创新联合疗法用于肾小球肾炎，HLX79联合汉利康II期临床完成首例患者给药

关于HLX01HLX79-GN201

本研究为一项双盲、随机对照、多中心的2期临床试验，旨在评估HLX79联合汉利康^®对比安慰剂在活动期肾小球肾炎（狼疮肾炎（LN）和膜性肾病（MN））患者中的有效性、安全性和耐受性。研究分为两个阶段，第一阶段为剂量递增期，按照剂量递增设计原则，合格的受试者将每周一次接受HLX79（10 mg/kg、20 mg/kg或30 mg/kg）联合汉利康^®或汉利康^®安慰剂（375 mg/m2）给药，主要研究目的为评价HLX79联合汉利康^®对比安慰剂联合汉利康^®治疗活动期肾小球肾炎的安全性和耐受性；第二阶段为初步疗效探索期，筛选合格的受试者将按照2:2:1:1的比例，每周一次接受HLX79（高剂量/低剂量）联合汉利康^®（375 mg/m2）、HLX79安慰剂联合汉利康^®、或HLX79安慰剂联合汉利康^®安慰剂给药，主要研究目的为在标准治疗基础上，评价HLX79联合汉利康^®、安慰剂联合汉利康^®以及安慰剂治疗活动期肾小球肾炎的临床疗效，次要研究目的为评估其他临床疗效、安全性、耐受性、药代动力学（PK）特征和免疫原性，探索性目的为评估潜在生物标志物的动态变化。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状^®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康^®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优^®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac^®）、汉达远^®（阿达木单抗）、汉贝泰^®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状^®（斯鲁利单抗，欧洲商品名：Hetronifly^®）以及汉奈佳^®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

About HLX01HLX79-GN201

This study is a double-blind, randomized, controlled, multicenter, Phase 2 study to evaluate the efficacy, safety, and tolerability of HLX79 in combination with HANLIKANG compared with placebo in patients with active glomerulonephritis (lupus nephritis (LN) and membranous nephropathy (MN)). The study includes two parts. Part 1 of the study is the dose escalation period. Eligible subjects will receive HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) or placebo combined with HANLIKANG (375 mg/m²) once a week. The primary objective is to evaluate the safety and tolerability of HLX79 in combination with HANLIKANG, and placebo in combination with HANLIKANG for glomerulonephritis. Part 2 of the study is the preliminary efficacy exploration period. Eligible subjects will receive HLX79 (high dose/low dose) combined with HANLIKANG (375 mg/m²), HLX79 placebo combined with HANLIKANG, or HLX79 placebo combined with HANLIKANG placebo once a  week at a ratio of 2:2:1:1. The primary objective of part 2 is to evaluate the clinical efficacy of HLX79 in combination with HANLIKANG, placebo in combination with HANLIKANG, as well as placebo alone, in subjects with glomerulonephritis on the basis of standard treatment. The secondary objectives include other clinical efficacy, safety, tolerability, pharmacokinetic (PK) characteristics, and immunogenicity. The exploratory objective is to evaluate the dynamic changes of potential biomarkers.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly^® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.