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prothrombin complex concentrate (human) (Hebei Da'an Pharmaceutical)
- Development stage
- Approved
- Lead developer
- Hebei Da'an Pharmaceutical
- Administration
- Intravenous
01
Overview
Prothrombin complex concentrate (human) is a human plasma-derived biologic product containing vitamin K-dependent coagulation factors — primarily Factor II (prothrombin), Factor IX, and Factor X, and potentially Factor VII. Developed by Hebei Da'an Pharmaceutical Co., Ltd., it is used to treat hemophilia B (Factor IX deficiency) by replacing the deficient factors and restoring the coagulation cascade. The drug is a 3- or 4-factor prothrombin complex concentrate (PCC) administered by intravenous injection. It is currently being evaluated in a Phase 3, single-arm, open-label clinical trial in China (CTR20180124) to assess its efficacy and safety in treating hemophilia B using an objective performance criterion (target value method).
- Other names
- human prothrombin complexPCC3-factor prothrombin complex concentrate4-factor prothrombin complex concentrate
02
Targets
PROC (Protein C)F9 (Coagulation Factor IX)F2 (Thrombin)F10 (Factor Xa)F7 (Coagulation Factor VII)
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