荃信生物-B(02509.HK)：QX005N結節性癢疹III期臨牀試驗順利完成受試者入組
格隆匯3月20日丨荃信生物-B(02509.HK)公告，於2025年3月19日，公司自主研發的QX005N注射液PNIII期臨牀試驗(登記號：CTR20241660)完成共409例受試者入組，這是國內首個由中國企業開展的針對PN適應症的III期臨牀試驗，也是目前全球範圍內最大人羣規模的PN關鍵性臨牀試驗。2024年1月31日，QX005N被國家藥品監督管理局藥品審評中心納入突破性治療品種名單，對應適應症即爲PN。
本試驗是一項評價QX005N在治療PN成人受試者中的有效性和安全性的多中心、隨機、雙盲、安慰劑對照的III期臨牀研究，其主要研究目的是評估QX005N在PN受試者中對瘙癢緩解的有效性。在此前針對PN的II期臨牀研究中，QX005N各組(300mg組、450mg組、600mg組)第16周最嚴重瘙癢數字評定量表(WI-NRS)有效受試者比例均明顯高於安慰劑組，差異具有統計學意義，且整體安全性、耐受性良好。
PN是一種慢性瘙癢性、炎症性皮膚疾病，其臨牀表現爲高度角化、對稱分佈於四肢伸側的瘙癢性丘疹和結節。瘙癢引起搔抓使本疾病變得愈加嚴重。長期頑固性瘙癢給患者心理帶來嚴重的影響，並極大降低患者的生活品質。目前該病病因不明，皮膚疾病、系統性疾病、神經或精神╱心理因素等均可誘發PN發生。根據弗若斯特沙利文的資料，2022年中國PN患者數量約爲200萬人。該疾病存在迫切且巨大的未滿足臨牀需求。
QX005N是一款以人IL-4受體α亞基(IL-4Rα)爲靶點的創新型人源化單克隆抗體，其通過與IL-4Rα特異性結合，阻斷IL-4Rα與IL-4以及IL-13的結合，同時抑制IL-4和IL-13介導的信號通路與生物學效應，從而對2型炎症過敏性疾病發揮治療作用。QX005N注射液已獲得用於治療成人中重度特應性皮炎、12-17歲青少年特應性皮炎、PN、慢性鼻竇炎伴有鼻息肉、慢性自發性蕁麻疹、哮喘及慢性阻塞性肺疾病等適應症的7項IND許可。
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