派林生物:全资子公司获静注人免疫球蛋白(pH4)临床试验批准

Core Viewpoint - The announcement indicates that the wholly-owned subsidiary of the company, Guangdong Shuanglin, has received approval from the National Medical Products Administration for clinical trials of a new formulation of intravenous immunoglobulin (pH4) [1] Group 1: Clinical Trial Approval - Guangdong Shuanglin has been granted a Clinical Trial Approval Notice for intravenous immunoglobulin (pH4) [1] - The drug is an injectable formulation with a specification of 2.5g/bottle (5%, 50ml) [1] - The clinical trial aims to evaluate the efficacy and safety of intravenous immunoglobulin (pH4) in treating primary immune thrombocytopenia (ITP) in adults and adolescents through a single-arm, open-label, multicenter study [1]

PLBIO-派林生物:全资子公司获静注人免疫球蛋白(pH4)临床试验批准 - Reportify