Southern Shuanglin subsidiary gets approval for IVIG clinical trial

Southern Shuanglin Bio-Pharmacy Co., Ltd. announced that its wholly-owned subsidiary, Guangdong Southern Shuanglin Bio-Pharmacy Co., Ltd., received approval from the National Medical Products Administration for a clinical trial. The approval, documented in notification number 2025LP03518, is for the clinical trial of Intravenous Immunoglobulin (pH4) following a production process change.

The approved trial is a single-arm, open, multi-center clinical study to evaluate the efficacy and safety of Intravenous Immunoglobulin (pH4) in adults and adolescents with primary immune thrombocytopenia (ITP). This supplementary application, initially accepted on November 21, 2024, is for a significant upgrade in the manufacturing process.

The new process for Intravenous Immunoglobulin (pH4) shifts from traditional low-temperature ethanol protein separation to an international mainstream caprylic acid precipitation and multi-step chromatography purification. This change is expected to significantly improve product yield, enhance clinical safety and convenience, and boost the company's competitiveness in the market for fourth-generation Intravenous Immunoglobulin products.