(Shanghai, China, 29 July 2019) Today, China’s leading biopharmaceutical company Sunshine Pharmaceuticals Co., Ltd. (01530.HK) announced, the application for new drug production of the antibody fusion protein medicine YISAIPU pre-filled solution (common name: Recombinant Human Tumor Necrosis Factor-α ReceptorⅡ: IgG-Fc Fusion Protein for Injection) independently developed by its Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd has been submitted to the National Medical Products Administration and accepted.
The YISAIPU pre-filled solution is the first self-developed pre-filled fusion protein for injection in China. It is indicated for the treatment of three indications: active ankylosing spondylitis, moderate to severe active rheumatoid arthritis, and moderate to severe plaque psoriasis in adults aged 18 and above. According to the study, the prevalence of these three diseases in China is about 0.3%, 0.4% and 0.1%. Currently, it is not ideal for patients’ compliance with the use of biological agents. Poor medication compliance is also an important cause of recurrent diseases.
YISAIPU pre-filled solution has made a great breakthrough in the process of domestic biological medicine preparation. Patients will no longer be confined to hospital treatment, but will be able to inject themselves at home, which is expected to greatly improve patients’ medication compliance and quality of life.
YISAIPU powder injection was launched in 2006, and more than 300,000 patients have benefited from the treatment, which is recognized by clinicians and widely trusted by patients. In 2017, it was listed as a Class B drug in National Reimbursement Drug List. YISAIPU pre-filled solution will bring more dosage options and more patients are expected to benefit.
Dr. Jing Lou, chairman and CEO of 3SBio said, “We are very pleased to see the successful submission of the application for new drug production of YISAIPU pre-filled solution. 3SBio will continue to focus on the field of biologics by exploring and developing more therapeutic biologics in different dosage forms to meet different medical needs and provide more choices for patients.”
Data source
1. Chinese Journal of Bone Surgery, 2012
2. Chinese guidelines for diagnosis and treatment of rheumatoid arthritis, 2018
3. Chinese guidelines for diagnosis and treatment of psoriasis, 2018
About YISAIPU
YISAIPU (Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ: IgG-Fc Fusion Protein for Injection, rhTNFR:Fc) targets major inflammatory mediator - TNF-α in the pathologic processes of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. It can bind to TNF-α, and inhibit the biological activity of TNF-α, so as to achieve the therapeutic effect. With recombinant DNA technology, YISAIPU constructed an eukaryotic expression vector containing fusion gene of human tumor necrosis factor-α receptor Ⅱ (P75) extracellular domain coding region and human IgG1- Fc fragment coding region, gene transfer Chinese Hamster Ovary (CHO-K1 cell), thus achieving high-efficiency expression of rhTNFR:Fc.
About Sunshine Guojian
Founded in 2002, Sunshine Guojian is an innovative biopharmaceutical enterprises specializing in antibody drugs and is also a high-tech enterprise with independent capabilities in research and development, manufacturing and commercialization. The company prioritizes R&D in innovative therapeutic antibody drugs, and provides high-quality, safe and effective clinical solutions for the treatment of autoimmune diseases, tumors and other major diseases. At present, the company has 15 antibody drugs (including 7 drugs in clinical phase and post-market clinical follow-up, 8 drugs in pre-clinical phase) in different development phases, covering tumor, autoimmunity and ophthalmology and other disease areas, most of which are Class 1 biological products or monoclonal antibodies for therapeutic use.
About 3SBio
3SBio is a comprehensive biotechnology company with a market-leading biopharmaceutical business, which covers tumors, autoimmune diseases, kidney diseases, metabolic diseases, skin diseases and other treatment fields. 3SBio Is committed to building an innovative product pipeline, and more than 30 product candidates are currently in development. The company has established R&D and production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Como, Italy with the production strength in recombinant protein, monoclonal antibodies and chemosynthetic molecule. For more information, please visit www.3sbio.com.
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