Dragon Pharmaceuticals Inc. is pleased to announce that it has been granted regulatory approval from the Chinese State Drug Administration (SDA) to enter Phase II clinical trials for two additional applications of the company’s lead product Erythropoietin (EPO).
The efficacy of Dragon’s EPO, which stimulates the production of red blood cells, will be evaluated in surgical patients who wish to avoid, or are not candidates for, transfusion of human donor-sourced blood and also in cancer patients with anemia resulting from either radiation or chemotherapy.
The clinical trial in surgical patients was initiated in December 2000, while the clinical trial in cancer patients is scheduled to begin in February 2001. Dragon expects to complete both Phase II trials by the end of 2001 and then immediately apply for SDA approval to market EPO in China for these additional indications.
“Currently, treatment for patients with anemia due to chronic renal failure is the only SDA-approved application for EPO in China. Dragon Pharmaceuticals now intends to pioneer the approval of additional applications for EPO,” said Dragon President and CEO, Dr. Longbin Liu. “Once we receive SDA approval, we will be well positioned to extend EPO registration into our established distribution channels.”
Dragon has built a distribution base of 530 hospitals across China, representing 75% of hospitals with renal dialysis facilities. International product orders have, to date, been placed by distributors in Brazil, Egypt, and Malaysia. The Company is currently in the process of establishing product registrations and distributor agreements across Southeast Asia, the Middle East, Latin America and Eastern Europe.
According to IMS estimates, the 1999 North American sales of proprietary manufacturer-produced EPO for surgical and cancer related uses was $1.2 billion. Sales of EPO to countries outside of North America and the European Union for these indications have been severely limited to date primarily because of the high cost of proprietary product.
The PRC Ministry of Health estimates that approximately 20 million surgical procedures are performed annually in China in which the patient is likely to require a blood transfusion. In addition, up to 2 million cancer patients in China per year receive chemotherapy or radiation therapy that puts them at risk of developing anemia.
About Dragon Pharmaceuticals Inc. Dragon Pharmaceuticals is an international biopharmaceutical corporation engaged in the development and commercialization of generic as well as novel and patentable therapeutics. Based on its proprietary protein expression technology, Dragon has become one of the world’s lowest cost producers of Erythropoietin (EPO), and is in the process of applying its platform technology to a pipeline of additional products.