Chengdu Rongsheng, a subsidiary of Tiantan Biological holding company, obtained the clinical approval of human immunoglobulin

Approval for clinical trials of drugs Tiantan Biology (SH: 600161): Announcement on the holding subsidiary's obtaining approval for clinical trials of drugs Chengdu Rongsheng Pharmaceutical Co., Ltd., a holding subsidiary of Beijing Tiantan Biological Products Co., Ltd (hereinafter referred to as Chengdu Rongsheng), recently obtained approval for clinical trials of drugs issued by the State Food and drug administration, The details are as follows: 1 Product overview the product involved in the approval for clinical trial of drugs is intravenous immunoglobulin (pH4, 10%) (chromatography) The product is based on Chengdu Rongsheng intravenous immunoglobulin (pH4), and the production process, formula and other improved products have been improved in terms of quality standard, product yield and virus safety The main approval procedures to be performed before the production and marketing of the product include: completing the clinical trial, applying for production and obtaining the production registration approval The details of related products and approvals are as follows: Company Name: Chengdu Rongsheng Pharmaceutical Co., Ltd drug name: intravenous injection of human immunoglobulin (pH4, 10%) (chromatography) drug indications: 1 Treatment of primary immunoglobulin G deficiency, such as X-linked hypoimmunoglobulinemia, common variant immunodeficiency, immunoglobulin G subclass deficiency, etc; 2 Treatment of secondary immunoglobulin G deficiency diseases, such as severe infection, neonatal septicemia, bronchiolitis in infants, etc.; 3 Treatment of autoimmune diseases, such as primary thrombocytopenic purpura, Kawasaki disease, etc Specification: 10% 50ml5g / bottle dosage form: injection registration classification: time and acceptance number of the first clinical trial application of biological products for treatment: 2014 cysb1400185 Sichuan cumulative R & D investment (10000 yuan): 1537.5 approval opinion: according to the drug management law of the people's Republic of China and relevant regulations, the product meets the relevant requirements of drug registration after examination, Approve the product for clinical trial 2、 At present, there are no domestic products of the above drugs on the market Situation of imported products: the company does not know the situation of similar drugs of other manufacturers in foreign market 3、 Risk indicates that the research and development of drugs is a long-term work, and there are many internal and external uncertainties Please pay attention to the investment risk