For Patients

Understand the study objectives and risks and sign informed consent forms according to national and local privacy laws;

Males subjects and ≥ 18 years of age;

Meet the requirements for detecting endogenous FVIII activity levels;

Have had ≥150 prior exposure days (EDs) to any recombinant and/or plasma-derived FVIII protein products;

Subjects for prophylaxis: people who need at least three times of exogenous FVIII treatment for hemorrhagic attack in the past 52 weeks (spontaneous or traumatic)

No history of hypersensitivity or anaphylaxis associated with FVIII product administration;

Have no measurable FVIII inhibitor as assessed by laboratory two times that were at least one week apart; or documented no prior history of FVIII inhibitor after 150 EDs and no clinical signs or symptoms of decreased response to FVIII infusion;

Have acceptable laboratory values of hematology, kidney function, liver function and blood coagulation function sampled at screening and repeated prior to Day 0;

Agree to use reliable barrier contraception until the end of the observation period and laboratory test when required;