恆瑞醫藥(600276.SH):獲得臨牀試驗通知書 涉及SHR7280片
格隆匯5月8日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司、成都盛迪醫藥有限公司近日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》。
藥品名稱為SHR7280片,審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年3月4日受理的SHR7280片符合藥品註冊的有關要求,同意按照增加150 mg規格和劑量的方案開展“擬用於雌激素依賴性疾病如子宮內膜異位症”的臨牀試驗。
SHR7280是一種口服小分子GnRH受體拮抗劑,可以阻斷內源性GnRH與GnRH受體的結合,抑制黃體生成素和卵泡刺激素等促性腺激素的合成和釋放,降低睾酮和雌二醇等性激素水平,治療包括子宮內膜異位症在內的激素依賴性疾病。
經查詢,艾伯維開發的同類產品惡拉戈利(商品名Orilissa)於2018年在美國獲批上市銷售;日本武田和Aska製藥以及Myovant Science共同開發的瑞盧戈利(商品名Relumina)於2019年在日本獲批上市;此外,ObsEva公司開發的GnRH受體拮抗劑Linzagolix,正在開展治療子宮內膜異位症和子宮肌瘤的III期臨牀研究。經查詢,Orilissa和Relumina的2019年全球銷售額約12200萬美元。
截至目前,該產品累計已投入研發費用約為2823萬元人民幣。
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