Dragon Pharmaceutical Inc. (TSX: DDD; OTC BB: DRUG) today announced that it has received market approval from the Chinese State Drug Administration (SDA) for the use of rHu Erythropoietin (EPO) in surgical patients in China and a new dosage presentation of 6000 IU which will be used for this new indication. Prior to receiving this additional approval in China, Dragon’s EPO has already been approved and marketed for use in the treatment of anemia related to chronic renal failure in China and for both indications in India, Egypt, Peru and Brazil.
Many patients undergoing surgery are concerned about blood loss. To combat blood loss during surgery, patients can receive a blood transfusion from banked blood supplies, donate their own blood before surgery for transfusion or build up their supply of red blood cells prior to surgery. With greater convenience and no risk of blood-borne contaminants or incompatibility, Dragon’s EPO helps increase the body’s natural supply of erythropoietin, a protein made in the kidneys that is critical to red blood cell production and stimulates bone marrow to produce progenitor cells, which mature into red blood cells.
Like many other advanced regulatory bodies, Chinese SDA has strict requirements for manufacturers of EPO to conduct extensive clinical studies prior to issuance of approval for its use in treating additional indications. This is to ensure the safety and efficacy of the product in the high therapeutic dosages associated with the indication.
The dosage required for surgical patients is usually many times higher than the use in treating anemia associated with chronic renal failure. The approval will expand the market opportunities for Dragon’s EPO in the existing approved countries. “We are confident that Dragon’s competitive cost advantages, its clinically tested EPO at proper dosages for surgery indication and the distribution network in 136 countries built by our licensees will enable Dragon to capture the additional market opportunities as a result of the new approval.” said, Dr. Wick, President of Dragon. “In addition to the approved indications for use in the treatment of anemia related to chronic renal failure and surgical patients, we are also actively pursuing clinical trials for cancer radio and chemotherapy patients in China. Dragon intends to submit a market approval application to the Chinese SDA in 2003 together with the new 10000 IU dosage that will be used in association with this new indication.”
About Dragon Pharmaceutical Inc. Dragon Pharmaceutical Inc. is an international biopharmaceutical corporation engaged in the discovery, development and commercialization of genetically engineered human proteins for therapeutic use. Based on its proprietary protein expression technology, Dragon believes that it has become one of the world’s most competitive producers of EPO, a breakthrough drug that has revolutionized the treatment of anemia. Dragon is also applying its platform technology to the development of other generic and novel protein drugs.