By Fineline Cube The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE: 300204) STSP-0601 and Johnson & Johnson’s teclistamab are set to receive breakthrough therapy designations (BTDs). STSP-0601 is indicated for on-demand treatment of bleeding in hemophilia A or B patients with inhibitors, while teclistamab targets relapsed or refractory multiple myeloma (MM) patients who have received at least three prior therapies.
Drug Profiles
- STSP-0601: A coagulation factor X activator derived from Viper venom, STSP-0601 specifically activates FX to generate FXa, promoting thrombin generation and hemostasis at the injury site.
- Teclistamab: A bispecific antibody targeting B cell maturation antigen (BCMA) and CD3 receptor on T lymphocytes, teclistamab has previously received BTD in the US and priority status in the EU for MM. Clinical studies show it is well-tolerated at the phase II recommended dose (RP2D, 1500 µg/kg subcutaneously), with significant efficacy.-Fineline Info & Tech