复宏汉霖-B(02696.HK)：3期临试结果显示，HLX03与原研阿达木单抗的疗效相当、安全性和免疫原性特征相似
格隆汇 10 月 29日丨复宏汉霖-B(02696.HK)宣布，今日，公司自主开发的HLX03(阿达木单抗注射液)("HLX03")的3期临床研究数据以电子海报形式于2020年第二十九届欧洲皮肤病与性病学会年会("EADV")大会线上平台发布。
一项比较生物类似药HLX03与阿达木单抗在中国中重度斑块状银屑病患者中的疗效、安全性和免疫原性的随机、双盲的3期等效临床试验
(A)试验设计
HLX03-Ps03是一项多中心、随机、双盲、平行对照的3期临床试验(临床试验号：NCT03316781)，旨在比较HLX03与原研阿达木单抗在中国中重度斑块状银屑病患者中的疗效、安全性和免疫原性差异。纳入的患者按照1:1的比例随机分为两组，通过皮下注射HLX03或原研阿达木单抗进行给药。第1周第1天药物初始剂量为80mg，第2周第1天药物剂量调整为40mg，此后直至第48周，药物剂量为每2周一次，每次40mg。本试验的主要研究终点为第16周时银屑病面积与严重程度指数(PASIwk16)相对於基线改善的百分比。
(B)试验结果
1)有效性a)
主要终点
本试验入组了262例病患(HLX03组，n=132；原研组，n=130)。在全分析集(FAS)中，HLX03组和原研组PASIwk16相对于基线改善的百分比分别为83.48%和82.02%。两组的最小二乘均差为1.46%(95%置信区间：-3.86%，6.79%)，落於预先设定的等效界值(±15%)范围之内，证明HLX03和原研阿达木单抗的疗效相似。
b)次要终点
试验结果显示，两治疗组的次要终点(包括PASI相对於基线至少改善75%的患者比例、PASI相对於基线改善的百分比、医生整体评价(PGA)达到清除或几乎清除的受试者比例、皮肤生活质量指数(DLQI)较基线变化)在第4、8、12、16、20、32、50周均无统计学差异。2)安全性及免疫原性HLX03和原研阿达木单抗的安全性和免疫原性特徵相似。
(C)结论
3期临床试验结果显示，HLX03与原研阿达木单抗的疗效相当、安全性和免疫原性特徵相似。HLX03作为阿达木单抗生物类似药候选药有望为中重度斑块状银屑病患者带来更多治疗选择。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
