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普利製藥(300630.SZ):創新藥注射用PL002收到美國IND受理
格隆匯 10-15 16:18

格隆匯10月15日丨普利製藥(300630.SZ)公佈,公司全資子公司浙江普利藥業有限公司於近日收到了美國食品藥品監督管理局(以下簡稱“FDA”)簽發的注射用PL002創新藥臨牀試驗申請(IND)的受理通知。

PL002是浙江普利藥業有限公司研發的熒光/磁共振雙模態造影劑,開發熒光/磁共振雙模態造影劑成為提高原發性肝癌手術效率的有效方案。雙模態造影劑的熒光成像能力可用於肝癌術中熒光導航,而磁共振增強能力可用於在術前判斷肝臟代謝能力,推測腫瘤及肝臟對造影劑的攝取情況,提高腫瘤診斷精度,降低術前規劃難度。

相關研究表明吲哚菁綠(ICG)在肝臟腫瘤內富集主要依靠有機陰離子轉運體(OATP1B3)和Na+-牛磺膽酸鹽共轉運多肽(NTCP),類似的PL002體外研究發現其與OATP1B3有明顯相互作用,與ICG性質一致,可能具有相同的轉運通路。且本品主要經肝臟排泄,因此可以對肝臟腫瘤特異性增強,為原發性肝癌手術的術前診斷及術中導航提供更為充分的數據及新的選擇。創新藥注射用PL002的成功研發將豐富公司造影劑領域產品,並對公司拓展造影劑市場帶來積極影響。同時,公司注射用PL002其他市場的新藥臨牀試驗申請工作也在持續推進中。

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