恆瑞醫藥(600276.SH):收到臨牀試驗通知書
格隆匯1月21日丨恆瑞醫藥(600276.SH)公佈,公司及子公司蘇州盛迪亞生物醫藥有限公司、上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
申請事項:卡瑞利珠單抗聯合白蛋白紫杉醇加阿帕替尼、卡瑞利珠單抗聯合白蛋白紫杉醇對比白蛋白紫杉醇治療晚期三陰性乳腺癌的隨機、開放、平行對照、多中心的III期臨牀研究
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2019年10月31日受理的注射用卡瑞利珠單抗和2019年11月02日受理的甲磺酸阿帕替尼片符合藥品註冊的有關要求,同意批准本品開展臨牀試驗。
注射用卡瑞利珠單抗是人源化抗PD-1單克隆抗體,可與人PD-1受體結合並阻斷PD-1/PD-L1通路,恢復機體的抗腫瘤免疫力,從而形成癌症免疫治療基礎。經查詢,抗PD-1抗體國外目前有同類產品Nivolumab、Pembrolizumab已獲批上市。Nivolumab由BRISTOL MYERS SQUIBB公司開發,商品名為Opdivo,最早於2014年在美國獲批上市;Pembrolizumab由Merck Sharp & Dohme公司開發,商品名為Keytruda,最早於2014年在美國獲批上市。上述兩種藥品目前均已在國內獲批上市。國內目前信達生物和君實生物開發的同類抗PD-1單抗注射液於2018年獲批上市,百濟神州等企業的相關藥品正處於上市申請審批階段。經查詢,2018年抗PD-1抗體全球銷售額約為141.78億美元,國內銷售額約643.75萬美元。
甲磺酸阿帕替尼是公司創新研發的小分子靶向藥物,2014年獲批上市。經查詢,甲磺酸阿帕替尼目前國內外有Solafeinib、Sunitinib等同類產品已獲批上市。Solafeinib由拜耳公司開發,最早於2005年在美國獲批上市;Sunitinib由輝瑞公司開發,最早於2006年在美國獲批上市。2018年甲磺酸阿帕替尼銷售額約為17億元人民幣。
注射用紫杉醇(白蛋白結合型)由美國阿博利斯生命科學公司開發,最早於2005年獲得美國食品藥品監督管理局批准,英文商品名為Abraxane,現已在美國、歐盟、日本等多個國家和地區上市。經查詢,國內現有該藥品的進口藥和石藥集團的仿製藥獲批上市銷售,另有齊魯製藥、海正藥業、江蘇康禾等多家企業提交的註冊申請正在審評審批。2018年,注射用紫杉醇(白蛋白結合型)銷售額約11776萬元人民幣。
截至目前,注射用卡瑞利珠單抗、甲磺酸阿帕替尼、注射用紫杉醇(白蛋白結合型)三個項目的累計研發費用分別為74011萬元、33105萬元、4478萬元。
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