中國生物製藥(01177.HK)：1類創新藥羅伐昔替尼片ROVADICITINIB (TQ05105)關鍵註冊研究取得陽性結果
格隆匯4月18日丨中國生物製藥(01177.HK)公吿，集團自主研發的1類創新藥羅伐昔替尼片Rovadicitinib (TQ05105)用於治療中高危骨髓纖維化(MF)的關鍵註冊臨牀研究已達到主要終點。集團已與中國國家藥品監督管理局藥品審評中心(CDE)就TQ05105片的上市申請進行了溝通，並獲得CDE同意提交本品上市申請的意見。集團將於近期遞交TQ05105片的上市申請。
TQ05105是集團自主研發的一款具有全新化學結構的JAK/ROCK抑制劑。體外試驗結果顯示，TQ05105能夠有效抑制JAK家族激酶活性及ROCK激酶活性，能顯著抑制細胞中STAT3和STAT5的磷酸化水平，從而抑制JAK/STAT信號通路傳導作用，進而發揮抗腫瘤活性。
集團於2023年美國血液學年會(ASH)公佈了TQ05105用於治療骨髓增殖性腫瘤(MPN)的I期臨牀研究數據。結果表明，TQ05105具有良好的人體藥代動力學行為，安全性良好，毒性可耐受，且脾臟縮小療效(最佳縮脾率63.79%)和改善患者體質症狀(最佳改善率為87.50%)作用顯著，作用時間持久，能夠為MF患者帶來更多的臨牀選擇。
此外，集團於2023年歐洲血液學年會(EHA)公佈了TQ05105在慢性移植物抗宿主病(cGVHD)中的Ib/II期臨牀研究數據。結果表明，TQ05105具有良好的安全性，且對各排異器官部位緩解率高(最佳客觀緩解率86.7%)，顯著改善臨牀症狀(40%患者LSS評分改善≥7分)，73.3%患者降低激素使用劑量，有望為cGVHD患者帶來更好的臨牀治療選擇。
MF是一種瀰漫性骨髓纖維組織增生性疾病，屬於MPN的一種，最終會進展為骨髓衰竭或轉化為急性白血病。2023年9月，原發性骨髓纖維化(PMF)被納入中國《第二批罕見病目錄》。目前，國內僅有一款產品獲批用於MF患者的治療，臨牀存在較大未被滿足的需求。
集團在骨髓纖維化領域還佈局了多項聯合研究，如TQ05105聯合BET抑制劑或BCL-2抑制劑，用於治療中高危骨髓纖維化的臨牀研究，初步結果較為積極。TQ05105是集團即將申報上市的又一款1類創新藥。隨着集團在創新藥研發中的不斷投入，創新產品取得不斷突破，創新管線已進入收穫期。
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