Tiantan Biopharma unit gets approval for immunoglobulin drug

Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary, Chengdu Rongsheng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for its supplementary drug application for intravenous human immunoglobulin (pH4) with a specification of 2.5g/bottle (10%, 25ml). The approved drug is indicated for the treatment of primary immunodeficiency syndromes and secondary immunoglobulin G deficiencies. The company invested CNY1,108,790 in research and development. The product still needs to pass GMP compliance inspections before it can be produced and sold. Currently, there are no other intravenous human immunoglobulin (pH4) products with the same specifications on the domestic market. Competitors such as Grifols, Shire and Kedrion manufacture similar products, though with a range of specifications, on the international market.