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石藥集團(01093.HK):高濃度鹽酸羥鈷胺注射液在中國獲臨牀試驗批準用於治療甲基丙二酸血癥(MMA)

格隆匯7月3日丨石藥集團(01093.HK)公告,集團開發的高濃度鹽酸羥鈷胺注射液("該產品")已獲中華人民共和國國家藥品監督管理局批準,可在中國開展臨牀試驗,用於治療罕見病甲基丙二酸血癥("MMA")。

MMA是一種常染色體隱性遺傳有機酸代謝疾病,最早可在新生兒期發病,並已在中國被收錄於國家衛生健康委員會等5部門聯合制定的《第一批罕見病目錄》中。羥鈷胺注射劑是治療維生素B12反應型MMA的首選推薦藥物,需終身使用。目前,國內外尚無針對MMA適應症的羥鈷胺注射劑獲批上市,對於MMA患者而言,仍存在迫切的未被滿足的醫療需求。

本次獲批的臨牀適應症爲兒童伴有同型半胱氨酸升高的MMA(cblC型)。該產品成爲國內首款獲批開展MMA臨牀試驗的羥鈷胺注射劑,其開發有望爲MMA患者提供新的治療選擇,具有較高的臨牀開發價值。

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