貝達藥業(300558.SZ):伏羅尼布片(CM082片)藥品註冊申請獲NMPA受理
格隆匯1月14日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥監局(簡稱“NMPA”)簽發的《受理通知書》(受理號:CXHS2200003國),公司申報的伏羅尼布片(CM082片,簡稱“伏羅尼布”)與依維莫司聯合擬用於治療既往接受過抗血管酪氨酸激酶抑制劑治療失敗的晚期腎細胞癌(RCC)患者的上市許可申請已獲得NMPA受理。
伏羅尼布是具有全新化學結構的新一代多靶點激酶抑制劑,可抑制腫瘤血管生成及生長,用於多種癌症的治療。伏羅尼布針對VEGFR、PDGFR等多靶點具有抗血管生成的顯著療效,並且能夠滿足靶點的特殊藥代動力學(PK)或藥效學(PD)要求,達到保留活性,降低毒性的目的。公司通過全資子公司卡南吉醫藥科技(上海)有限公司擁有伏羅尼布全部適應症的中國權益;通過控股子公司Xcovery Holdings, Inc.擁有伏羅尼布腫瘤適應症的海外權益,通過控股子公司Equinox Science, LLC擁有伏羅尼布眼科適應症的海外權益。
截至該公吿披露日,全球已有五款批准及上市的針對VEGFR和PDGFR靶點的用於治療RCC的抗VEGFR/PDGFR激酶抑制劑,包括索拉非尼、舒尼替尼、培唑帕尼、阿昔替尼及侖伐替尼。
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