Redpharm was founded in 2016 and headquartered in Wangjing SOHO, with a registered capital of RMB100 million.
With robust funding and strategic planning for global drug registration, Redpharm has attracted a galaxy of senior experts in healthcare, medical research, pharmacology, and other medical-related fields from around the world. At the beginning of its operation, Redpharm signed a technology transfer agreement for ALTAPURE™, a large-scale biological product purification and preparation platform, thus having the rights and interests in development and commercialization of glutaraldehyde-polymerized bovine hemoglobin-based oxygen therapeutics (also known as Blood Substitute or HBOC) which derive from ALTAPURE™. The business scope of Redpharm also covers R&D and manufacturing of POCT (point-of-care testing), ACTH and BSA, as well as CRO/CMO technical services.
Redpharm products have huge clinical needs in the context of rapid diagnosis and pre-hospital first aid. At present, the company is building a cGMP factory and an R&D platform that meet both cFDA and FDA standards in Yizhuang National Economic-Technological Development Area, Beijing. Redpharm is planning to export intermediate products to European Union and the United States in 2019. In five years, the company will build a 70000-square meter manufacturing base for biomedicine and diagnostic instruments in China. With the support of existing quality management system and state-of-the-art R&D and manufacturing equipment, Redpharm has set its eyes on both human and animal medicine and diagnosis markets in Greater China and around the world. Redpharm will always adhere to the spirit of "Inspired life science", never forget why we started, and strive for a better future for global health and animal/human well-being.
Obtained Certificate of Suitability to Monograph of European Pharmacopoeia, CEP or COS in May, 2018
ALTAPURE™ Technology PlatformALTAPURE™ technology platform is devoted to large-scale protein purification and separation using HPLC (High Performance Liquid Chromatography) column. The platform has broken through a long-standing bottleneck hindering the biological product manufacturing, i.e., the versatility of protein purification and preparation technology. On this technology platform, different protein products can be purified in flexible manner to obtain high yield, and at the same time, with superior technology, repeatable production of accurate and appropriately folded proteins can be ensured. International patent has been applied for this innovative platform technology, and the applications of the platform will be further extended to development of peptides, antibodies and other biological products.
As the only company engaged in R&D, production, and marketing of HBOC (hemoglobin-based oxygen carrier) products in China, Redpharm aims to promote the development of the industry and enhance academic exchanges. All relevant documents related to HBOC-2001 and HBOC-2012 will be disclosed in this section, for reference of our colleagues in the field.Notes: 1. BIOPURE’s veterinary product for the treatment of anemia in dogs is the only oxygen therapeutic approved by the FDA and EMA in 1998 and 1999 respectively. 2. Biopure’s first-in-class product for human use, was approved in South Africa to treat acutely anemic surgery patients, and to eliminate, reduce or delay the need for allogeneic red blood cells in these patients. In October 2002, FDA accepted for review Biopure’s application to market oxygen therapeutics for human use in the United States for a similar indication in orthopedic surgery patients. In 2010, Biopure oxygen therapeutic was approved by Regulatory Authorities for human use in Russia.
2月27日至28日，由美国药典委员会(USP)主办的 “一次性使用系统”（Single Use System，SUS）国际研讨会在北京召开。