海普瑞(09989.HK):全人源單克隆抗體藥物(AR-301)III期藥品臨牀試驗補充申請獲國家藥監局批准
格隆匯6月1日丨海普瑞(09989.HK)公吿,近日,深圳市海普瑞藥業集團股份有限公司(以下簡稱“公司”)控股子公司深圳市瑞迪生物醫藥有限公司(以下簡稱“瑞迪生物”)收到通知,其全人源單克隆抗體藥物(AR-301)的III期藥品臨牀試驗補充申請已獲中國國家藥品監督管理局批准。
AR-301是一種針對革蘭氏陽性金黃色葡萄球菌(以下簡稱“金葡菌”)釋放的α-毒素的全新的全人源單克隆IgG1抗體,擬用於金葡菌引起的呼吸機相關肺炎的治療。
AR-301通過與金葡菌α-毒素的N端抗原表位的特異性結合,防止其形成具有致孔功能的七聚體結構,從而保護肺軟組織不被破壞、免疫細胞不被殺死,維持免疫細胞的殺菌功能。AR-301已獲得美國食品和藥品管理局(FDA)快速審評資格認定和歐洲藥品管理局(EMA)孤兒藥資格認定,目前正處於III期全球多中心臨牀試驗階段。2019年7月,AR-301的III期藥品臨牀試驗申請獲國家藥品監督管理局批准,並與美國、歐洲等國家和地區同步開展III期臨牀試驗。作為全球MRCT的一部分,瑞迪生物在中國啟動AR-301的III期臨牀試驗,2020年第四季度開始招募患者,本次補充申請表明AR-301的臨牀實驗在按計劃推進中。
瑞迪生物為公司與Aridis Pharmaceuticals Inc.設立的合資公司,主要業務為在大中華地區開發Aridis Pharmaceuticals Inc.正處於臨牀試驗階段的多個品種及進行後續的市場推廣。截至本公吿日,公司在瑞迪生物的持股比例為51%。
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