恆瑞醫藥(600276.SH)：馬來酸吡咯替尼片被納入擬優先審評品種公示名單
格隆匯9月24日丨恆瑞醫藥(600276.SH)公佈，近日，公司的馬來酸吡咯替尼片被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單，公示期7日。
擬定適應症(或功能主治)：本品聯合曲妥珠單抗及多西他賽，適用於治療表皮生長因子受體2 (HER2)陽性早期或局部晚期乳腺癌患者的新輔助治療。
擬優先審評理由：經審核，本申請符合《藥品註冊管理辦法》和《國家藥監局關於發佈<突破性治療藥物審評工作程序(試行)>等三個文件的公吿》(2020年第82號)有關要求，同意按優先審評範圍“(五)符合附條件批准的藥品”納入優先審評審批程序。
2021 年 6 月，馬來酸吡咯替尼片聯合曲妥珠單抗加多西他賽術前治療早期或局部晚期 HER2 陽性乳腺癌的隨機、雙盲、平行對照、多中心的 III 期臨牀研究（HR-BLTN-III-NeoBC 研究），主要研究終點-總體病理完全緩解（tpCR）達到方案預設的優效標準（詳見公吿編號：臨 2021-080）。公司已提交馬來酸吡咯替尼片“聯合曲妥珠單抗及多西他賽，適用於治療表皮生長因子受體 2（HER2）陽性早期或局部晚期乳腺癌患者的新輔助治療”適應症的藥品上市許可申請，該藥品上市許可申請已獲國家藥品監督管理局受理（詳見公吿編號：臨 2021-130）。此次被納入優先審評程序，將有助於馬來酸吡咯替尼片“聯合曲妥珠單抗及多西他賽，適用於治療表皮生長因子受體 2（HER2）陽性早期或局部晚期乳腺癌患者的新輔助治療”適應症藥品註冊申請早日獲批，為乳腺癌患者提供一種新型的新輔助治療方案。
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。繼2018年8月獲得有條件批准上市後，馬來酸吡咯替尼片已於2020年7月獲得國家藥品監督管理局完全批准。本品聯合卡培他濱，適用於治療HER2陽性、既往未接受或接受過曲妥珠單抗的復發或轉移性乳腺癌患者，使用前患者應接受過蒽環類或紫杉類化療。目前國內外已上市用於乳腺癌治療的 EGFR/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，2020年Tykerb全球銷售額約1.68億美元、2020年 Nerlynx全球銷售額約2億美元、2020年Tukysa全球銷售額約1.2億美元。
截至目前，馬來酸吡咯替尼相關項目累計已投入研發費用約102277萬元。
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