By Fineline Cube 
China’s Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human coagulation factor VIIa N01. The drug is indicated for the treatment of bleeding episodes in congenital hemophilia patients aged 12 and above with factor VIII or IX inhibitors >5 Bethesda units (BU). This approval makes it the first home-grown biologic product of its kind in China.
Clinical Trial Results
The NMPA’s approval is supported by results from a multi-center Phase III study conducted in hemophilia patients with inhibitors. The study involved 60 subjects and covered 559 bleeding episodes. Among 551 evaluable bleeding events, the drug demonstrated an effective hemostasis rate of 88.93%. Developed through independently established cell culture, separation and purification, and formulation processes, the drug has obtained two Chinese invention patents and has undergone multiple batches of commercial production validation, ensuring consistent quality.
Complementary Product Launch
The launch of recombinant human coagulation factor VIIa N01 complements Sino Biopharmaceutical’s previously approved recombinant human coagulation factor VIII (An Heng Ji). Together, these products address the full spectrum of treatment needs for hemophilia patients, from routine replacement therapy to inhibitor management, potentially benefiting a broader population of patients.-Fineline Info & Tech