Shandong Geneleuk Biopharmaceutical Co. , Ltd.

Shandong GeneLeuk Biopharmaceutical Co., Ltd., of China is a Sino-US joint venture involving in the area of R&D, manufacture and marketing of recombinant DNA pharmaceuticals with registration capital of US$26millions and area of 28000m2. The major investors are Jiufa Corporation Ltd., a listed company in Shanghai Stock Exchange, and GeneTech Biomedical Inc., a US high-tech company, who is responsible for the necessary technology and management.

All the buildings and equipment were designed and constructed according to the GMP standard of FDA. GeneLeuk passed the GMP certificate of State Drug Administration of China in 1999. In the R&D, manufacturing, marketing and sales of new drugs, GeneLeuk conforms to the international standard of GLP, GCP and GMP.

R&D center of GeneLeuk is located in Long Island, New York, USA. Pilot production and manufacture bases are in JiNan City, China. Sales & marketing center is in Beijing City of China.

Its product on the market is Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF or Filgrastim) with the trademark of GeneLeukim®. RhG-CSF is a haematopoietic growth factor, which principally regulates the formation and development of neutrophiles within the bone marrow and stimulates their release into the peripheral circulation. GeneLeukim® is indicated to decrease the incidence of infection as manifested by neutropenia in patients with malignancies receiving myelosuppression anti-cancer drugs associated with a significant incidence of severe neutropenia. For high-dose chemotherapy, GeneLeukim® makes chemotherapy safer and more effective as well as reduces antibiotics use duration and hospitalization costs.

Products under R&D are the followings: rhPA (Recombinant Human Plasminogen Activator), rhTNF (Recombinant Human Tumor Necrosis Factor), PEG-rhG-CSF(PEG-Filgrastim), rhGM-CSF, rhIL-2, rhIL-6, etc.  Among of them, the PEG-rhG-CSF has entered into Clinical Trials, which would be put into the market half year later. The product rhSOD bulk (Superoxide Dismutase) is available now.