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科倫藥業(002422.SZ):蘋果酸舒尼替尼膠囊獲批
格隆匯 03-24 11:54

格隆匯3月24日丨科倫藥業(002422.SZ)宣佈,公司子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品蘋果酸舒尼替尼膠囊(12.5mg)的《藥品註冊證書》。

蘋果酸舒尼替尼膠囊由輝瑞研發,2006年在美國首獲批,後相繼在日本、歐盟等多個國家及地區獲批上市,2007年國內批准進口,用於不能手術的晚期腎細胞癌、甲磺酸伊馬替尼治療失敗或不能耐受的胃腸間質瘤及不可切除的轉移性高分化進展期胰腺神經內分泌瘤。

舒尼替尼為多靶點小分子酪氨酸激酶抑制劑,具有抗腫瘤血管生成與抑制腫瘤細胞增殖的雙重抗腫瘤效應,為全球首個可將腎癌患者的總生存期提高到2年以上的小分子靶向藥,目前已被美國NCCN《腎癌臨牀實踐指南(2021.V1)》、中國CSCO《腎癌診療指南2020》、《胃腸間質瘤全程化管理中國專家共識(2020版)》等國內外權威指南和專家共識推薦作為腎癌的一線及胃腸間質瘤的二線治療藥物。蘋果酸舒尼替尼膠囊為2020年國家醫保乙類品種,2019年中國銷售額4.7億元。

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)3個抗腫瘤藥物獲批上市,已在腫瘤領域形成初步的產品集羣。此次公司蘋果酸舒尼替尼膠囊獲批,以及後續系列品種的續貫獲批,將進一步豐富公司在腫瘤領域的產品管線。

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