Phase III clinical trial of Tian Tan Biological’s intravenous injection of human immunoglobulin for new indications
July 22, 2025
Source: drugdu
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On the evening of July 17th, Tiantan Biotechnology disclosed an announcement on the progress of clinical trials for its subsidiary companies' drugs.
According to the announcement, Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of the company, has completed clinical ethics review and pre enrollment preparations for the newly added indication of chronic inflammatory demyelinating polyneuropathy in its marketed product "Intravenous human immunoglobulin (pH4)" (10%, 50ml). The Phase III clinical trial has been officially launched recently.
This new indication is the first clinical study in China to approve the use of intravenous immunoglobulin products for the indication of chronic inflammatory demyelinating polyneuropathy. The main procedures required for the approval of new indications for the above-mentioned products include completing phase III clinical trials, submitting a new indication permit application, and obtaining approval for new indications after being reviewed by the Drug Evaluation Center of the National Medical Products Administration and approved by the National Medical Products Administration. (Zhao Jingwen)
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