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康辰藥業(603590.SH):終止注射用鹽酸洛拉曲克臨牀試驗
格隆匯 04-21 21:44

格隆匯4月21日丨康辰藥業(603590.SH)公佈,公司在研新藥“注射用鹽酸洛拉曲克”(“迪奧”),處於補充III期臨牀試驗階段。近日,公司審慎權衡“迪奧”項目繼續開發的風險性和未來的臨牀價值,為合理配置公司研發資源,聚焦研發管線中的優勢項目,決定終止該項目的臨牀試驗及後續研發。

“迪奧”是根據胸苷酸合成酶活性中心的三維結構特徵,採用計算機模擬藥物分子技術設計和合成的新型小分子胸苷酸合成酶抑制劑,屬於細胞毒類創新藥。

近年來,隨着我國新藥審批和管理與國際標準的快速接軌,以及小分子替尼類藥物和大分子生物類藥物研發的高速發展,“迪奧”做為細胞毒類產品,在腫瘤臨牀應用上,未來將難以在與眾多靶向抗腫瘤藥物的競爭中獲得優勢後續投入上市風險高。公司審慎評估權衡迪奧項目繼續開發風險性和未來的臨牀價值為合理配置公司研發資源,聚焦研發管線中的優勢項目,決定終止該項目的臨牀試驗及後續研發

“迪奧”20024月獲國家藥品監督管理局(原國家食品藥品監督管理總局,以下簡稱“國家藥監局”)批准開展I期臨牀試驗20044國家藥監局批准開展IIIII期臨牀試驗。公司於20148月向國家藥監局申報“迪奧”新藥證書和生產批件20164月收到國家藥監局的《審批意見通知件》,要求公司補充相關臨牀研究。

截至2020331,“迪奧”累計研發投入6407.01萬元,均為公司自有資按照相關會計準則和公司會計政策,上述研發投入已計入相應會計期間損益。

終止“迪奧”的臨牀試驗及後續研發事項不會對公司當期及未來的生產經營與業績產生重大影響。原募投項目“鹽酸洛拉曲克原料藥產能建設項目已投入建成的廠房及在建工程,將繼續用於公司其他在研品種原料藥生產

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