Gelonghui, May 14 | Fosun Pharmaceutical (600196.SH) announced that the company's holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. and its holding subsidiary (hereinafter collectively referred to as “Fuhong Hanlin”) recently received approval from the State Drug Administration for HLX78 (lasoxifene tablets, hereinafter referred to as “the new drug”) in China (excluding Hong Kong, Macao and Taiwan regions, the same below):
1. Phase I clinical trial on healthy subjects; 2. International multicenter phase III clinical trial. Indications: The new drug is used to treat locally advanced or metastatic breast cancer in premenopausal and postmenopausal women and men who have received aromatase inhibitors (AI) combined with cyclin-dependent kinase (CDK4/6) inhibitors and have progressed during treatment with estrogen receptor 1 (ESR1) mutations, positive estrogen receptor (ER+), human epidermal growth factor receptor 2 negative (HER2-). Fu Hong Hanlin plans to conduct the above clinical trials on this new drug in China after conditions are met.
The new drug is an oral selective estrogen receptor modulator (SERM) introduced by Fuhong Hanlin from Sermonix Pharmaceuticals, Inc. and is intended for the treatment of ER+/HER2- breast cancer; Fuhong Hanlin has its exclusive license in China (including Hong Kong, Macao and Taiwan). As of the date of this announcement, the new drug combined with abecilil has progressed during treatment with an aromatase inhibitor (AI) combined with a cyclin-dependent kinase (CDK 4/6) inhibitor, has progressed, has an estrogen receptor 1 (ESR1) mutation, positive estrogen receptor (ER+), human epidermal growth factor receptor 2 negative (HER2-), pre- and post-menopausal breast cancer in the United States, Europe, Canada and other places in the United States, Europe, Canada, etc., in the United States, Europe, Canada and other places where the disease progresses.