UB514
ProductIV Human Immunoglobulin (pH4) for Intravenous Injection
Strength1.25mg, 2.5mg, 5mg
IndicationsX-linked agammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G subclass deficiency; Neonatal sepsis; Idiopathic thrombocytopenic purpura; Kawasaki disease
TherapeuticsImmunology & Inflammation
GMPCN - NMPA
RegistrationChina
ModalitiesProtein
Exclusive Summary
- Superior Quality Profile: 99.2% purity and 99.3% monomer/dimer content, significantly exceeding national pharmacopeia standards.
- Enhanced Safety: Extremely low PKA levels (<10 IU/ml) minimize the risk of transfusion-related hypotension, offering a safety advantage over standard competitors.
- Reliable Supply Chain: Sourced from 21 plasma stations with >1000 donors per batch, ensuring broad antibody diversity and stable supply for global shortages.
Asset Materials
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