CHINA CERTIFIES PHARMAGENESIS' BONE MARROW STIMULANT PG2.China's State Drug Administration (SDA SDA abbr. specific dynamic action Serotonin dopamine antagonist (SDA) The newer second-generation antipsychotic drugs, also called atypical antipsychotics. ) has awarded Pharmagenesis Inc., Palo Alto, Calif., a new drug certificate for its plant-derived hematopoiesis Hematopoiesis The process by which the cellular elements of the blood are formed. The three main types of cells are the red cells (erythrocytes), which serve to carry oxygen, the white cells (leukocytes), which function in the prevention of and recovery from enhancer, PG2, bringing the company a step closer to producing and marketing the medicine for patient use. PG2 is an adjunct to cancer therapy that restores activity of bone marrow after a patient's bone marrow has been destroyed by chemotherapy. Pharmagenesis' drug passed strict SDA clinical trials in China earlier this year. "PG2 has proven effective in enhancing a patient's quality of life during the trauma of cancer therapy," Nicolas Druz, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Pharmagenesis, said. "In addition to restoring blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. , PG2 helps patients feel better, eat better, sleep better and have more energy. As such, PG2 will have a strong appeal on Chinese physicians and patients. Pharmagenesis also plans to develop derivatives of PG2 for the Western world." The China SDA is the regulatory equivalent of the U.S. Food and Drug Administration and employs stringent regulations similar to those used in U.S. drug trials. The SDA issues new drug certificates only after a thorough review of scientific findings gathered during clinical trials. The certificate confirms the drug is safe and effective. Pharmagenesis will now pursue a good manufacturing practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (GMP GMP (guanosine monophosphate): see guanine. ) certificate to produce the drug in China. The SDA issues a GMP after inspecting the facility used to produce a medicine. Once Pharmagenesis has obtained the GMP certificate, it can manufacture and market PG2 for patient use. Pharmagenesis plans to start PG2 production and sales in first half of 2002. About Pharmagenesis Inc. Pharmagenesis Inc. develops anticancer therapies and treatments for cancer therapy-related bone-marrow suppression and for the management of transplant rejection. The privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. focuses on developing ethical pharmaceuticals from purified extracts of plants that have been employed in traditional Chinese medicine Traditional Chinese Medicine Definition Traditional Chinese medicine (TCM) is an ancient and still very vital holistic system of health and healing, based on the notion of harmony and balance, and employing the ideas of moderation and prevention. for more than 4,000 years. Efficacy is validated by clinical trials conforming to standards of appropriate government regulatory agencies. Pharmaceuticals developed and/or licensed by the company are being commercialized initially in the high-growth markets of China and Taiwan. Pharmagenesis' corporate headquarters and R & D facility, which employs cutting-edge Western medical research techniques, are located in Palo Alto, Calif. Pharmagenesis also has operations in Beijing and Taipei. For more information, call (310)785-0515. |
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