Our lead product, epoetin alpha injection (EPO), is an engineered form of a human protein, erythropoietin. This protein is naturally produced by the kidneys and stimulates the growth of red blood cells. When red blood cell counts are low, patients develop anemia which may require multiple blood transfusions and, in some cases, can lead to heart disease and even death.
The introduction of EPO has revolutionized the management of anemia in patients with kidney disease or receiving radiation or chemotherapy for cancer, minimizing weakness, fatigue, and the need for blood transfusions.
Dragon’s EPO has major cost advantages over other EPOs. Our proprietary manufacturing process produces EPO at yields several times higher than those generated by the world’s leading EPO manufacturers, allowing us to sell high grade efficacious product at competitively low prices. In a large-scale phase III multicenter controlled clinical trial, our EPO was effective and well-tolerated in 1079 patients with chronic renal disease.
Our state-of-the-art commercial manufacturing facilities have been certified as compliant with the World Health Organization’s Good Manufacturing Practices (GMP). Dragon’s EPO has been approved by the Chinese State Drug Administration (SDA) for use in patients with end stage kidney (renal) disease, is endorsed by the Chinese Medical Association, and is currently used by 75% of Chinese hospitals with renal dialysis facilities. It is currently marketed in China under the NingHongXinR brand name.
We intend to distribute EPO worldwide and, because of our lower unit costs and highly competitive prices, will be able to make EPO more affordable and accessible to a wider range of countries and patients than at present.
Dragon’s EPO is also in phase II clinical trials for 2 other patient groups: those undergoing elective surgery who need to increase their red blood cell counts in advance of their operations, and those with anemia resulting from cancer radiation therapy or chemotherapy. Chinese New Drug License submissions for these applications are planned for the end of 2001 and for early 2002.
