恆瑞醫藥(600276.SH):酒石酸布托啡諾注射液通過仿製藥一致性評價
格隆匯5月23日丨恆瑞醫藥(600276.SH)公佈,近日,江蘇恆瑞醫藥股份有限公司收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,公司酒石酸布托啡諾注射液通過仿製藥質量和療效一致性評價。
布托啡諾是μ-阿片受體的部分激動劑,也是κ-阿片受體的完全激動劑,主要治療作用是鎮痛。布托啡諾呼吸抑制、藥物依賴性和成癮性發生率較低,廣泛應用於臨牀麻醉誘導和術後鎮痛。
酒石酸布托啡諾注射液最早由Apothecon公司開發,並於1978年8月獲FDA批准上市,商品名為Stadol。由於目前Apothecon公司的原研產品已撤市停售,FDA指定Hospira公司生產的酒石酸布托啡諾注射液為標準制劑(RS)。公司開發的酒石酸布托啡諾注射液有1ml:1mg、2ml:4mg兩種規格,分別於2007年、2014年獲批上市,商品名為諾揚。除公司外,國內目前暫無其他家公司的酒石酸布托啡諾注射液上市銷售。
經查詢,2021年布托啡諾相關劑型全球銷售額約為2.08億美元。截至目前,酒石酸布托啡諾注射液仿製藥一致性評價工作累計已投入研發費用約387萬元。
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