PLBIO(SZ:000403) Shang Hai Zheng Quan Bao·2025-12-23 20:21Core Viewpoint - The company has received approval for clinical trials of its intravenous immunoglobulin (pH4) after a change in the production process, which is expected to enhance product quality and market competitiveness [1][2]. Group 1: Drug Information - The drug is named intravenous immunoglobulin (pH4) with a dosage form of injection, specified as 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 [1]. Group 2: R&D and Process Improvement - The production process has been upgraded from traditional low-temperature ethanol protein separation to a more advanced method involving caprylic acid precipitation and multi-step chromatography purification, significantly improving product yield and viral safety [2]. - This change aligns the domestic product's manufacturing standards with international practices, enhancing the competitiveness of the company's fourth-generation intravenous immunoglobulin products [2]. Group 3: Approval Process - Following the approval of the clinical trial notification, the company must conduct the clinical research as per the notification and obtain further approval from the National Medical Products Administration before the drug can be marketed [3].