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冠昊生物(300238.SZ)控股子公司承擔國家科技重大專項任務
格隆匯 12-19 17:49

格隆匯12月19日丨冠昊生物(300238.SZ)公佈,公司的控股子公司北京文豐天濟醫藥科技有限公司於近日與國家衞生健康委醫藥衞生科技發展研究中心簽署《國家科技重大專項(民口)課題任務合同書》,承擔“十三五”“重大新藥創制”國家科技重大專項任務,課題名稱為1類化學新藥苯烯莫德乳膏治療兒童濕疹的臨牀研究。

濕疹是一種劇烈瘙癢性、慢性、複發性炎性皮膚病,遺傳和環境因素、皮膚屏障功能缺陷和免疫功能異常是濕疹發病的主要因素。據估計,我國約有3,000萬兒童和4,200多萬成人患者,由於發病率高,對患者生活質量影響大,已經成為國際上一個重大的公共衞生問題。目前濕疹常用的外用治療主要為糖皮質激素和免疫抑制劑,激素類藥物副作用多,且不宜長期使用,不能滿足長期用藥特別是兒童濕疹患者治療的需要。因此,開發一種有效、副作用小的治療兒童濕疹的藥物十分迫切。

本維莫德(曾用名:苯烯莫德)是全球首創新一代治療炎症性和自身免疫性疾病的非激素類新型小分子化學藥,是首個治療性芳香烴受體調節劑,在同一領域具有國際領先水平。2019年5月,國家1類新藥本維莫德乳膏被國家藥品監督管理局獲批上市,用於治療輕中度銀屑病,是全球首創新藥(First-in-class)。

在我國,本維莫德在濕疹中的臨牀療效已經確證。2017 年6 月國家食品藥品監督管理局批准本維莫德乳膏治療濕疹的臨牀研究(臨牀批件:2017L02086),目前正在開展本維莫德乳膏治療濕疹有效性和安全性的隨機、雙盲、安慰劑、陽性藥對照的II-III期多中心臨牀研究。

此次課題研究的目的是擴大本維莫德乳膏的適應症,開展用於治療濕疹的全部臨牀研究,加快國家1 類新藥本維莫德乳膏新適應症濕疹的研發和產業化進程,儘早滿足濕疹患者用藥特別是兒童濕疹有效治療的需求。

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