SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized, open, and multi-center, aims to evaluate the efficacy of elacestrant in treating Chinese postmenopausal women or men with advanced breast cancer that is estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), and carries estrogen receptor 1 (ESR1) mutations. The study will compare elacestrant’s effectiveness with the standard of care in patients who have previously received first or second-line endocrine therapy.
Elacestrant, which was entrusted to Radius Health for global development in 2006, was later licensed to the Italy-based Menarini Group in July 2020, granting them exclusive global commercialization rights. In December of the previous year, SciClone entered into a licensing and cooperation agreement with Menarini, securing exclusive rights to develop and commercialize the drug in China. This followed the initiation of a real-world study in an academic hospital in Boao, Hainan province, two months prior.- Flcube.com
