華大基因(300676.SZ)：地中海貧血基因檢測產品獲得SFDA批准上市
格隆匯10月10日丨華大基因(300676.SZ)公佈，公司全資子公司BGI Europe A/S(以下簡稱歐洲醫學)的地中海貧血基因檢測試劑盒(聯合探針錨定聚合測序法)於近日獲得Saudi Food & Drug Authority (英文簡稱SFDA，中文譯名沙特阿拉伯食品藥品管理局)批准上市。
地中海貧血是一種因珠蛋白合成障礙導致的遺傳性溶血性疾病，是全球分佈廣泛、累及人羣較多且危害嚴重的一種單基因遺傳病。根據2008年世界衞生組織發佈的全球血紅蛋白病流行病學報吿統計，每年有超過332,000例地中海貧血患兒出生，約56000例為重度地中海貧血患兒，其中至少30000例患兒需要定期輸血才能存活。重型地中海貧血患兒的出生給家庭及社會帶來嚴重影響，血紅蛋白病是全世界範圍內的一大公共衞生問題。
地中海貧血難治但可防，通過婚前、孕前和產前階段對育齡人羣進行地中海貧血篩查、診斷和干預，可以有效降低中、重型地中海貧血患兒出生。公司是高通量測序技術檢測地中海貧血的引領者，所開發的地中海貧血基因檢測新技術具有準確率高、檢測全面、高通量和低成本等優勢，將為全球的地中海貧血和其他血紅蛋白病(如鐮狀細胞性貧血)的防控提供了一種新的技術方案。相比血常規、血紅蛋白電泳、高效液相色譜法和常規基因檢測等方法，可實現血紅蛋白病的基因攜帶者篩查，有助於在全球範圍內更好地防控血紅蛋白病。
歐洲醫學的地中海貧血基因檢測試劑盒(聯合探針錨定聚合測序法)符合沙特阿拉伯醫療器械臨時條例(Medical devices interim regulation, MDIR)及醫療器械銷售授權(Medical Device Marketing Authorisation, MDMA)實施規則的規定及要求，獲得SFDA 批准上市，具備了在沙特阿拉伯進行銷售的准入資質。
上述產品獲得SFDA 批准上市，進一步擴大了公司在沙特等中東地區的影響力和業務範圍，以期助力區域遺傳性疾病相關的防控工作，為長期本地化發展與合作奠定基礎。此外，本次註冊獲批是公司深入拓展國際佈局，實現海外業務可持續發展的又一重要成果，有利於加速提升公司全球市場份額，進一步加強公司產品的國際競爭力。上述產品實際銷售情況取決於未來市場推廣效果，公司目前尚無法預測其對公司未來業績的影響，敬請投資者注意投資風險。
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