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華東醫藥 (000963.SZ):全資子公司收到藥品註冊受理通知書
格隆匯 05-12 16:58

格隆匯5月12日丨華東醫藥 (000963.SZ)公佈,2024年5月11日,公司全資子公司杭州中美華東製藥有限公司(以下簡稱“中美華東”)收到國家藥品監督管理局(NMPA)簽發的《受理通知書》(受理號:CXHS2400040、CXHS2400041),由中美華東作為申請人申報的邁華替尼片(邁瑞東®,Mifanertinib Tablets)用於表皮生長因子受體(EGFR)21號外顯子L858R置換突變的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的一線治療的上市許可申請獲得受理。

邁華替尼片為一款新型、強效、高選擇性、具有口服活性的不可逆EGFR/人表皮生長因子受體-2(HER2)小分子抑制劑,是全新的、擁有自主知識產權的國家1類創新藥。邁華替尼通過與EGFR(ErbB1)和HER2(ErbB2)的激酶區域共價結合,不可逆地抑制酪氨酸激酶自磷酸化,導致ErbB信號下調,從而抑制腫瘤生長。

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