盈康生命(300143.SZ)：子公司醫療器械註冊證到期尚未完成延續註冊
格隆匯 9 月 4日丨盈康生命(300143.SZ)公佈，公司全資子公司瑪西普醫學科技發展(深圳)有限公司(“瑪西普”)持有的中華人民共和國醫療器械註冊證(註冊證編號：國械注準20153331588)將於2020年9月5日到期。
產品名稱：立體定向伽瑪射線體部治療系統；註冊證編號：國械注準20153331588；註冊分類：第三類；適用範圍：該產品適用於胸腹部實體腫瘤的放射治療(體部腫瘤Φ≤5cm)，具體適應症有：原發性肺癌和肺轉移癌、原發性肝癌和肝轉移癌、縱膈腫瘤、胰腺癌、腹腔內腫瘤、肝血管瘤、宮頸癌。
瑪西普已於2020年7月28日向國家藥品監督管理局提交了上述“立體定向伽瑪射線體部治療系統”(“體部伽瑪刀”)醫療器械註冊證的延續註冊申請，並取得了國家藥品監督管理局出具的《受理通知書》。受2020年新型冠狀病毒肺炎疫情影響，延續註冊審批時間有所延長。截至公告披露日，該產品尚未取得延續註冊核准。
瑪西普體部伽瑪刀的醫療器械註冊證到期後，瑪西普在2020年9月6日前生產的體部伽瑪刀仍可繼續銷售。自2020年9月6日起至體部伽瑪刀醫療器械註冊證延續註冊核准通過前，瑪西普將暫停體部伽瑪刀的生產。從公司2019年醫療器械產品的銷售情況看，公司對外銷售體部伽瑪刀(不含內部銷售)的收入僅佔公司醫療器械板塊收入的3.69%，體部伽瑪刀的銷售對公司影響較小。此外，為應對體部伽瑪刀註冊證是否能通過延續註冊的風險，瑪西普正在研發新型的伽瑪刀和直線加速器產品，其功能可以覆蓋體部伽瑪刀的治療適用範圍，目前兩款產品均處於機房調試階段。公司聚焦醫療器械高端發展戰略，致力於打造全球領先的腫瘤治療科技生態品牌，若未來前述兩款產品均研發成功並通過註冊，將進一步豐富和補充公司的產品線，提高公司的持續競爭力，對公司未來經營產生積極影響。
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