海正藥業(600267.SH)：“注射用英夫利西單抗”的上市申請獲受理
格隆匯5月11日丨海正藥業(600267.SH)公佈，公司於2019年6月21日召開的第八屆董事會第三次會議及於2019年7月8日召開的2019年第二次臨時股東大會審議通過了《關於控股子公司浙江海正博鋭生物製藥有限公司實施增資擴股及老股轉讓的議案》，同意公司控股子公司浙江海正博鋭生物製藥有限公司(“海正博鋭”)通過引進社會資本的方式對其實施增資擴股及部分老股轉讓。上述事項委託台州市產權交易所有限公司公開掛牌實施。2019年9月4日，產權交易所確認PAG Highlander (HK) Limited(“太盟”)摘牌。
近日，海正博鋭全資子公司海正生物製藥有限公司(“海正生物”)收到國家藥品監督管理局簽發的“注射用英夫利西單抗”上市申請的《受理通知書》。
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。劑型為注射劑，規格為100mg。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®分別於1998年和1999年獲得美國食品藥品管理局(FDA)和歐洲醫藥審評管理局(EMEA)批准上市，2007年進入中國市場，目前在全球85個國家和地區已有超過百萬的患者接受了類克®的治療，擁有20餘年的安全使用經驗。類克®在中國獲批的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、銀屑病及成人潰瘍性結腸炎。2019年全球銷售額為43.8億美元。目前尚未有注射用英夫利西單抗生物類似藥在國內上市。
截至目前，注射用英夫利西單抗研發項目已投入1.1億元人民幣左右。
該項目後續將接受國家藥品審評中心的技術審評、臨牀試驗現場核查、藥品註冊生產現場檢查等事宜，海正生物將積極做好有關準備工作。
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》，如海正博鋭或其全資子公司依法獲發其名下的英夫利西單抗藥品註冊證，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單抗特定事件，則不會觸發英夫利西單抗特定事件對太盟的現金補償義務。
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