恆瑞醫藥(600276.SH):馬來酸吡咯替尼片的上市許可申請獲受理
格隆匯9月16日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(“藥監局”)下發的《受理通知書》(受理號:CXHS2101040、CXHS2101041),公司提交的馬來酸吡咯替尼片藥品上市許可申請獲藥監局受理。
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。
馬來酸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小分子抑製劑有 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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