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恆瑞醫藥(600276.SH):馬來酸吡咯替尼片獲批臨牀試驗
格隆匯 08-26 16:08

格隆匯8月26日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗,藥品名稱為馬來酸吡咯替尼片。

20188月,公司及子公司上海恆瑞醫藥有限公司收到國家藥監局核准籤發的馬來酸吡咯替尼片《新藥證書》和《藥品註冊批件》。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、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,使用本品前患者應接受過蒽環類或紫杉類化療。2019618日,公司向國家藥監局遞交本品臨牀試驗申請獲受理,具體為馬來酸吡咯替尼片治療HER2突變晚期非小細胞肺腺癌的有效性和安全性的II期臨牀研究。

經查詢,目前國外已上市用於乳腺癌治療的同類產品有Tykerb®lapatinib)和Nerlynx®neratinib)。Tykerb®GlaxoSmithKline公司開發,最早於20073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®Puma Biotechnology,Inc.公司開發,20177美國食品藥品監督管理局批准,規格為40mg20189國家藥監局提交上市申請,目前狀態為在審評審批中。經查詢IMS數據庫,2018Tykerb®全球銷售額約為1.7億美元,中國銷售額約為1078萬美元;Nerlynx®全球銷售額約為1327美元

截至目前,該產品項目已投入研發費用約6.745億元人民幣

根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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