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恆瑞醫藥(600276.SH):二線後晚期胃癌藥物甲磺酸阿帕替尼片獲批臨試
格隆匯 10-24 15:49

格隆匯10月24日丨恆瑞醫藥(600276.SH)宣佈,公司及子公司上海恆瑞醫藥有限公司近日收到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。

2019年8月14日,恆瑞醫藥和上海恆瑞醫藥有限公司向國家藥監局遞交的0.25g、0.375g兩個規格的甲磺酸阿帕替尼片分別與依託泊苷膠囊聯用的臨牀試驗申請獲得受理,受理號分別為CXHL1900286、CXHL1900287。

甲磺酸阿帕替尼是恆瑞醫藥自主研發的一款小分子酪氨酸激酶抑制劑,它能夠選擇性地抑制血管內皮細胞生長因子受體2(VEGFR-2)的酪氨酸激酶活性,從而抑制腫瘤血管生成,抑制腫瘤生長。2014年12月,甲磺酸阿帕替尼片獲批用於二線化療失敗的晚期胃癌治療。

經查詢,甲磺酸阿帕替尼目前國內外有Solafeinib、Sunitinib等同類產品已獲批上市。Solafeinib由拜耳公司開發,最早於2005年在美國獲批上市;Sunitinib由輝瑞公司開發,最早於2006年在美國獲批上市。2018年甲磺酸阿帕替尼銷售額約為17億元人民幣。截至目前,相關項目已投入研發費用約為2.8146億元人民幣。

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