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奧賽康(002755.SZ):注射用培美曲塞二鈉通過一致性評價
格隆匯 03-12 08:28

格隆匯3月12日丨奧賽康(002755.SZ)宣佈,公司的全資子公司江蘇奧賽康藥業有限公司於近日收到國家藥監局核准簽發的注射用培美曲塞二鈉(100mg500mg)《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。

培美曲塞是一種多靶點抗癌葉酸拮抗劑,通過破壞細胞複製所必須的關鍵的葉酸依賴性代謝過程,從而抑制細胞複製。培美曲塞由美國禮來製藥公司研發,於2004年在美國和歐盟上市,2007年在日本上市,2006年在我國進口上市。我公司研製的注射用培美曲塞二鈉(奧天成®)於2009年在國內上市,與順鉑聯合,用於治療局部晚期或者轉移性非鱗狀細胞型非小細胞肺癌或無法手術的惡性胸膜間皮瘤;或單藥用於既往接受一線化療後出現進展的局部晚期或轉移性非鱗狀細胞型非小細胞肺癌患者的治療。

肺癌是世界上發病率和致死率最高的惡性腫瘤,在中國超過85%的肺癌為非小細胞肺癌,超過65%的肺癌患者在診斷時已發展為晚期,不適合手術切除,超過50%的早期肺癌患者1年後出現局部復發或遠處轉移。培美曲塞作為新一代抗代謝類化療藥物,具有高效、低毒、廣譜的抗腫瘤活性,對肺癌、惡性胸膜間皮瘤、乳腺癌、胰腺癌和胃腸道腫瘤均有明確的治療效果。PDB數據庫顯示2019年中國樣本醫院銷售額達16億元,市場潛力大。

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