麗珠集團(000513.SZ)：取得重組人促卵泡激素注射液臨牀批件
格隆匯9月10日丨麗珠集團(000513.SZ)公佈，近日，公司控股附屬公司珠海市麗珠單抗生物技術有限公司(簡稱“麗珠單抗”)收到國家藥監局核准簽發的關於重組人促卵泡激素注射液的《藥物臨牀試驗批准通知書》。
重組人促卵泡激素注射液歷經2年研發，是麗珠單抗自主開發的促性腺激素類輔助生殖藥物，首次提交臨牀試驗申請獲得受理的時間為2021年7月2日(受理號：CXSL2101170)。
重組人促卵泡激素注射液是默克公司果納芬®(Gonal-f®)的生物類似藥，適應症為：(1)無排卵(包括多囊卵巢綜合徵[PCOS])且對枸櫞酸克羅米酚治療無反應的婦女。(2)在輔助生育技術(ART)如體外受精(IVF)、配子輸卵管內轉移(GIFT)和合子輸卵管內移植(ZIFT)中進行超排卵的婦女，使用重組人促卵泡激素注射液可刺激多卵泡發育。(3)嚴重缺乏促黃體激素(LH)和促卵泡激素(FSH)的患者，即內源性的血清LH水平＜1.2IU/L的患者。推薦LH與FSH聯合使用以刺激卵泡的發育。該產品為每支預裝0.75mL注射液的預充注射筆，無附帶溶劑和給藥裝置，給藥途徑為皮下注射。
截至該公吿日，重組人促卵泡激素注射液累計直接投入的研發費用約為人民幣2968.81萬元。
根據藥監局及CDE審評中心網站數據庫顯示，截止該公吿日，重組人促卵泡激素類注射筆產品目前國內共有2個進口品種獲批上市，獲批臨牀試驗2家(包括麗珠單抗的重組人促卵泡激素注射液)。
根據IQVIA抽樣統計估測數據，2020年促卵泡激素(FSH)藥物國內終端銷售金額約為人民幣18.89億元，其中重組人促卵泡激素(rFSH)藥物國內終端銷售金額約為人民幣13.34億元。2021年上半年促卵泡激素(FSH)藥物國內終端銷售金額約為人民幣11.15億元，其中重組人促卵泡激素(rFSH)藥物國內終端銷售金額約為人民幣7.92億元。
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