海正藥業(600267.SH):海正生物注射用英夫利西單抗獲批上市
格隆匯9月28日丨海正藥業(600267.SH)公佈,2021年9月28日,博鋭生物全資子公司海正生物製藥有限公司(簡稱“海正生物”)收到國家藥監局核准簽發的“注射用英夫利西單抗”的《藥品註冊證書》。
2020年5月6日,國家藥監局受理了公司遞交的注射用英夫利西單抗藥品註冊申請。本品為Janssen Biologics B.V.公司類克®(通用名:注射用英夫利西單抗)的生物類似藥,是一種特異性阻斷腫瘤壞死因子(TNF-α)的人鼠嵌合型單克隆抗體,可與TNF-α的可溶形式(sTNF-α)和跨膜形式(tmTNF-α)以高親和力結合,抑制TNF-α與受體結合,從而使TNF失去生物活性。申請適應症為類風濕關節炎、成人及6歲以上兒童克羅恩病、瘻管性克羅恩病、強直性脊柱炎、銀屑病和成人潰瘍性結腸炎。本品嚴格按照生物類似藥指導原則開發,藥學、非臨牀以及臨牀試驗(藥代動力學、有效性、安全性和免疫原性等比對研究)比對研究結果均與原研藥類克®高度相似。
類克®於1998年在美國上市,2007年進入中國市場,2020年全球銷售額為41.95億美元(數據來源:EvaluatePharma)。國內目前僅有泰州邁博太科藥業有限公司的英夫利西單抗生物類似藥上市。
根據海正藥業、海正藥業(杭州)有限公司與太盟簽訂的《浙江海正博鋭生物製藥有限公司股權轉讓合同》,博鋭生物或其全資子公司依法獲發其名下的注射用英夫利西單抗註冊證書,完成股權轉讓合同中里程碑補償款和特殊轉移補償款中的英夫利西特定事件,不會觸發英夫利西特定事件對太盟的現金補償義務。海正藥業合併層面因此將確認投資收益1.75億元,同時終止確認對應金額的其他非流動負債。
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