The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, HLX78 (lasofoxifene) was approved by the National Medical Products Administration to commence in mainland China (excluding Hong Kong, Macau and Taiwan regions, the same as below): (1) a phase 1 clinical trial of HLX78 in Chinese healthy subjects; and (2) an international multi-center phase 3 clinical trial and the indication is HLX78 in combination with Abemaciclib for the treatment of pre and postmenopausal women and men who have previously received aromatase inhibitor (AI) combined with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2) breast cancer with an estrogen receptor 1 (ESR1) mutation. The Company proposes to commence relevant clinical trials in mainland China when the conditions are fulfilled.
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- Shanghai Henlius Biotech, Inc. Announces Approval of Application for Clinical Trials of HLX78 (lasofoxifene) by the National Medical Products Administration