恆瑞醫藥(600276.SH)：RSJ10101研究達到主要及關鍵次要研究終點
格隆匯 2 月 4日丨恆瑞醫藥(600276.SH)公佈，近日，公司子公司瑞石生物醫藥有限公司(“瑞石生物”)治療潰瘍性結腸炎的隨機、雙盲、安慰劑對照、多中心的全球II期臨牀研究RSJ10101 (AMBER2)(“RSJ10101研究”)，達到主要及關鍵次要研究終點。研究結果顯示，在治療第8周，接受口服SHR0302片8mg一天一次或4mg一天兩次或4mg一天一次的成人潰瘍性結腸炎患者臨牀應答的比例顯著高於安慰劑組。SHR0302治療組與安慰劑組相比，實現了有顯著統計學意義的臨牀應答。
RSJ10101研究是一項評估口服SHR0302對比安慰劑用於中度至重度潰瘍性結腸炎成人人羣治療的有效性和安全性的隨機、雙盲、安慰劑對照、多中心的全球II期臨牀研究。研究的主要終點是治療期第8周時達到臨牀應答的受試者百分比，臨牀應答定義為：根據改良的9分制Mayo評分相比基線至少降低2分以及至少降低30%，同時便血子項評分至少降低1分或便血子項絕對評分為0或1分。
本研究共入組164例成人中重度活動性潰瘍性結腸炎受試者，符合條件的患者被隨機分配三組口服日劑量的SHR0302（8mg每天一次或4mg每天兩次或4mg每天一次）或安慰劑，共治療8周。主要終點為第8周的臨牀應答率。研究結果顯示，接受8mg日劑量SHR0302片和4mg日劑量SHR0302片的患者達到臨牀應答的比例顯著高於安慰劑組，在實現臨牀緩解及粘膜癒合方面SHR0302的療效同樣顯著優於安慰劑。
根據我國藥品註冊相關的法律法規要求，瑞石生物將就上述研究結果及後續臨牀開發計劃與藥監部門進行溝通交流，並儘快啟動本品用於中度至重度潰瘍性結腸炎的III期臨牀研究。公司將按國家有關規定及時對項目後續進展情況履行信息披露義務。
SHR0302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。在海外，SHR0302片在美國、波蘭、烏克蘭和澳大利亞開展國際多中心II期臨牀試驗，並在加拿大獲準III期臨牀試驗。
經查詢，國外目前有同類產品託法替尼於美國獲批上市銷售，適應症為類風濕性關節炎和潰瘍性結腸炎。託法替尼於2017年3月在國內獲批上市銷售，適應症為類風濕性關節炎，但未獲批用於治療潰瘍性結腸炎。經查詢EvaluatePharma數據庫，託法替尼2019年全球銷售額約為22.42億美元。
截至目前，SHR0302相關項目累計已投入研發費用約23710萬元。
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