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復星醫藥(600196.SH):HLX78獲藥品臨牀試驗批准

格隆匯5月14日丨復星醫藥(600196.SH)公佈,公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司(以下合稱“復宏漢霖”)於近日收到國家藥品監督管理局關於同意HLX78(即拉索昔芬片lasofoxifene,以下簡稱“該新藥”)於中國境內(不包括港澳台地區,下同)開展如下臨牀試驗的批准:

1、健康受試者的I期臨牀試驗;2、國際多中心III期臨牀試驗,適應症:該新藥聯合阿貝西利治療接受過芳香化酶抑制劑(AI)聯合細胞週期蛋白依賴性激酶(CDK4/6)抑制劑治療期間發生疾病進展的、攜帶雌激素受體1(ESR1)突變的、雌激素受體陽性(ER+)、人表皮生長因子受體2陰性(HER2-)的絕經前/後女性與男性局部晚期或轉移性乳腺癌。復宏漢霖擬於條件具備後於中國境內就該新藥開展上述臨牀試驗。

該新藥為復宏漢霖自 Sermonix Pharmaceuticals, Inc.許可引進的口服選擇性雌激素受體調節劑(selective estrogen receptor modulator,SERM),擬用於ER+/HER2-乳腺癌的治療;復宏漢霖擁有其在中國(含港澳台地區)的獨佔許可。截至本公吿日,該新藥聯合阿貝西利治療接受過芳香化酶抑制劑(AI)聯合細胞週期蛋白依賴性激酶(CDK 4/6)抑制劑治療期間發生疾病進展的、攜帶雌激素受體 1(ESR1)突變的、雌激素受體陽性(ER+)、人表皮生長因子受體 2 陰性(HER2-)的絕經前/後女性與男性局部晚期或轉移性乳腺癌於美國、歐洲、加拿大等地處於國際多中心 III 期臨牀試驗階段。

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