康方生物-B:國家藥品監督管理局受理派安普利單抗(安尼可)注射液的新藥上市申請
uSMART友信智投5月26日消息,週二早上,康方生物在披露易發佈《內幕消息--國家藥品監督管理局受理派安普利單抗(安尼可)注射液的新藥上市申請》公告,以下為公告原文:
本公司董事會欣然宣佈,國家藥品監督管理局(「NMPA」)已受理與中國生物製藥有限公司(1177.HK)共同開發及商業化的抗PD-1單抗藥物派安普利單抗(安尼可)(通用名:派安普利,研發代號:AK105)的新藥上市申請,用於治療至少經過二線系統化療復發或難治性(r/r)經典型霍奇金淋巴瘤(r/r cHL)患者。NMPA已於2020年5月25日在其網站上公佈受理申請。
關於經典型霍奇金淋巴瘤
經典型霍奇金淋巴瘤是一種B細胞惡性淋巴瘤,也是年輕人最常見的惡性腫瘤,在中國年齡-發病率曲線呈單峰,發病率高峰在40歲左右。cHL是少數可治癒的腫瘤之一,通常採用的治療方法為化療加放射治療,患者5年生存率可以達到80%以上。儘管一線化療具有較高的臨床治癒率,但仍有相當一部分患者對化療不敏感,大約5%-10%的患者對於初始治療無反應。


圖片來源:披露易
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