君實生物(688180.SH):君邁康®用於治療類風濕關節炎、強直性脊柱炎及銀屑病的藥品上市許可申請已處於“審批完畢-待制證”階段
格隆匯3月2日丨君實生物(688180.SH)公佈,2022年3月2日,公司從國家藥品監督管理局(“國家藥監局”)網站查詢獲悉,公司提交的阿達木單抗注射液(項目代號:UBP1211,商品名:君邁康®)用於治療類風濕關節炎、強直性脊柱炎及銀屑病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。
腫瘤壞死因子(TNF-α)由巨噬細胞、肥大細胞和被激活的TH細胞分泌,為炎症反應的強效誘導劑和先天免疫的關鍵調節器,在多種炎症的發生和發展中處於核心地位。TNF-α和TNF-α受體結合可誘導炎症反應,現已證明,類風濕關節炎、銀屑病、克羅恩病、強直性脊柱炎等多種自身免疫性疾病與TNF-α密切相關。抗TNF-α單克隆抗體可結合TNF-α受體,降低TNF-α激活的免疫應答,從而阻止炎症的發生。抗TNF-α單克隆抗體是一種治療免疫介導的炎症性疾病的新一代療法,具備療效高、安全性高且給藥方便的特點。君邁康®曾獲得“十二五”國家“重大新藥創制”科技重大專項支持。
2017年8月,公司與邁威(上海)生物科技股份有限公司(“邁威生物”)全資子公司江蘇泰康生物醫藥有限公司(“泰康生物”)訂立合作研究、開發及商業化協議,共同開發君邁康®及享用所有相關知識產權。(具體內容詳見公司於2020年7月8日披露於上海證券交易所網站的《首次公開發行股票並在科創板上市招股説明書》。)2020年11月,公司與邁威生物、泰康生物訂立補充協議,約定君邁康®上市後由公司與邁威生物共同投資設立的合資公司作為藥品上市許可持有人(MAH),合資公司的利潤由公司與邁威生物按50:50進行分配,邁威生物或其控股子公司將負責君邁康®的生產和銷售。
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