恆瑞醫藥(600276.SH):馬來酸吡咯替尼片擬納入優先審評程序
格隆匯11月17日丨恆瑞醫藥(600276.SH)公佈,近日,公司藥品馬來酸吡咯替尼片被國家藥品監督管理局藥品審評中心(簡稱“藥審中心”)擬納入優先審評品種公示名單,公示期7日。
藥品名稱:馬來酸吡咯替尼片;擬定適應症(或功能主治):本品與曲妥珠單抗和多西他賽聯合,適用於治療表皮生長因子受體2(HER2)陽性、晚期階段未接受過抗HER2治療的復發或轉移性乳腺癌患者。
吡咯替尼是一種小分子、不可逆、泛ErbB受體酪氨酸激酶抑制劑。目前國內外已上市用於乳腺癌治療的HER2小分子抑制劑有Lapatinib(商品名Tykerb)、Neratinib(商品名Nerlynx)和Tucatinib(商品名Tukysa)。經查詢EvaluatePharma數據庫,2021年Lapatinib、Neratinib、Tucatinib全球銷售額合計約為6.87億美元。
截至目前,馬來酸吡咯替尼片相關項目累計已投入研發費用約為11.48億元。
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