Lantheus announces China NMPA approval of DEFINITY

Lantheus Holdings announced that the Center for Drug Evaluation of China’s National Medical Products Administration has approved the Import Drug License for Perflutren Lipid Microsphere Injectable Suspension the Company’s diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. The Company’s partner, China Resources Double-Crane Pharmaceutical, will be responsible for commercializing DEFINITY in China under a local brand name. Under the distribution agreement, Lantheus will supply DEFINITY to CR Double-Crane for a launch in China. With this approval, DEFINITY is indicated in China for use in patients with suboptimal conventional echocardiography and to better identify the left ventricular endocardial border. Lantheus entered into a development and distribution arrangement with CR Double-Crane for the commercialization of DEFINITY in China, Hong Kong and Macau. As part of the agreement with Lantheus, CR Double-Crane conducted confirmatory clinical trials with DEFINITY on Lantheus’ behalf in pursuit of cardiac, liver and kidney imaging indications, as well as a pharmacokinetic study.