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騰盛博藥-B(02137.HK):BRII-835和BRII-877獲得突破性治療品種認定
格隆匯 05-14 07:23

格隆匯5月14日丨騰盛博藥-B(02137.HK)發佈公吿,中國國家藥品監督管理局藥品審評中心將在研的乙型肝炎病毒(“HBV”)特異性廣譜中和單克隆抗體BRII-877(tobevibart)和在研的HBV靶向小干擾核糖核酸BRII-835(elebsiran)納入突破性治療品種。這是繼2023年11月基於重組蛋白的HBV免疫療法BRII-179獲得突破性治療品種認定之後,公司在尋求HBV功能性治癒方面取得的又一個里程碑。

公司中國研發負責人朱青博士表示:“BRII-835和BRII-877獲得突破性治療品種認定,以及BRII-179早前獲得突破性治療品種認定,進一步支持了我們長期以來為慢性HBV感染患者開發功能性治癒聯合療法的科學依據。在過去的五年中,本公司和我們的合作伙伴Vir進行了大量的臨牀試驗,我們從中獲得了非常全面的臨牀安全性和有效性數據,並對我們的後期開發計劃,以及在更廣泛的患者羣體中實現更高的HBV功能性治癒率有了透徹的認識。”

擁有三種突破性治療手段,使公司在應對更廣泛的HBV感染(包括合併HDV感染)方面處於獨特的地位。作為公司開發HBV功能性治癒療法的一部分,公司及其合作伙伴Vir正在推進於2024年啟動多項聯合研究的計劃,以進一步優化治療方案,為公司的註冊戰略提供依據,從而為HBV患者提供最佳治療方案。 

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