share_log

中國生物製藥：自願公告 - MASH產品「拉尼蘭諾」、「TQA2225」開發進展更新

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - UPDATE ON DEVELOPMENT PROGRESS OF MASH PRODUCTS "LANIFIBRANOR" AND "TQA2225"

香港交易所 ·  Mar 15 05:56
Summary by Moomoo AI
中國生物製藥有限公司宣佈，旗下兩款藥物「拉尼蘭諾」及「TQA2225」在中國進行的臨床試驗取得進展。拉尼蘭諾，一種口服小分子藥物，已在國際III期臨床試驗中恢復入組，並預計於2024年完成所有受試者入組。此藥物已獲FDA突破性療法認證和快速通道資格，並於2023年3月向CDE遞交臨床試驗申請。TQA2225，一款全人源長效FGF21融合蛋白，目前正在中國進行II期臨床試驗，有望成為中國首個上市的FGF21融合蛋白。中國生物製藥致力於加速推動這兩款藥物的臨床研發，以填補中國MASH市場的空白。
中國生物製藥有限公司宣佈，旗下兩款藥物「拉尼蘭諾」及「TQA2225」在中國進行的臨床試驗取得進展。拉尼蘭諾，一種口服小分子藥物，已在國際III期臨床試驗中恢復入組，並預計於2024年完成所有受試者入組。此藥物已獲FDA突破性療法認證和快速通道資格，並於2023年3月向CDE遞交臨床試驗申請。TQA2225，一款全人源長效FGF21融合蛋白，目前正在中國進行II期臨床試驗，有望成為中國首個上市的FGF21融合蛋白。中國生物製藥致力於加速推動這兩款藥物的臨床研發，以填補中國MASH市場的空白。
China Biopharmaceuticals Limited announced the progress of its clinical trials of two drugs Lanilrano and TQA2225 in China. LANILANO, AN ORAL SMALL MOLECULE DRUG, HAS BEEN RESUMED IN AN INTERNATIONAL PHASE III CLINICAL TRIAL AND IS EXPECTED TO COMPLETE ENROLLMENT OF ALL SUBJECTS BY 2024. The drug has received FDA breakthrough therapy approval and fast-track eligibility and submitted a clinical trial application to the CDE in March 2023. TQA2225, AN ALL-HUMAN LONG-ACTING FGF21 FGF21 FUSION PROTEIN, IS CURRENTLY UNDERGOING PHASE II CLINICAL TRIALS IN CHINA AND IS EXPECTED TO BECOME THE FIRST PUBLICLY TRADED FGF21 FGF21 FUSION PROTEIN IN CHINA. China Biopharmaceuticals is working to accelerate the clinical development of these two drugs to fill the void in the MASH market in China.
China Biopharmaceuticals Limited announced the progress of its clinical trials of two drugs Lanilrano and TQA2225 in China. LANILANO, AN ORAL SMALL MOLECULE DRUG, HAS BEEN RESUMED IN AN INTERNATIONAL PHASE III CLINICAL TRIAL AND IS EXPECTED TO COMPLETE ENROLLMENT OF ALL SUBJECTS BY 2024. The drug has received FDA breakthrough therapy approval and fast-track eligibility and submitted a clinical trial application to the CDE in March 2023. TQA2225, AN ALL-HUMAN LONG-ACTING FGF21 FGF21 FUSION PROTEIN, IS CURRENTLY UNDERGOING PHASE II CLINICAL TRIALS IN CHINA AND IS EXPECTED TO BECOME THE FIRST PUBLICLY TRADED FGF21 FGF21 FUSION PROTEIN IN CHINA. China Biopharmaceuticals is working to accelerate the clinical development of these two drugs to fill the void in the MASH market in China.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more