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中國生物製藥(01177.HK):LM-350"CDH17 ADC"獲得美國FDA的IND批件
格隆匯 07-24 16:34

格隆匯7月24日丨中國生物製藥(01177.HK)宣佈,集團全資附屬公司禮新醫藥科技(上海)有限公司("禮新醫藥")自主研發的創新藥LM-350"CDH17 ADC"已獲得美國食品藥品監督管理局("FDA")的新藥臨牀試驗(IND)批件。

LM-350是基於禮新醫藥新一代抗體偶聯藥物(ADC)平台LM-ADCTM開發的一款靶向CDH17的ADC,能夠高度選擇性地結合CDH17,具有很強的內化能力。LM-350採用IgG1野生型構型,同時具備抗體依賴細胞介導的細胞毒性作用(ADCC)活性。臨牀前研究顯示,LM-350在多個異種移植模型中表現出顯著的抗腫瘤活性,尤其在對MMAE耐藥或伊立替康耐藥的結直腸癌細胞中效果突出。

CDH17在多種腫瘤侵襲轉移中發揮重要作用,並在約99%的結腸癌、86%的胃腺癌、79%的食管腺癌、50%的胰腺導管腺癌中高表達。消化道腫瘤(包括結直腸癌、胃癌、胰腺癌、食管癌等)是全球發病率和死亡率最高的癌症種類之一,2022年全球新發患者數量超過400萬人,存在巨大的尚未被滿足的臨牀需求。

除LM-350外,本集團還有5款ADC產品位臨牀階段,包括:TQB2102 (HER2雙抗ADC)位臨牀III期、LM-302 (Claudin 18.2 ADC)位臨牀III期、LM-305 (GPRC5D ADC)位臨牀I/II期、TQB2101 (ROR1 ADC)位臨牀I期、TQB6411 (EGFR/c-Met ADC)位臨牀I期,以及近10款ADC產品位臨牀前,預計將在未來1-2年內進入臨牀階段。

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