天士力(600535.SH):注射用硼替佐米獲得藥品註冊證書
格隆匯9月6日丨天士力(600535.SH)公佈,近日,公司之全資子公司江蘇帝益收到國家藥品監督管理局核准簽發的關於注射用硼替佐米的《藥品註冊證書》。藥品名稱:注射用硼替佐米;適應症:多發性骨髓瘤、套細胞淋巴瘤。
注射用硼替佐米於2020年5月完成生產驗證,於2021年2月申報CDE技術評審,並於近日獲得國家藥監局核准簽發的《藥品註冊證書》。截至目前,江蘇帝益對該項目的累計研發投入為1669.15萬元人民幣。
硼替佐米是一種雙肽基硼酸鹽類似物,是全球第一個人工合成的用於臨牀的新型蛋白酶體競爭性抑制劑,作為抗腫瘤用藥之一,用於多發性骨髓瘤和套細胞淋巴瘤的治療。注射用硼替佐米(3.5mg/瓶)原研藥由Janssen-Cilag International N.V.持有,商品名為“VELCADE”(萬珂),於2003年5月獲得美國FDA批准上市,2004年4月在歐盟授權上市,2005年2月獲NMPA批准進入中國市場。
多發性骨髓瘤是全球第二大常見血液癌症,硼替佐米作為第一代蛋白酶體抑制劑具有抑制腫瘤細胞生長、誘導細胞凋亡和抑制血管新生作用,成為治療該類疾病的首選藥物。自2017年該藥被《中國多發性骨髓瘤診治指南》列為多發性骨髓瘤全程管理的一線用藥,並被納入《國家基本醫療保險、工傷保險和生育保險藥品目錄》(乙類品種)。
米內網化學藥醫療終端數據顯示國內城市公立、縣級公立2021年度注射用硼替佐米銷售額為12.82億元人民幣,其中原研藥佔比為38.27%。目前中國境內已上市的注射用硼替佐米除原研進口外,還包括齊魯製藥有限公司等9家仿製藥企業。
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