3SBio Group has always been committed to solving the problem of clinical drug use for patients, constantly conquering the challenges of the disease, using high-quality drugs to improve the quality of life of patients, and working hard for the benefit of human health. |
We have successfully achieved good results under the support of a comprehensive R & D platform. 3SBio relies on a professional R & D team composed of more than 300 scientists, and has a national engineering research center of antibody-based drugs and four comprehensive research and development centers of dual platform for biological and chemical drugs. Our comprehensive R & D expertise covers the discovery and development of biological drugs, including molecular cloning, gene expression, cell line construction and process development, as well as preclinical and clinical trials. The design and management of manufacturing process development and analysis process development is used for quality control and guarantee. Our R & D team spare no effort to accelerate the progress of clinical trials and develop breakthrough treatment protocols. We strive to work with global innovation partners to develop new products. Our R & D capabilities also make us one of the few Chinese companies that have signed licenses and licensing agreements with international partners. At present, we have a wealth of product series under study, and 25 kinds of alternative products, of which 16 serves as a new class of Chinese medicine. We have always focused on the development of leading biological drugs, including priming injections such as Trastuzumab, Rituximab, second-generation long-acting recombinant human erythropoietin (NuPIAO) and anti-tumor necrosis factor (anti-TNF), Pesiticase, Cetuximab, Etanercept and other McAb products.
We have five major production bases in the world, located in: Shenyang, Shanghai, Shenzhen, Hangzhou and Italy. We have accumulated a wealth of professional experience and knowledge in the manufacture of biopharmaceuticals. We are able to effectively and steadily achieve volume production of biological drugs, while ensuring the high quality of drugs. We have advanced production equipment: 11 production lines for antibody drugs, with a production capacity of more than 38,000 liters, and production lines for small molecular products, mammalian cell products and bacterial cell products. 3SBio’s production lines are awarded the latest certification of Good Manufacturing Practice (GMP) by National Medical Products Administration. 3SBio has implemented an unified quality management standards, and each of the raw materials are referred to the United States Pharmacopoeia, European Pharmacopoeia and Chinese Pharmacopoeia, and the relevant quality standards have been established to allow the raw materials to enter into the production process after rigorous testing. 3SBio’s drug registration standards have consistently adhered to the standards higher than the European Pharmacopoeia and Chinese Pharmacopoeia. 3SBio's antibody drugs are demarcated as national standards which are used for preparing and demarcating monoclonal antibody products by the National Medical Products Administration (NMPA), and 3SBio has been allowed to participate in the development of 3 items of drug national standards.
Our products cover various therapeutic fields, such as tumor, autoimmunity, nephrology, metabolism and dermatology and are in the market leading position and have strong growth momentum and huge growth potential:
• TPIAO: The world’s only commercial recombinant human thrombopoietin (rhTPO) which is an independent research and development product.
• YISAIPU: The first tumor necrosis factor (TNF-α) inhibitor in the field of rheumatism in China, as well as the first fully human antibody drug listed in China.
• Cipterbin: It is the first innovative anti-HER2 monoclonal antibody in China with the engineered Fc region, optimized production process and a stronger ADCC effect.
• Epiao and Sepo: The leaders of China’s recombinant human erythropoin market.
• Enter into an exclusive license agreement with AstraZeneca, obtaining the commercialization rights for Type 2 diabetes drugs Byetta and Bydureon in China.
• Enter into the exclusive license agreement with Lilly China, obtaining the commercialization rights for insulin product Humulin® in China.
We have a leading business platform, matched with eight major business units, and a professional team of medical information communication composed of about 1929 is committed to the promotion of professional compliance academics.We already have integrated compliance, market access, business operations, marketing, sales team efficiency and financial team, and the overall efficiency continues to improve. After years of professional training, we have established and maintained a solid relationship with leading hospitals and medical specialists; and our academic recognition and brand awareness have been promoted and strengthened within the medical experts.
We are continually devote ourself to our global business expansion. So far, Etanercept has obtained the listing approval in 15 countries, and is in a registration stage in more than 20 countries. We will be conduct a clinical trial for Tpiao in the United States, which is going to be approved in India and Mexico; and we have been conducting a multi-center biomimetic clinical trial for Epiao in Russia and Thailand. In the future, our goal is to achieve registration of new products in highly regulated markets through biosimilars.