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翰森製藥(03692.HK)"培化西海馬肽注射液"上市許可申請獲國家藥品監督管理局受理
格隆匯 10-04 17:14

格隆匯10月4日丨翰森製藥(03692.HK)公吿,由公司附屬公司江蘇豪森藥業集團有限公司開發的1類創新藥"培化西海馬肽注射液"上市許可申請獲中華人民共和國國家藥品監督管理局("NPMA")受理,擬用於治療因慢性腎臟病(CKD)引起貧血,且正在接受促紅細胞生成素治療的透析患者。

"培化西海馬肽注射液"是江蘇豪森藥業集團有限公司自主研發的1類創新藥,是一種長效的新型多肽類促紅細胞生成素(EPO)激動劑。在經促紅素治療的CKD透析貧血患者中進行的關鍵III期臨牀研究結果表明,"培化西海馬肽注射液"研究達到主要療效終點,呈現優效性;在健康受試者和腎性貧血患者中具有良好的安全性和耐受性;在CKD人羣中"培化西海馬肽注射液"相較利血寶(重組促血紅素注射液(CHO細胞))未增加心血管事件風險,並有潛在的安全性優勢,患者依從性良好。

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