China's first self-developed precharged yisaipu water needle submitted a new drug production application and was accepted

July 29, 2019 / Meitong news agency / -- China's leading biopharmaceutical company Sansheng Pharmaceutical Co., Ltd announced that the pre filled yisaipu (general name: recombinant human type II tumor necrosis factor receptor antibody fusion protein injection), an antibody fusion protein drug product independently developed by Sansheng Guojian Pharmaceutical (Shanghai) Co., Ltd., has submitted the new drug production to the State Drug Administration Application and acceptance This pre filled yisaipu ® water injection is the first self-developed pre filled fusion protein injection in China It is used for the treatment of three indications: active ankylosing spondylitis, moderate and severe active rheumatoid arthritis, and moderate and severe plaque psoriasis in adults aged 18 and over According to the research, the prevalence of these three diseases in China is about 0.3% 1, 0.4% 2 and 0.1% 3 respectively At present, patients' compliance with the use of biological agents is not ideal The poor compliance of patients with medication is also one of the important reasons for the recurrence of the disease This precharged yisaipu ® water injection has achieved a major breakthrough in the domestic biological medicine preparation technology, so that patients are no longer limited to hospital treatment, but can inject themselves at home, which is expected to greatly improve patients' drug compliance and improve their quality of life Yisaipu ® was launched into the market in 2006 So far, it has benefited more than 300000 patients, gained professional recognition and extensive patient trust from clinicians, and was included in class B drugs in the national medical insurance catalog in 2017 Pre filled yisaipu ® water injection will bring more dosage form options, which is expected to benefit more patients Dr Lou Jing, chairman and chief executive officer of Sansheng pharmaceutical, said: "it's nice to see the application for new drug production of pre filled yisaipu ® water injection successfully submitted Sansheng pharmaceutical will continue to focus on the field of Biopharmaceutics, to explore and develop more therapeutic biopharmaceuticals of different dosage forms to meet different medical needs and provide more choices for patients " Data sources: 1 2012 Chinese Journal of orthopaedics 2 2018 China rheumatoid arthritis diagnosis and treatment guide 3 2018 China psoriasis diagnosis and treatment guide about ISEP ® Yisaipu ® (rhTNFR: FC), a recombinant human type II tumor necrosis factor receptor antibody fusion protein injection, targets TNF - α, a major inflammatory mediator in the pathological process of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis It can be combined with TNF - α, inhibit the biological activity of TNF - α, so as to achieve the therapeutic effect Using recombinant DNA technology, yisaipu constructed eukaryotic expression vector with fusion gene of human tumor necrosis factor II receptor (p75) extracellular coding region and human igg1fc coding region, and transfected Chinese hamster ovary cell (cho-k1cell) to express rhTNFR: FC efficiently About Sansheng Guojian Pharmaceutical (Shanghai) Co., Ltd (referred to as "Sansheng Guojian") under Sansheng Guojian pharmaceutical was established in 2002 Sansheng Guojian focuses on the R & D, pilot test and industrialization of antibody drugs The company has the only "National Engineering Research Center for antibody drugs" (approved by the national development and Reform Commission) in China, and operates the largest production base of monoclonal antibody with the highest level of technological advancement in China, with a production capacity of more than 38000 liters Sansheng Guojian is the pioneer of antibody drugs in China and the absolute leader of anti TNF - α antibody market The core treatment areas of our products include tumors, autoimmune diseases and others About Sansheng pharmaceutical, Sansheng pharmaceutical is a comprehensive biotechnology company, with the market leading biopharmaceutical business, covering cancer, autoimmune diseases, kidney disease, metabolic diseases, skin diseases and other treatment fields Sansheng pharmaceutical is committed to building an innovative product pipeline, and there are more than 30 candidate products under development Sansheng pharmaceutical has the ability to produce recombinant protein, monoclonal antibody and chemical synthetic molecular products It has R & D and production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Como, Italy This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.