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康辰藥業(603590.SH):地拉羅司分散片獲得報產受理通知
格隆匯 08-04 15:35

格隆匯8月4日丨康辰藥業(603590.SH)公佈,近日,公司收到國家藥品監督管理局關於地拉羅司分散片的《受理通知書》。

藥物名稱:地拉羅司分散片;規格:125mg/片;受理號:CYHS2000539國;註冊分類:化學藥品4類;申請事項:境內生產藥品註冊;申請人:北京康辰藥業股份有限公司;審批結論:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。

地拉羅司分散片為公司自主研發的化學仿製藥,是國家衞健委2019年公佈的《第一批鼓勵仿製藥品目錄建議清單》品種之一。公司於2016年7月取得地拉羅司分散片的藥物臨牀試驗批件,並根據相關法規要求開展臨牀生物等效性試驗,研究結果為生物等效;2020年8月收到國家藥監局的受理通知。

地拉羅司是口服鐵離子螯合劑,有效地提高鐵的排泄,降低體內鐵的含量及其在各器官的病理性沉積;用於治療年齡大於2歲的β-地中海貧血和其它輸血依賴性疾病所致的鐵過載,也用於治療10歲及10歲以上非輸血依賴性地中海貧血綜合徵患者的慢性鐵過載。

截至公告日,公司在地拉羅司分散片上投入的研發費用約1,958.76萬元人民幣。

根據國家藥品註冊相關法律法規要求,地拉羅司分散片在獲國家藥監局註冊申請受理後將轉入國家藥監局藥品審評中心接受技術審評、現場核查、抽樣檢驗等一系列環節,經審批通過後方可生產上市,完成審批的時間和結果均具有一定的不確定性。因此,上述產品獲得註冊受理對公司近期業績不會產生影響。

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