科倫藥業(002422.SZ):鹽酸厄洛替尼片獲批上市
格隆匯6月21日丨科倫藥業(002422.SZ)公佈,公司子公司湖南科倫製藥有限公司的化學藥品“鹽酸厄洛替尼片”於近日獲得國家藥品監督管理局的藥品註冊批准。
鹽酸厄洛替尼片為羅氏開發的表皮生長因子酪氨酸激酶抑制劑(EGFR-TKI),2004年美國首獲批,後相繼在歐盟、日本等多個國家獲批上市,2006年國內批准進口,用於EGFR基因敏感突變的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療。
厄洛替尼為第一代EGFR-TKI,較傳統化療可顯著改善EGFR突變NSCLC患者的無進展生存期(PFS),為目前唯一可聯合雷莫蘆單抗或貝伐珠單抗進一步延長患者PFS的EGFR-TKI,且能透過血腦屏障,有效防控腦轉移,已被美國NCCN《非小細胞肺癌臨牀實踐指南(2021.V4)》、歐洲ESMO《轉移性非小細胞肺癌臨牀實踐指南2020》及中國CSCO《非小細胞肺癌診療指南2020》等國內外權威指南推薦作為EGFR突變NSCLC的一線治療方案。鹽酸厄洛替尼片為2020年國家醫保乙類品種,2020年中國銷售3.4億元。
目前公司已有吉非替尼片、唑來膦酸注射液(4mg/100ml)、注射用紫杉醇(白蛋白結合型)、蘋果酸舒尼替尼膠囊、馬來酸阿法替尼片5個抗腫瘤藥物獲批,已在腫瘤領域形成初步的產品集羣。此次公司鹽酸厄洛替尼片獲批,將進一步豐富公司在腫瘤領域的產品管線。
2015年國家藥監政策改革,要求新申報的仿製藥必須與原研質量和療效一致。公司此次獲批的鹽酸厄洛替尼片即是按照這一要求研發。藥監局公佈的參比制劑信息如下:商品名:Tarceva,持證商:Roche Registration Limited/ Roche Registration GmbH。
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