信達生物(01801.HK)：中國首個IGF-1R單抗信必敏®獲國家藥品監督管理局批准上市用於治療甲狀腺眼病
信達生物(01801.HK)公吿，重組抗胰島素樣生長因子1受體("IGF-1R")抗體信必敏®(替妥尤單抗N01注射液)的新藥上市申請("NDA")獲中國國家藥品監督管理局("NMPA")批准上市，用於治療甲狀腺眼病(Thyroid Eye Disease,TED)。信必敏®是中國首個、全球第二款獲批的IGF-1R抗體藥物，也是中國甲狀腺眼病治療領域70年來的首款新藥，將重塑甲狀腺眼病的治療標準。
甲狀腺眼病是與甲狀腺疾病密切相關的一種器官特異自身免疫性疾病，位居成人眼眶疾病發病率首位，在40-60歲年齡段尤其高發。甲狀腺眼病的年發病率預估為16/100,000人(女性)和2.9/100,000人(男性)，患病率為0.1-0.3%。令人擔憂的是，近年來該疾病呈現明顯的年輕化趨勢。甲狀腺眼病引起眼球突出、複視等臨牀表現，嚴重的可導致失明，對患者視力和生活質量造成嚴重影響。
目前，我國中重度活動性甲狀腺眼病的傳統一線治療方案為糖皮質激素靜脈衝擊(IVGC)治療，突眼改善不理想，且存在激素相關的全身副作用等問題；二線治療包括再次激素衝擊或聯合眼眶放療或其他免疫調節劑，治療效果難如人意。近期國內外多項臨牀治療指南和專家共識已將靶向IGF-1R的生物製劑列入甲狀腺眼病推薦治療方案中的二線推薦，尤其對於合併顯著突眼或複視的甲狀腺眼病，靶向IGF-1R的生物製劑可作為首選。
直到信必敏®獲批之前，全球僅有一款IGF-1R抗體藥物獲批且未在國內上市。信必敏®作為中國首個獲批的IGF-1R抗體，療效優異，安全性良好，為甲狀腺眼病患者帶來了全新可及的治療選擇，具有重要的臨牀及社會價值。同時，信必敏®採用劑型改良的注射液水針，穩定性良好，成本、工藝簡便性和依從性方面也具有優勢。
本次獲批基於一項在甲狀腺眼病患者中開展的III期註冊臨牀研究(RESTORE-1)的研究結果。該研究於2024年順利達成主要研究終點，研究顯示：採用信必敏治療24周時，患者突眼回退≥2mm的應答率高達85.8%，炎症和生活質量也顯著改善。研究治療期間，信必敏®整體安全性良好。RESTORE-1研究結果在包括世界眼科學大會(WOC)、中華醫學會內分泌學學術會議(CSE)、全國眼科學術大會(CCOS)等多個重磅學術大會亮相，行業專家學者高度關注與期待這一突破性療法的上市。
此次信必敏®獲批是公司在重大疾病治療領域取得的又一里程碑突破，將為國內患者提供具有國際水準的精準治療方案，切實解決這一長期未被滿足的臨牀需求。面向未來，公司將持續深耕腫瘤、自身免疫、代謝及心血管、眼科四大治療領域，踐行"開發出老百姓用得起的高質量生物藥"的企業使命。
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