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中國生物製藥(01177.HK)創新抗PD-L1注射液納入優先審評審批程序
阿思達克 02-08 02:52
中國生物製藥(01177.HK)公布,附屬正大天晴開發的「貝莫蘇拜單抗(TQB2450注射液)」已被中國國家藥品監督管理局藥品審評中心納入優先審評審批程序,用於聯合鹽酸安羅替尼膠囊治療復發性或轉移性子宮內膜癌。 貝莫蘇拜單抗是集團自主研發的一款全新序列的創新全人源化抗PD-L1單克隆抗體。2022年4月,其聯合安羅替尼治療復發性或轉移性子宮內膜癌被CDE納入突破性治療品種。2023年1月,其新藥上市申請獲CDE正式受理,用於聯合安羅替尼一線治療小細胞肺癌。
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