信達生物(01801.HK):NMPA受理達伯舒®聯合貝伐珠單抗注射液及化療用於治療經EGFR-TKI治療失敗的EGFR基因突變陽性非鱗狀非小細胞肺癌患者的新適應症上市申請
格隆匯12月24日丨信達生物(01801.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已經正式受理創新PD-1抑制劑達伯舒®(信迪利單抗注射液)聯合貝伐珠單抗注射液及化療(培美曲塞+順鉑)治療經表皮生長因子受體(“EGFR”)酪氨酸激酶抑制劑(“TKI”)治療失敗的EGFR基因突變陽性的局部晚期或轉移性非鱗狀非小細胞肺癌(“nsqNSCLC”)的新適應症上市申請(“sNDA”)。
根據披露,肺癌是全球死亡率最高的惡性腫瘤,其發病率位居全球惡性腫瘤發病率的第二位。在所有肺癌中非小細胞肺癌(“NSCLC”)大約佔80%至85%,約70%的NSCLC患者在診斷時已是不適於手術切除的局部晚期或轉移性疾病。中國NSCLC患者中約70%為nsqNSCLC,其中EGFR突變的nsqNSCLC患者大約佔40%至50%,該類患者一線標準治療推薦三代EGFR-TKI,或一、二代EGFR-TKI,但在EGFR-TKI治療進展後的治療選擇及療效仍十分有限,存在着巨大的未滿足的臨牀需求。
ORIENT-31是全球首個前瞻性、雙盲3期研究證實免疫聯合抗血管生成藥物及化療可以使該部分患者羣體PFS獲益得到延長,也意味着信迪利單抗在多個大癌種適應症上的探索取得又一重要進展。公司將積極配合國內監管機構,希望推動該適應症早日獲批,惠及更多肺癌患者。
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