恆瑞醫藥(600276.SH):獲得藥品補充申請批准通知書
格隆匯 7 月 20日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,藥品名稱為馬來酸吡咯替尼片。
根據《中華人民共和國藥品管理法》及有關規定,經審查,該品符合藥品註冊的有關要求,批准本品修訂説明書的補充申請,本品聯合卡培他濱,適用於治療表皮生長因子受體2(HER2)陽性、接受過曲妥珠單抗的復發或轉移性乳腺癌患者的適應症轉為完全批准。
經查詢,國外已上市用於乳腺癌治療的同類產品有Tykerb®(lapatinib)、Nerlynx®(neratinib)和Tukysa®(tucatinib)。Tykerb®由GlaxoSmithKline公司開發,最早於2007年3月獲美國食品藥品監督管理局批准,規格為250mg/片,國內已進口上市。Nerlynx®由Puma Biotechnology,Inc.公司開發,2017年7月獲美國食品藥品監督管理局批准,2020年5月獲得中國國家藥品監督管理局批准上市。Tukysa®由Seattle Genetics公司開發,2020年4月獲美國食品藥品監督管理局批准,規格為150mg/片。經查詢,2019年Tukysa®和Nerlynx®的全球銷售額約為4.03億美元。
截至目前,該產品累計已投入研發費用約79218萬元人民幣。
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