Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct two clinical studies for lasofociene. The first trial is a Phase I study in healthy subjects, while the second is a global multi-center Phase III study. The Phase III study will evaluate lasofocine in combination with abemaciclib for the treatment of patients with estrogen receptor 1 (ESR1) mutated, estrogen receptor positive (ER+), and human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. The study will include premenopausal/postmenopausal women and men with disease progression following treatment with aromatase inhibitor (AI) combined with cyclin-dependent kinase (CDK 4/6) inhibitor.
Fosun’s subsidiary, Shanghai Henlius Biotech Inc., (HKG: 2696), entered into a licensing agreement with US firm Sermonix Pharmaceuticals Inc. in January this year, securing exclusive rights to develop, manufacture, and commercialize the drug in China. Lasofocine is an oral selective estrogen receptor modulator (SERM). Currently, only the selective estrogen receptor degrader (SERD) Orserdu (elacestrant) has been approved globally to treat breast cancer with ESR1 mutation, and no similar drug has been approved for this indication in China.- Flcube.com
