恆瑞醫藥(600276.SH)：馬來酸吡咯替尼片獲批臨牀試驗
格隆匯12月3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。
審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2019年9月11日受理的馬來酸吡咯替尼片符合藥品註冊的有關要求，同意批准本品開展臨牀試驗。
2019年9月11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聯合曲妥珠單抗加多西他賽對比安慰劑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。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。
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®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，規格為40mg片；2018年9月向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，2018年Tykerb®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1327萬美元。
截至目前，該產品項目已投入研發費用約70763萬元人民幣。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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