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human immunoglobulin (pH 4) for intravenous injection
- Development stage
- Phase 3
- Lead developer
- Grand Shuyang Life Sciences
- Modality
- Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
Human immunoglobulin (pH 4) for intravenous injection is a plasma-derived biologic product developed by Grand Shuyang Life Sciences (Chengdu) Co., Ltd. It is a polyclonal antibody preparation consisting of concentrated Immunoglobulin G (IgG) pooled from healthy human plasma donors. The product provides passive immunity by supplementing antibody levels in patients with primary or secondary immunodeficiency diseases, such as X-linked hypoimmunoglobulinemia and neonatal sepsis. It is also utilized to modulate immune responses in autoimmune conditions, including Primary Immune Thrombocytopenia (ITP). The formulation is stabilized at pH 4 to maintain protein integrity and minimize the formation of aggregates, ensuring safety and efficacy during intravenous administration. Grand Shuyang recently commissioned a fourth-generation production line for this product, designed to meet EU GMP standards.
- Brand names
- SUYA-IV
- Other names
- 5% IVIGhuman intravenous immunoglobulinhuman immunoglobulin (pH4) for intravenous injection
02
Targets
FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)
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