綠葉製藥(02186.HK)新一代NTRK抑制劑獲批進入臨牀 有望改善NTRK基因融合突變治療耐藥性
綠葉製藥集團宣佈，其發現合成的、具有自主知識產權的全新1類NTRK小分子抑制劑——LPM4870108片(LY01018)的臨牀試驗申請，已獲得中國國家藥品監督管理局藥品審評中心的批准，進入臨牀階段。LPM4870108用於治療不同腫瘤類型的NTRK融合陽性癌症患者以及對於第一代NTRK抑制劑產生耐藥性的患者。
NTRK基因融合是明確的致癌驅動因素，廣泛分佈於不同類型的癌症中，在包括肺癌、結直腸癌、甲狀腺瘤、纖維肉瘤等20多種成人和兒童的實體瘤中被發現。第一代NTRK同靶點已上市產品被業界視為靶向精準的“廣譜”抗癌藥，它基於腫瘤遺傳學、而非腫瘤的原發部位來治療癌症，為那些尤其已處於晚期或已轉移的、缺少其他有效治療方案的實體腫瘤病人帶來新的治療希望。
然而遺憾的是，大部分NTRK融合陽性癌症患者在使用第一代NTRK同靶點已上市產品治療一段時間後，相繼出現了獲得性耐藥突變，主要包括NTRK1-G595R、NTRK2-G639R、NTRK3-G623R等，而目前尚未有針對上述突變的第二代抑制劑獲批上市。
LPM4870108是綠葉製藥發現合成的以及高選擇性的第二代NTRK抑制劑，對野生型和獲得耐藥型突變均有效，擬用於治療“NTRK基因融合及其耐藥突變陽性的實體瘤患者”。LPM4870108預計可覆蓋已上市的第一代同靶點產品的全部相關適應症，同時也涵蓋第一代抑制劑先天耐藥或用藥後獲得性耐藥患者的治療，即包括NTRK基因融合實體瘤患者的一線和二線治療，適應症範圍更為廣泛。
綠葉製藥集團管理層表示：“腫瘤治療的發展日新月異，各種創新療法的演進和突破為廣大患者帶來了更多、更新的治療選擇，幫助他們獲得更長久的生存和更高質量的生活。綠葉製藥長期深耕腫瘤治療領域，希望針對這些亟需滿足的臨牀需求，為腫瘤患者提供更多創新藥物，幫助他們獲得更好的臨牀獲益。”
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