天士力(600535.SH):多囊卵巢綜合症治療藥獲臨牀試驗通知
格隆匯1月13日丨天士力(600535.SH)公佈,近日,股市收到國家藥品監督管理局核准簽發的芪苓温腎消囊顆粒的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
芪苓温腎消囊顆粒擬用於治療脾腎陽虛、痰濕阻滯型多囊卵巢綜合徵(polycystic ovarian syndrome,簡稱PCOS)。本品具有温腎健脾,化痰利濕的功效,症見月經後期、閉經、形體肥胖、帶下量多、倦怠乏力或頭暈心悸、胸悶泛惡、大便溏薄或粘膩等。截至本公告日,公司對芪苓温腎消囊顆粒的累計研發投入為人民幣1210.76萬元。
多囊卵巢綜合症(PCOS)是以持續無排卵、高雄激素或胰島素抵抗為特徵的內分泌紊亂的症候羣。根據公開文獻報道,多囊卵巢綜合症(PCOS)主要影響着全球6%~10%的育齡女性,且佔不孕人羣的30%~40%,佔不排卵性不孕的75%左右。根據國內流行病學調查數據顯示,該病育齡女性患病率約為5.6%。
目前針對多囊卵巢綜合症(PCOS)的治療,相關的指南推薦藥物主要為排卵誘導劑、避孕藥、抗雄激素、促性腺激素等,但以上推薦藥物的適應症中均無多囊卵巢綜合症(PCOS)。在中成藥領域,國內尚無針對此適應症的已上市品種,芪苓温腎消囊顆粒上市後,可填補該適應症的市場空白。
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