科倫藥業(002422.SZ):“注射用紫杉醇(白蛋白結合型)”獲得藥品註冊證書
格隆匯 8 月 18日丨科倫藥業(002422.SZ)公佈,子公司湖南科倫製藥有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“注射用紫杉醇(白蛋白結合型)”的《藥品註冊證書》,現將相關情況公告如下:
藥品名稱:注射用紫杉醇(白蛋白結合型)
劑型:注射劑
規格:100mg
申請事項:化學藥品(境內生產)
註冊分類:化學藥品4類
受理號:CYHS1800537
藥品批准文號:國藥準字H20203443
申請人:湖南科倫製藥有限公司
審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。
注射用紫杉醇(白蛋白結合型)為公司首個獲批上市的抗腫瘤藥物納米制劑,且公司在製備紫杉醇白蛋白納米粒時採用了新工藝,革除了原研產品中使用的二類有害溶媒,生產過程更加綠色環保,患者使用更安全,且規模化生產更具優勢。目 前該技術平台已佈局系列發明專利,其中包括一項PCT專利申請(WO2018059304A1)和一項美國專利申請(US16321591)。此外,注射用紫杉醇(白蛋白結合型)也為公司繼吉非替尼片、唑來膦酸注射液(4mg/100ml)後第三個獲批上市的抗腫瘤藥物,將進一步豐富公司的抗腫瘤產品線。
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