甘李藥業(603087.SH)：子公司“注射筆用針頭”獲得美國FDA醫療器械註冊批准
格隆匯 8 月 28日丨甘李藥業(603087.SH)公告，近日，公司全資子公司甘甘醫療科技江蘇有限公司(以下簡稱“甘甘醫療”)獲得美國食品藥品監督管理局(以下簡稱“FDA”)同意甘甘醫療產品注射筆用針頭的註冊申請的回函。
1、器械名稱：注射筆用針頭(InjectionPenNeedle)
企業名稱：甘甘醫療科技江蘇有限公司
510k碼：K192464
2、產品的其他相關情況
我國的糖尿病患者呈逐年上升的趨勢，糖尿病患者需要進行嚴格的血糖控制，注射胰島素是有效且不良反應較小的治療方法，患者常使用筆式注射器和注射筆用針頭進行胰島素注射。本次獲批的注射筆用針頭(InjectionPenNeedle)為甘甘醫療自主研發產品，擬用於配合筆式注射器進行藥物的皮下注射。根據行業市場調研，2019年，注射筆用針頭同類產品優鋭針(BD公司)、諾和針(諾和諾德公司)國內市場銷售額分別約3.5億、2億元人民幣，本土品牌KDL針頭(浙江康德萊醫療器械有限公司)、宜鋭針(蘇州施萊醫療器械有限公司)等國內市場銷售額與進口廠商相比，銷售額較少。
截至目前，公司該項目總投入為3,497萬元人民幣。該產品於2019年9月獲得國家藥品監督管理局批准的醫療器械註冊證，同期，甘甘醫療也向美國FDA提交了醫療器械上市前通知(510k)申請。經FDA審查，確認了產品的實質等效性，獲得根據一般控制規定銷售該器械的批准，後續向FDA申請公司營業地點註冊和產品列示獲批後，可將該產品售往美國市場。
甘甘醫療的注射筆用針頭雖然獲得了FDA根據一般控制規定銷售該器械的批准，但受到境外市場需求變化、政策環境變化、匯率波動、市場競爭等因素的影響，相關產品在境外市場的拓展進度、銷售規模存在一定的不確定性。目前子公司僅在國內銷售醫療器械，沒有在美國銷售醫療器械產品的經驗。
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