The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable BBM-H901 has been granted breakthrough therapy designation (BTD) status. The drug is approved for use in preventing bleeding in adult male patients with hemophilia B (congenital factor IX deficiency).
Drug Details
BBM-H901 is a Category 1 biologic and an AAV gene therapy with intellectual property rights. It introduces the human coagulation factor IX (FIX) gene into hemophilia B patients through intravenous administration. This method improves and maintains coagulation factor levels in patients for an extended period.
Clinical Development
The drug initiated an investigator-initiated trial (ITT) in 2019 and obtained clinical trial approval in August 2021. It is the first of its kind to enter a regulatory clinical study in China.-Fineline Info & Tech
