“Combining Pharming’s validated technology platform with SIPI’s capabilities in manufacturing, development, domestic regulatory and Sinopharm’s commercialisation network, we have created an opportunity to provide for China’s rapidly increasing need to domestically developed world- class quality biological medicines and to bringing to Chinese patients affordable biological medicines.” -Dr. Weigen Lu, President of SIPI
Shanghai Institute of Pharmaceutical Industry, a research institute, engages in the research of organic synthesized pharmaceuticals, microbiological and biochemical pharmaceuticals, biotechnological drugs, traditional Chinese medicines and novel preparations, pharmaceutical preparations, and new drug delivery systems. The company was founded in 1957 and is based in Shanghai, China. As of December 11, 2012, Shanghai Institute of Pharmaceutical Industry operates as a subsidiary of China State Institute of Pharmaceutical Industry.
The China State Institute of Pharmaceutical Industry and the China National Pharmaceutical Group Corporation, (Sinopharm) comprises the largest medical and healthcare group in China which is directly managed by State-owned Assets Supervision and Administration Commission of the State Council (SASAC). Their core business is the distribution, logistics, retail, scientific research and manufacture of healthcare related products.
Sinopharm is aiming to be an international pharmaceutical and healthcare group which will cover the whole industrial chain and give strong impetus to the industry.
Ruconest® in China
Ruconest® in China
Pharming’s technology and manufacturing know- how, will be transferred to SIPI, such that joint global development for new products can take place at SIPI’s facilities in Shanghai, benefiting from both the cost advantages of the Pharming’s platform and the competitive development and manufacturing costs structures at SIPI.
SIPI will retain an exclusive licence to commercialize, develop and manufacture Ruconest in China; it will also take part in the continuing development of rhFVIII and other therapeutic biological of mutual interest.
The strategic collaboration with Shanghai Institute of Pharmaceutical Industry (SIPI), effectuated in 2013, represented an important step forward towards building a pipeline of new products using our technology platform. Under the collaboration our entire technology platform, quality assurance and quality control (QA/QC) processes, and production system are being transferred to the SIPI Shanghai facilities. Pharming and SIPI intend to develop new compounds from this facility. SIPI will have commercialisation rights for China and its territories. Pharming will have commercialisation rights ex-China. SIPI will supply Pharming at a “cost–plus” basis.
The first new compound to be jointly developed is recombinant human Factor VIII for the treatment of Haemophilia A. Haemophilia A is an X chromosome linked hereditary disorder caused by defects in the Factor VIII gene that leads to lower levels of the functional Factor VIII protein. Lack of functional Factor VIII diminishes the body’s clotting ability, which in turn can lead to damaging or fatal bleeding episodes.
SIPI also obtained development and commercialisation rights for China and its territories for Ruconest. The manufacturing process for Ruconest is also being duplicated at SIPI, under all of the Pharming QA/QC and manufacturing standards, such that SIPI could manufacture rhC1 inhibitor for China and its territories, but could also supply Pharming in the future.
For more information about SIPI and its partnership with Pharming please click here.