SINO BIOPHARM(HK:01177) Zheng Quan Ri Bao Wang·2025-07-03 10:47Core Viewpoint - The approval of the recombinant human coagulation factor VIIa (N01) by China National Medical Products Administration marks a significant advancement in treatment options for hemophilia patients with inhibitors, providing a domestically developed solution for this rare genetic disorder [1][2]. Company Summary - China National Pharmaceutical Group's subsidiary, Chengdu Kanghong Pharmaceutical Group Co., Ltd. (referred to as "Kanghong"), has developed the first domestically approved recombinant human coagulation factor VIIa product, named Anqixin, specifically for adult and adolescent hemophilia patients with inhibitor levels greater than 5 Bethesda units [1]. - Anqixin is the only domestic recombinant human coagulation factor VIIa confirmed for efficacy and safety through Phase III clinical trials, which included 60 participants and demonstrated a hemostatic efficacy rate of 88.93% across 551 evaluable bleeding events [2]. Industry Summary - Hemophilia is categorized into Type A (factor VIII deficiency) and Type B (factor IX deficiency), with no current cure available. The primary treatment involves exogenous factor replacement therapy, but approximately 4% of patients develop inhibitors that complicate treatment [2]. - The global hemophilia patient population is estimated at around 830,000, highlighting the significant market potential for effective treatments like Anqixin [1]. - The combination of Anqixin with previously developed recombinant human coagulation factor VIII (Anhengji) allows for comprehensive treatment options covering both routine replacement therapy and inhibitor management, potentially benefiting a broader range of hemophilia patients [3].