昊海生科(688366.SH)子公司“人工晶狀體”醫療器械啟動臨牀試驗
格隆匯9月28日丨昊海生科(688366.SH)公佈,公司控股子公司河南賽美視生物科技有限公司在研產品“人工晶狀體”在臨牀試驗牽頭單位中山大學中山眼科中心通過倫理會審查,並完成了河南省藥品監督管理局的備案。公司已經完成了該臨牀試驗的準備工作,認為已經具備啟動臨牀試驗的條件,決定啟動臨牀試驗。
本產品為可摺疊、疏水性丙烯酸酯、單焦、非球面人工晶狀體,用於矯正白內障超聲乳化手術中無晶狀體眼的視力。本產品採用創新性一次性模注成型生產工藝,該生產技術預期將顯著降低成本,並製造出性能穩定的高品質人工晶狀體,提高產品合格率,改善手術後視覺質量。本產品將擴充公司疏水人工晶狀體產品線,且本產品所應用的模注工藝平台的使用亦將推進公司後續高端功能性疏水人工晶狀體全系列產品的開發。
根據產品臨牀試驗設計方案,公司預計臨牀試驗週期為2-3年。但醫療器械從臨牀試驗到投產上市的週期長,環節多,易受到諸多不可預測的因素影響,臨牀試驗進度及結果、未來產品市場競爭形勢均存在諸多不確定性。
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