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信達生物：自願公告 - IBI311治療甲狀腺眼病的III期臨床研究達成主要終點

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE PHASE 3 CLINICAL STUDY OF IBI311 MET THE PRIMARY ENDPOINT IN TREATING THYROID EYE DISEASE

香港交易所 ·  Feb 19 18:30
Summary by Moomoo AI
信達生物製藥有限公司（「信達生物」）於2024年2月20日宣佈，旗下研發的IBI311治療甲狀腺眼病（TED）的III期臨床研究在中國達成主要終點。該研究名為RESTORE-1，是一項多中心、隨機、雙盲安慰劑對照的II/III期臨床研究，結果顯示IBI311治療組的眼球突出應答率顯著優於安慰劑組。信達生物計劃向國家藥品監督管理局遞交新藥上市申請。TED是一種與甲狀腺疾病相關的自身免疫性疾病，目前國內尚無針對此病的靶向藥物獲批。IBI311作為靶向IGF-1R的單克隆抗體，在研究中展示出良好的療效和安全性，有望改善中國TED患者的治療現狀。
信達生物製藥有限公司（「信達生物」）於2024年2月20日宣佈，旗下研發的IBI311治療甲狀腺眼病（TED）的III期臨床研究在中國達成主要終點。該研究名為RESTORE-1，是一項多中心、隨機、雙盲安慰劑對照的II/III期臨床研究，結果顯示IBI311治療組的眼球突出應答率顯著優於安慰劑組。信達生物計劃向國家藥品監督管理局遞交新藥上市申請。TED是一種與甲狀腺疾病相關的自身免疫性疾病，目前國內尚無針對此病的靶向藥物獲批。IBI311作為靶向IGF-1R的單克隆抗體，在研究中展示出良好的療效和安全性，有望改善中國TED患者的治療現狀。
SINDA BIOPHARMACEUTICAL CO., LTD. (“SINDA BIOLOGIC”) ANNOUNCED ON FEBRUARY 20, 2024 THAT THE PHASE III CLINICAL TRIAL OF ITS FLAGSHIP IBI311 TREATMENT FOR THYROID EYE DISEASE (TED) HAS REACHED MAJOR TERMINATION IN CHINA. The study, called RESTORE-1, was a multicenter, randomized, double-blind placebo comparison, and the results showed that the IBI311 treatment group had a significantly better eye response rate than the placebo group. Sinda Biologics Program submits a new drug listing application to the National Drug Administration. TED is an autoimmune disease associated with thyroid disease and currently no targeted drug for this disease has been approved in the country. IBI311, as a monoclonal antibody targeting IGF-1R, demonstrated good efficacy and safety in the study and is expected to improve the treatment status of TED patients in China.
SINDA BIOPHARMACEUTICAL CO., LTD. (“SINDA BIOLOGIC”) ANNOUNCED ON FEBRUARY 20, 2024 THAT THE PHASE III CLINICAL TRIAL OF ITS FLAGSHIP IBI311 TREATMENT FOR THYROID EYE DISEASE (TED) HAS REACHED MAJOR TERMINATION IN CHINA. The study, called RESTORE-1, was a multicenter, randomized, double-blind placebo comparison, and the results showed that the IBI311 treatment group had a significantly better eye response rate than the placebo group. Sinda Biologics Program submits a new drug listing application to the National Drug Administration. TED is an autoimmune disease associated with thyroid disease and currently no targeted drug for this disease has been approved in the country. IBI311, as a monoclonal antibody targeting IGF-1R, demonstrated good efficacy and safety in the study and is expected to improve the treatment status of TED patients in China.
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