佰仁醫療(688198.SH):預期《草案》的實施將對公司創新產品的註冊審評產生積極影響
格隆匯9月12日丨佰仁醫療(688198.SH)在互動平台表示,我國《醫療器械管理法(草案徵求意見稿)》(以下簡稱“《草案》”)是黨中央、國務院鼓勵和支持醫療器械產業創新發展的最新決策部署在法律層面的固化,首次將對醫療器械的支持和管理提升到立法高度。 《草案》提出對臨牀急需且國內尚無同類產品獲准註冊或使用數量較少的醫療器械,及列入國家科技攻關、重點行動計劃的醫療器械將實施優先審評審批。 目前,佰仁醫療Renato 經導管瓣膜系統 (介入瓣中瓣)作為創新通道產品正在註冊審評中,該產品適用於前次植介入人工生物瓣膜衰敗後需要再次治療且外科手術高風險或禁忌的患者,其產品設計與驗證、動物試驗設計與臨牀試驗及註冊均為業內首創,具有臨牀急需性。此外,後續如眼科生物補片等多項創新產品將陸續提交註冊申請。預期《草案》的實施將對公司創新產品的註冊審評產生積極影響。
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