珍寶島(603567.SH):抗特發性肺纖維化1類創新藥物ZBD0276片獲批臨牀試驗
格隆匯 8 月 12日丨珍寶島(603567.SH)公佈,公司於2020年6月2日披露了公司收到國家藥品監督管理局(“國家藥監局”)下發的抗特發性肺纖維化1類創新藥物ZBD0276片臨牀試驗申請《受理通知書》的公告。近日,公司獲得國家藥監局下發的《藥物臨牀試驗批准通知書》。
該產品是公司與上海藥明康德新藥開發有限公司依據雙方簽署的“1類新藥項目技術開發合同”,而共同進行研究開發的抗特發性肺纖維化(IPF)1類創新藥物,由公司擁有自主知識產權。
IPF是一種慢性、進行性、纖維化性間質性肺疾病,病變侷限在肺臟,好發於中老年人羣,其肺組織學和/或胸部高分辨率CT(HRCT)特徵性表現為普通型間質性肺炎(UIP),病因不清。據統計,每年整體人羣中的患病率約(2~29)/10萬,且呈逐漸增長趨勢,估計以每年11%的比例增長。作為一種慢性間質性肺病,IPF起病隱匿、病情逐漸加重,也可表現為急性加重。IPF診斷後的平均生存期僅2.8年,死亡率高於大多數腫瘤,IPF被稱為一種“類腫瘤疾病”。
IPF發病機制複雜,目前尚未完全闡明,但有證據表明其與免疫炎症損傷有關。臨牀前研究顯示,ZBD0276可通過抑制炎症及纖維化通路Th1/Th2和轉化生長因子TGF-β,抑制炎症及纖維化的產生,從而改善肺部炎症和纖維化。動物模型評估ZBD0276體內藥效優於同類已上市對照藥,具有較好的安全性、成藥性和臨牀開發價值。
根據國家藥品註冊相關的法律法規規定,上述藥物已獲得臨牀試驗批准,公司還需開展臨牀試驗並經國家藥監局審評,審批通過後方可生產上市。
該項目截至目前累計研發投入約2800萬元,後續公司將進一步加大產品研發投入。
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