東誠藥業(002675.SZ)：擬用於治療FAP陽性表達的晚期實體瘤成年患者的相關藥品將於近期在新加坡開展I期臨牀試驗
格隆匯4月5日丨東誠藥業(002675.SZ)公佈，近日，公司下屬公司YANTAI LNC BIOTECHNOLOGY SINGAPORE PTE. LTD. (“藍納成新加坡”)收到新加坡衞生科學局(“HSA”)核准簽發的關於177Lu-LNC1004注射液的藥品臨牀試驗授權通知書，將於近期在新加坡開展I期臨牀試驗。
審批結論：HSA批准使用177Lu-LNC1004注射液和68Ga-FAPI-46注射液的臨牀試驗授權。
公司在研產品177Lu-LNC1004注射液是一種靶向成纖維細胞活化蛋白(Fibroblast Activation Protein，“FAP”)的放射性體內治療藥物，為全新靶點藥物，擬用於治療FAP陽性表達的晚期實體瘤成年患者，目前在國際和國內尚無同靶點治療藥物上市。
FAP為II型跨膜絲氨酸蛋白酶，高表達於許多上皮腫瘤相關成纖維細胞(Cancer-Associated Fibroblasts，“CAF”)中，包括胃癌、食管癌、肺癌、結直腸癌、卵巢癌等，而在正常組織、良性腫瘤間質中無表達或表達較低。LNC1004前體能特異性地與CAF膜表面的FAP結合，通過將放射性核素177Lu靶向運送至FAP陽性表達的實體瘤實現腫瘤的精準治療。通過臨牀前研究和IIT研究(investigator-initiated trial，研究者發起的臨牀研究)結果顯示，177Lu-LNC1004注射液能夠實現精準有效的殺傷胃癌、食管癌、肺癌、甲狀腺癌等實體腫瘤細胞，治療效果顯著。
177Lu-LNC1004注射液除了具有靶向治療的優勢外，其化學結構在經過伊文思藍(Evans Blue，“EB”)修飾後能夠改善探針的藥代和藥效性能，增加腫瘤對藥物的有效攝取，延長治療時間窗並可以在同等或更優的治療效果下降低放射性核素的用量，進而降低患者的治療成本。
目前國內外暫無同產品上市，亦無相關銷售數據。截至目前，177Lu-LNC1004注射液相關項目累計已投入研發費用約3253.66萬元。
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