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貝達藥業(300558.SZ):EYP-1901玻璃體內植入劑病理性近視脈絡膜新生血管(pmCNV)適應症藥品臨牀試驗申請獲批開展

格隆匯7月27日丨貝達藥業(300558.SZ)公佈,今日,貝達藥業股份有限公司收到國家藥品監督管理局(簡稱“NMPA”)簽發的《藥物臨牀試驗批准通知書》(通知書編號:2023LP01498、2023LP01499),公司由EyePoint Pharmaceuticals, Inc.(NASDAQ:EYPT,簡稱“EyePoint”)引進的EYP-1901玻璃體內植入劑病理性近視脈絡膜新生血管(pmCNV)適應症藥品臨牀試驗(簡稱“該臨牀試驗”)申請已獲得NMPA批准開展。

伏羅尼布是具有全新化學結構的新一代多靶點酪氨酸激酶血管內皮生長因子受體(VEGFR)/血小板衍化生長因子受體(PDGFR)抑制劑,可抑制腫瘤血管生成及生長,可用於治療病理性血管生成性疾病。伏羅尼布片用於治療腎癌的適應症已於2023年6月獲批上市。

截至公吿披露日,全球範圍內抗VEGF類眼科藥物中尚無EYP-1901同類小分子植入劑品種獲批上市。

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