China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at addressing bleeding in specific patient groups and preventing and treating bleeding in surgical and invasive operations.
Target Patient Groups for Phase III Study
The Phase III study will focus on the following patient groups:
- Congenital Haemophilia patients with an inhibitor of coagulation factor Ⅷ or Ⅸ greater than 5 Bethesda units (BU).
- Congenital Haemophilia patients expected to have a high memory response to the injection of coagulation factor Ⅷ or coagulation factor Ⅸ.
- Acquired Haemophilia patients.
- Patients with congenital coagulation factor VII (F VII) deficiency.
- Patients with Glanzmann’s thrombasthenia who have platelet membrane glycoprotein Ⅱ b – Ⅲ a (GP Ⅱ b – Ⅲ a)/human leukocyte antigen (HLA) antibodies and who have been or are not effective or poor in platelet transfusion.
Market Landscape and Reimbursement
Currently, only Novo Nordisk’s recombinant human coagulation factor VIIa for injection is registered in China, having entered the National Reimbursement Drug List (NRDL) in 2017. This positions Beijing Tiantan Biological Products as a potential competitor in the market. Meanwhile, Chia Tai Tianqing has completed enrollment for its own Phase III study, indicating a competitive landscape for this critical treatment.-Fineline Info & Tech
