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重慶文理學院自主研發一類新藥獲批進入中美臨床

發布時間:2019-06-04 作者:胡航宇 來源:?中國教育新聞網

中國教育新聞網訊(記者 胡航宇)近日,重慶文理學院和重慶迪康爾樂制藥有限公司簽訂成果轉化協議,雙方將共同推進重慶文理學院自主研發的PDE5(磷酸二酯酶)抑制劑一類新藥在美國和中國的臨床I期試驗。

據了解,PDE5抑制劑一類新藥由重慶文理學院創新靶向藥物國際研究院歷時5年研發而成。去年,這個具有完全自主知識產權的一類新藥,同時獲得國家藥品監督管理局(CFDA)和美國FDA臨床批文,在中國和美國即將開展臨床試驗研究。   

據介紹,該抑制劑可以高效選擇性抑制PDE5激酶,在臨床上可以用于治療男性性功能障礙(ED),肺動脈高壓和前列腺肥大等疾病。該藥物與現上市藥物相比具有安全性更高、起效時間更短、劑量更小、半衰期適中等特點,具有廣闊的市場前景。

今年5月,重慶市政府出臺《關于印發重慶市加快生物醫藥產業發展若干政策的通知》,PDE5抑制劑一類新藥是由重慶自主研發、重慶本土進行轉化的第一個新藥,也是學院認真落實習近平總書記對重慶提出發揮“三個作用”要求,轉化為任務清單和實際行動的具體舉措。

重慶文理學院創新靶向藥物國際研究院院長陳中祝介紹,當前,還有一個與美國合作研發的抗癌新藥正在進行臨床前安全評價,預計今年年底可以申請中美臨床批文后進入中美臨床。此抗癌新藥是全球首個同時針對RET和 VEGFR2開發的全新結構的抑制劑,具有高活性(體外活性達到1nM以下,體內活性0.3mg/Kg)和高度選擇性,可用于治療甲狀腺癌、乳腺癌、肺癌等惡性腫瘤。未來2-3年內,該團隊會繼續將治療急性白血病、骨質疏松等靶向新藥推向臨床。

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