三生製藥(01530.HK)重組人血小板生成素注射液(特比澳)兒童ITP適應症獲批
格隆匯4月12日丨三生製藥(01530.HK)公吿,公司向國家藥品監督管理局(NMPA)提交的三生製藥重組人血小板生成素注射液(特比澳)新適應症已於4月2日獲得批准,用於治療兒童或青少年的持續性或慢性原發免疫性血小板減少症(ITP)。
特比澳是由三生製藥自主研製的重組人血小板生成素(Recombinant Human Thrombopoietin, rhTPO)注射液,此前已獲批成人實體瘤化療後血小板減少症(CIT)和成人原發免疫性血小板減少症(ITP)適應症。目前,重組人血小板生成素注射液是中國ITP指南推薦首選的二線治療藥物。
原發免疫性血小板減少症(ITP)是一種獲得性自身免疫性出血性疾病,兒童ITP常表現為平時體健的兒童突發瘀點、瘀斑或出血,偶有患者因其他情況行全血細胞計數時發現血小板減少。此前為滿足兒童ITP臨牀治療需求,響應國家開發兒童應用藥物的號召,三生製藥在全國共10家兒童醫院及綜合性醫院啟動開展了其兒童ITP適應症的Ⅲ期臨牀研究,試驗主要療效指標為總體有效率。
三生製藥董事長兼首席執行官婁競博士表示:“特比澳在長期的臨牀實踐中已經被證明值得信賴,我們相信其在兒童ITP患者的治療中也將繼續發揮出色的表現。兒童ITP適應症的獲批將提高其在兒科臨牀中的可及性,更好地滿足我國兒童ITP患者的臨牀治療需求。未來,三生製藥仍將持續致力於高質量生物藥的研究及開發,為更多患者及家庭造福”。
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