at least 2 standard treatment regimens, initiated in November 2018, were reported in 2022: " From Aug 24, 2020 to Apr 29, 2022, 40 pts received treatment, including 14 pts in dose-escalation pha...
China Biotech XYZ Shares Updates Related to New Drug Development in China