Shanghai Raas Blood Products Co.,Ltd. (002252.SZ) has announced that its investigational drug, SR604 Injection, has been listed on the National Medical Products Administration's drug clinical trial registration and information disclosure platform for a Phase III clinical trial focused on the preventive treatment of bleeding episodes in patients with hemophilia A or B.
The trial is designed as a single-arm, multicenter study to evaluate the efficacy and safety of SR604 Injection in prophylaxis for hemophilia A or B patients, both with and without inhibitors, with the primary objective of assessing its effectiveness in preventing bleeding episodes.
Building on earlier exploration of multiple dosing regimens and administration intervals for SR604 Injection in hemophilia A and B, the company is now initiating this confirmatory Phase III study, which plans to test a repeated dosing schedule of 0.4 mg/kg administered once every four weeks. If the product is successfully developed, it has the potential to significantly improve the treatment experience for patients living with hemophilia A or B.
As of the date of this announcement, no product targeting the same biological pathway as this drug has been approved or launched globally.