BTBP(SH:600161) Zheng Quan Zhi Xing·2025-07-17 08:12Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. has announced the initiation of a Phase III clinical trial for its product "Intravenous Human Immunoglobulin (pH4)" for the newly added indication of chronic inflammatory demyelinating polyneuropathy, marking a significant development in the company's product pipeline [1][2]. Group 1: Product Information - The product "Intravenous Human Immunoglobulin (pH4)" is classified as a therapeutic biological product, with a specification of 5g per bottle and a dosage form of injection [1]. - The clinical trial approval for the new indication was granted on September 11, 2024, under notification number 2024LP02047 [1]. - The product has a total investment of 185.208 million yuan in its development [1]. Group 2: Market Situation - This new indication represents the first clinical research approval for an intravenous human immunoglobulin product in China for chronic inflammatory demyelinating polyneuropathy [2]. - The international market features several competitors, including CSL Behring, Grifols, and Octapharma, offering various specifications and forms of intravenous immunoglobulin products [3].