百奧泰(688177.SH):託珠單抗注射液(施瑞立®)的藥品上市許可申請已處於“審批完畢-待制證”階段
格隆匯1月16日丨百奧泰(688177.SH)公佈,2023年1月16日,百奧泰生物製藥股份有限公司從國家藥品監督管理局網站查詢獲悉,公司提交的BAT1806(託珠單抗)注射液(以下簡稱施瑞立®)的藥品上市許可申請已處於“審批完畢-待制證”階段,該狀態表示國家藥監局已審批完畢,其相應行政部門正在製作藥品註冊批件。
施瑞立®(BAT1806)是百奧泰根據中國NMPA、美國FDA、歐盟EMA生物類似藥相關指導原則開發的託珠單抗注射液。施瑞立®是一款靶向白介素-6受體(IL-6R)的重組人源化單克隆抗體,可與可溶性和膜結合型IL-6受體(sIL6R和mIL-6R)特異性結合,並抑制由sIL-6R或mIL-6R介導的信號傳導。
截至公吿披露日,原研藥託珠單抗(雅美羅®)已在國內獲批用於治療類風濕關節炎(RA)、全身型幼年特發性關節炎(sJIA)和細胞因子釋放綜合徵(CRS);在海外獲批用於治療類風濕關節炎(RA)、鉅細胞動脈炎(GCA)、系統性硬化症相關間質性肺疾病(SSc-ILD)、多關節型幼年特發性關節炎(pJIA)、全身型幼年特發性關節炎(sJIA)、細胞因子釋放綜合徵(CRS)和新型冠狀病毒肺炎(COVID-19)。
目前,託珠單抗注射液被納入《新型冠狀病毒感染診療方案(試行第十版)》和《新型冠狀病毒感染重症病例診療方案(試行第四版)》,對於重症病例且實驗室檢測IL-6水平明顯升高者可試用。方案中對於兒童特殊情況的處理中提到,兒童發生腦炎、腦病等神經系統併發症可酌情選用;兒童發生多系統炎症綜合徵(MIS-C)若接受治療後無好轉或加重,可使用託珠單抗。
百奧泰與Biogen International GmbH(簡稱“Biogen”)於2021年4月簽署授權許可與商業化協議,將公司的BAT1806(託珠單抗)注射液在除中國地區(包括中國大陸、香港特別行政區、澳門特別行政區、台灣)以外的全球市場的獨佔的產品權益有償許可給Biogen,其產品編號為BIIB800。
截至公吿披露日,公司施瑞立®已獲國家藥品監督管理局批准上市,已向美國FDA以及歐洲EMA遞交上市許可申請並已獲得受理。
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