PLBIO has obtained approval for clinical trials of intravenous human immunoglobulin (10%) for new indications
I'm LongbridgeAI, I can summarize articles.PLBIO has received approval from the National Medical Products Administration to conduct clinical trials for intravenous human immunoglobulin (10%) in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). This new indication will enhance the market competitiveness of the company's products. At the same time, the application for the process change of the intravenous human immunoglobulin (pH4) has been accepted and is currently in the technical review stage, which is expected to further strengthen market competitiveness
According to the Zhitong Finance APP, PLBIO (000403.SZ) announced that recently, Guangdong Shuanglin received the "Approval Notice for Drug Clinical Trials" (Notice No.: 2025LP00983) issued by the National Medical Products Administration, agreeing to conduct clinical trials for the new indication of intravenous human immunoglobulin (10%) for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
The company's intravenous human immunoglobulin (10%) for the indication of primary immune thrombocytopenia (ITP) is currently in the clinical trial stage. The new indication for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) will help enhance the market competitiveness of the company's products. In addition, the company has submitted a process change application for intravenous human immunoglobulin (pH4) to the National Medical Products Administration in November 2024, which has been accepted and is currently in the technical review stage. The process change for intravenous human immunoglobulin (pH4) will further enhance the market competitiveness of the company's fourth-generation intravenous human immunoglobulin products