PLBIO(SZ:000403) Zhi Tong Cai Jing·2025-12-23 09:40Core Viewpoint - Company received approval from the National Medical Products Administration for clinical trials of a new production process for intravenous immunoglobulin (pH4), enhancing product quality and safety [1] Group 1: Clinical Trial Approval - Guangdong Shuanglin Biopharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, has been granted a clinical trial approval notice (No. 2025LP03518) [1] - The approval allows the company to conduct clinical trials for the new production process of intravenous immunoglobulin (pH4) [1] Group 2: Production Process Change - The production process has shifted from traditional low-temperature ethanol protein separation to an internationally mainstream method involving caprylic acid precipitation and multi-step chromatography purification [1] - This change is expected to significantly improve product quality, virus safety, and yield [1] Group 3: Market Competitiveness - The new production process will enhance the safety and convenience of clinical use, aligning domestic product standards with international levels [1] - The upgrade in production technology is anticipated to strengthen the market competitiveness of the company's fourth-generation intravenous immunoglobulin products [1]