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基石藥業-B(02616.HK):洛拉替尼針對ROS1陽性晚期非小細胞肺癌在中國臨試申請獲NMPA受理
格隆匯 10-20 08:08

格隆匯10月20日丨基石藥業-B(02616.HK)發佈公吿,洛拉替尼(lorlatinib,曾用名:勞拉替尼)針對cros oncogene 1 (“ROS1”)陽性晚期非小細胞肺癌(“NSCLC”)的臨牀試驗申請(“IND”)已獲中國國家藥品監督管理局(“NMPA”)受理。該研究旨在評估洛拉替尼在ROS1陽性晚期 NSCLC患者中的抗腫瘤活性和安全性,同時也是全球首個洛拉替尼治療ROS1陽性NSCLC的關鍵性研究。

洛拉替尼是一種具中樞神經系統(“CNS”)穿透力的針對ROS1及間變性淋巴瘤激酶(“ALK”) 的第三代酪氨酸激酶抑制劑(“TKI”)。憑藉其在CROWN研究(一項比較洛拉替尼和克唑替尼用於未經治療的ALK陽性NSCLC一線治療的療效和安全性的頭對頭研究)的驚豔數據,洛拉替尼已獲美國食品藥品監督管理局(“FDA”)批准,用於一線治療經FDA批准的檢測方法確認為 ALK陽性轉移性NSCLC成人患者。輝瑞在中國開展了洛拉替尼針對ALK陽性肺癌的多項臨牀研究,並於2021年3月遞交ALK陽性晚期NSCLC的新藥上市申請。 2021年6月,基石藥業宣佈與輝瑞在大中華地區針對ROS1陽性NSCLC開展合作研究,共同開發洛拉替尼,這是繼去年基石藥業與輝瑞達成戰略合作後,雙方合作的進一步深化。

基石藥業首席醫學官楊建新博士表示:“目前在全球範圍內,ROS1陽性NSCLC患者出現克唑替尼耐藥後,缺乏有效治療手段。我們非常高興的看到洛拉替尼在中國的IND獲得NMPA受理。我們將迅速推進洛拉替尼的臨牀研究,力爭早日滿足這部分患者的巨大未被滿足治療需求。同時我們也將繼續和輝瑞展開緊密合作,在癌症領域為廣大患者帶來更多治療選擇。”

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