恒瑞醫藥(600276.SH)提交的SHR0302片藥物上市許可申請獲國家藥監局受理
格隆匯12月3日丨恒瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局下發的《受理通知書》,公司提交的SHR0302片藥物上市許可申請獲國家藥監局受理。
2023年9月,SHR0302片Ⅲ期臨牀試驗(SHR0302-301)達到了方案預設的主要研究終點。該研究是一項在傳統合成改善病情抗風濕藥反應不佳的中至重度活動性類風濕性關節炎受試者中評價SHR0302片療效和安全性的多中心、隨機、雙盲、安慰劑對照的Ⅲ期臨牀研究,由中國醫學科學院北京協和醫院曾小峯教授擔任主要研究者,共入組566例成人中重度活動性類風濕關節炎患者。SHR0302片8mg和4mg兩個劑量組在主要終點上均顯著優於安慰劑組,且在中重度活動性類風濕關節炎患者中長期治療的安全性、有效性良好,與其他JAK1抑制劑相比未發現新的安全性信號。
SHR0302片是一種高選擇性的JAK1抑制劑,可通過抑制JAK1信號傳導發揮抗炎和抑制免疫的生物學效應。目前全球範圍內已有針對類風濕關節炎的口服同靶點藥物獲批上市,包括輝瑞的託法替布片(XELJANZ)、艾伯維的烏帕替尼緩釋片(RINVOQ)和禮來的巴瑞替尼片(OLUMIANT)等,但尚未有國內企業自研的JAK1抑制劑獲批上市。經查詢EvaluatePharma數據庫,2022年託法替布片、烏帕替尼緩釋片和巴瑞替尼片全球銷售額合計約為51.49億美元。截至目前,SHR0302片相關項目累計已投入研發費用約72,933萬元。
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