康哲藥業(00867.HK)創新藥甲氨蝶呤注射液(預充式)用於治療RA的中國III期橋接試驗完成首例受試者給藥

4月12日,康哲藥業控股有限公司(00867.HK)創新藥甲氨蝶呤注射液(預充式)用於治療成人類風濕關節炎(RA)的中國III期橋接試驗完成首例受試者給藥。這是繼該產品2021年8月RA適應症中國IND獲批後的又一重大進展。
該研究為隨機、開放、陽性對照、多中心的III期橋接試驗,旨在比較甲氨蝶呤注射液(預充式)和甲氨蝶呤片治療RA患者的有效性和安全性。該研究擬入組140例受試者,由中國醫學科學院北京協和醫院牽頭,將在全國約17家中心進行。中華醫學會風濕病學分會前主任委員、中國醫師協會風濕免疫科醫師分會會長曾小峯教授擔任組長單位主要研究者,領銜國內風濕病領域權威專家團隊開展研究。
甲氨蝶呤注射液(預充式)
甲氨蝶呤注射液(預充式)為多種規格的小容量甲氨蝶呤(MTX)產品,採用皮下給藥,相較於口服MTX,擁有更低的副作用(尤其胃腸道不良反應較少),且具有較高的生物利用度、良好的臨牀應答、靈活的劑量管理和操作便捷等優勢,在療效、安全耐受性和依從性之間取得良好平衡。該產品已在歐洲獲批上市。
RA是主要的自身免疫性疾病之一,根據《中國類風濕關節炎診療規範(2021)》,中國RA的發生率為0.42%,患者總數約500萬。MTX是國際公認的RA系統性治療一線金標準和錨定藥物,但中國尚無用於治療RA的MTX注射劑獲批上市。甲氨蝶呤注射液(預充式)有望成為中國首個以皮下給藥治療RA的MTX預充式注射劑藥物,滿足RA患者基礎治療用藥需求。
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