The radiopharmaceutical technology brought in by Shanghai Yi Tai Pharmaceutical Technology Co., Ltd. is a considered as a Class I Innovative drug in China. It can be used for pain-relief in advanced bone metastases. The project, which is the Company's focus, is currently under clinical phase II trial. This has the support of the Oak Ridge National Laboratory (USA), Institute of Radionuclides of Belgium, and University of Bonn (Germany).The initial project with 188Re-HEDP could form the basis for development of further “biological missile” drugs, using 188Re as warhead.
188Re is a short half-life nuclide with low toxicity. It can be handled safely and environmentally friendly. Its beta radiation has suitable therapeutic applications, and it's small amount of gamma irradiation can be used for imaging. It is often considered as “the ideal medical radioisotope”.
Despite the fact that it is universally acknowledged that the present nuclide has an optimal application value, it was very difficult to produce. Because of its short half-life, its application previously stayed at the theoretical research stage, until Dr Knapp from Oak Ridge Institute has invented the 188W-188Re generator, which brought broad applications prospect.
Yi Tai has the domestic patent of the 188W-188Re generator, and it is collaborating with Belgium Institute of Radionuclides, to introduce the latter's advanced generator and concentrator production technology into The China market.
It is plan to establish a radiopharmaceutical research and development platform, including a GMP facility for drug preparation, a Class B GMP facility for radioactive drug preparation and labeling. The facilities will be fully integrated and built according to both national State Food and Drug Production quality and international drugs production cGMP standards. We will also set up a facility supporting generator and concentrator productions in compliance with GMP standards for medical equipment. The total area of these facilities is about 5000 m2.