博安生物(06955.HK):BA1302獲美國FDA鱗狀非小細胞肺癌和胰腺癌孤兒藥資格認定
格隆匯3月26日丨博安生物(06955.HK)公告,公司自主研發的靶向CD228創新抗體偶聯藥物BA1302已獲得美國食品藥品監督管理局(FDA)授予鱗狀非小細胞肺癌和胰腺癌兩個適應症的孤兒藥資格認定(Orphandrug Designation,ODD)。BA1302爲中國首個進入臨牀階段、全球唯一處於臨牀階段的靶向CD228創新抗體偶聯藥物(ADC),擬用於多種實體瘤的治療。
孤兒藥又稱爲罕見病藥,指用於預防、治療、診斷罕見病的藥品。BA1302此次獲得孤兒藥資格認定,將利於其後續在美國的研發、註冊及商業化等方面獲得相關政策支持,並將有助於降低研發投入、加快臨牀開發及上市進度,填補亟待滿足的治療需求。
BA1302的抗體篩選自公司自有知識產權的全人抗體轉基因小鼠平臺BAhuMab,具有僅結合膜形式的CD228而不結合其可溶形式sMFI2的優點,減少了載荷在非靶細胞中的釋放,脫靶毒性低。BA1302採用半胱氨酸偶聯技術,具有優異的體內外穩定性和抗腫瘤活性。
公司現有BA1302和BA1301(靶向Claudin18.2)兩款ADC產品正在開展臨牀試驗。此外,還有包括雙抗ADC在內的多款創新產品處於臨牀前研發階段。
公司認爲,BA1302在泛實體瘤中展現出優異的單藥成藥潛力和聯合開發價值,呈現廣闊的臨牀應用前景。
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