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复宏汉霖(02696.HK)：HLX78(拉索昔芬片)的临床试验申请获国家药监局批准

Fu Hong Han Lin (02696.HK): Clinical trial application for HLX78 (lasoxifen tablets) approved by the State Drug Administration

Gelonghui Finance ·  May 14 05:03

Gelonghui, May 14 | Fu Hong Han Lin (02696.HK) issued an announcement. Recently, HLX78 (lasoxifene tablets, lasofoxifene) (“HLX78”) was approved by the State Drug Administration to be carried out in China (excluding Hong Kong, Macao and Taiwan regions, the same below): (1) a phase 1 clinical trial in healthy Chinese subjects; and (2) an international multi-center phase 3 clinical trial. The indications are HLX78 combined with abecilil treated with aromatase inhibitor (AI) combined with cyclic kinase (CD) K4/ 6) Locally advanced or metastatic breast cancer in pre- and post-menopausal women and men with progressing disease during inhibitor treatment, with estrogen receptor 1 (ESR1) mutations, positive estrogen receptor (ER+), and negative human epidermal growth factor receptor 2 (HER2-). The company plans to conduct relevant clinical trials in China when conditions are met.

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