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中國生物製藥(01177.HK):"注射用鹽酸苯達莫司汀"獲藥品註冊批件
格隆匯 12-11 18:08

格隆匯12月11日丨中國生物製藥(01177.HK)公告,公司附屬公司正大天晴藥業集團股份有限公司開發的抗腫瘤藥"注射用鹽酸苯達莫司汀",已獲中華人民共和國國家藥品監督管理局頒發藥品註冊批件。該產品適用於治療利妥昔單抗或含利妥昔單抗方案治療過程中或者治療後病情進展的惰性B細胞非霍奇金淋巴瘤。該產品是按照化藥新3類申報,視同通過仿製藥質量和療效一致性評價,國內首仿獲批。這一重磅產品獲批上市,將進一步豐富和完善本集團血液腫瘤產品線佈局。

鹽酸苯達莫司汀是一種雙功能基烷化劑,具有抗腫瘤和殺細胞作用。作為新一代抗癌藥物,鹽酸苯達莫司汀具有毒性低,活性高,抗瘤譜廣,患者易耐受、可長期使用的特點。鹽酸苯達莫司汀單藥或聯合治療方案已被歐美臨牀指南指定為多種血液系統惡性腫瘤的一線或二線治療選擇。目前國內只有進口注射用鹽酸苯達莫司汀上市。

集團開發的注射用鹽酸苯達莫司汀,處方組成與原研產品相同,療效與原研產品相當;日後上市,將可降低患者治療成本,減輕其用藥的經濟壓力。

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