神州細胞(688520.SH):神州細胞工程的瑞帕妥單抗注射液(商品名:安平希®)獲批上市
格隆匯8月31日丨神州細胞(688520.SH)公佈,公司的控股子公司神州細胞工程有限公司(簡稱“神州細胞工程”)已獲得國家藥品監督管理局於2022年8月23日核准簽發的瑞帕妥單抗注射液(商品名:安平希®)的《藥品註冊證書》,適用於新診斷CD20陽性瀰漫大B細胞性非霍奇金淋巴瘤(DLBCL)成人患者。
安平希®為神州細胞工程研製的抗CD20單克隆抗體,通用名為瑞帕妥單抗注射液(項目代號:SCT400),用於治療新診斷CD20陽性瀰漫大B細胞性非霍奇金淋巴瘤(DLBCL)成人患者。
淋巴瘤主要可分為非霍奇金淋巴瘤和霍奇金淋巴瘤兩類,其中非霍奇金淋巴瘤佔比約為90%,而在我國約94.5%的非霍奇金淋巴瘤患者為CD20陽性。安平希®通過與B細胞上的跨膜抗原CD20結合,以啟動多種機制介導的免疫反應來殺傷B細胞淋巴瘤,包括CDC(補體介導的細胞殺傷毒性)、ADCC(抗體介導的細胞殺傷毒性)、細胞凋亡和交聯等機制協同抑制腫瘤細胞生長。獲批上市後,安平希®將提高CD20抗體藥物的可及性,惠及適合使用CD20抗體治療的患者。
截至公吿披露日,國內已獲批上市的CD20抗體藥物包括羅氏製藥的美羅華®、佳羅華®以及兩款美羅華®的生物類似藥(信達生物的達伯華®和復宏漢霖的漢利康®)。根據IQVIA數據庫顯示,2021年度CD20抗體中國境內的銷售額約為人民幣31.56億元。
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