2025年8月6日kaiyun官方网站，复宏汉霖（2696.HK）文书，潜在同类始创（first-in-class）东谈主唾液酸酶交融卵白HLX79（E-602）聚会汉利康（利妥昔单抗）诊治行径期肾小球肾炎的II期临床熟识（HLX01HLX79-GN201）于中国完成首例患者给药。汉利康现已在中国获批用于诊治非霍奇金淋巴瘤（NHL）、慢性淋巴细胞白血病（CLL）、类风湿性时弊炎（RA），是当今国内唯独获批用于本人免疫疾病诊治的利妥昔单抗。此外，汉利康亦在拉好意思多国获批用于诊治血管炎肉芽肿（GPA）、显微镜下多血管炎（MPA）和寻常型天疱疮（PV）等本人免疫疾病。

临了期肾病（ESRD）是慢性肾脏病（CKD）的临了阶段，这一阶段患者肾功能险些彻底丧失，需长期依靠肾脏替代诊治保管生命，具有疾病严重进度高、多并发症高发、诊治破耗职守重等特色[1]。中国ESRD患者数目位居环球首位，占比接近30%，折合现存患者东谈主数达350万[2]。而中国临了期肾病的主要病因为肾小球肾炎，包括原发性肾小球肾炎和继发性肾小球肾炎。原发性肾小球肾炎包括膜性肾病（MN）、局灶节段性肾小球硬化（FSGS）等。继发性肾小球肾炎包括狼疮肾炎（LN）、抗中性粒细胞胞质抗体（ANCA）干系性血管炎（AAV）肾损害等[1]。

比年来，以利妥昔单抗（抗CD20单抗）等靶向抗体为代表的B细胞废除疗法，已在环球多个市集获批并被中华医学会肾脏病学民众共鸣推遴选于诊治肾小球肾炎[1]。然而，很多患者对这类药物的诊治响应并不睬思。糖免疫提供了一种诊治本人免疫疾病的新风景。该政策通过酶解唾液酸糖苷，冲破致病性免疫细胞的“保护障蔽”， 从而增强其废除恶果，匡助收复机体免疫均衡。

HLX79是基于Palleon的EAGLE糖剪辑平台斥地的潜在“同类始创”的东谈主唾液酸酶交融卵白。HLX79 通过酶解唾液酸糖苷，从而增强对两类在本人免疫疾病中高度致病的免疫细胞的废除：一是运转炎症的本人响应性缅想B细胞，二是促进纤维化和器官损害的M2型巨噬细胞。

临床前筹商标明，与利妥昔单抗单药比较，HLX79与利妥昔单抗联用的疗效显贵擢升，且不会激发CAR-T疗法或T细胞结合剂干系的细胞因子开释详细征（CRS）或免疫效应细胞干系神经毒性详细征（ICANS）。在此前的临床熟识中，HLX79展现出渊博的安全性特征，无剂量适度性毒性。HLX79联用利妥昔单抗有望为行径期肾小球肾炎患者带驾临床获益。

将来，复宏汉霖还将握续藏身于未满足的临床需求，充瓦解析公司在抗体药物限度的一体化平台上风，不休拓展疾病限度和新分子类型，为环球患者带来更多高质料、可职守的翻新诊治有蓄意。

参考文件

[1] 中华医学会肾脏病学分会民众组. 利妥昔单抗在肾小球肾炎中诳骗的民众共鸣[J]. 中华肾脏病杂志, 2022, 38(2):151-160. [2] IQVIA《中国临了期肾病白皮书》

对于HLX01HLX79-GN201

本筹商为一项双盲、立时对照、多中心的2期临床熟识，旨在评估HLX79聚会汉利康对比安危剂在行径期肾小球肾炎（狼疮肾炎（LN）和膜性肾病（MN））患者中的有用性、安全性和耐受性。筹商分为两个阶段，第一阶段为剂量递加期，按照剂量递加瞎想原则，及格的受试者将每周一次罗致HLX79（10 mg/kg、20 mg/kg或30 mg/kg）聚会汉利康或汉利康安危剂（375 mg/m2）给药，主要筹商办法为评价HLX79聚会汉利康对比安危剂聚会汉利康诊治行径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，筛选及格的受试者将按照2:2:1:1的比例，每周一次罗致HLX79（高剂量/低剂量）聚会汉利康（375 mg/m2）、HLX79安危剂聚会汉利康、或HLX79安危剂聚会汉利康安危剂给药，主要筹商办法为在标准诊治基础上，评价HLX79聚会汉利康、安危剂聚会汉利康以及安危剂诊治行径期肾小球肾炎的临床疗效，次要筹商办法为评估其他临床疗效、安全性、耐受性、药代能源学（PK）特征和免疫原性，探索性办法为评估潜在生物标识物的动态变化。

对于复宏汉霖

复宏汉霖（2696.HK）是一家海外化的翻更生物制药公司，勤恳于为环球患者提供可职守的高品性生物药，居品笼罩肿瘤、本人免疫疾病、眼科疾病等限度，已有6款居品在中国获批上市，4款居品在海外获批上市，5个上市央求别离获中国药监局、好意思国FDA和欧盟EMA受理。自2010年设立以来，复宏汉霖已建成一体化生物制药平台，高效及翻新的自主中枢才智联接研发、坐蓐及买卖运营全产业链。公司已建设完善高效的环球翻新中心，按照海外药品坐蓐质料贬责标准（GMP）标准进行坐蓐和质料管控，不休夯实一体化详细坐蓐平台，其中，公司买卖化坐蓐基地已接踵取得中国、欧盟和好意思国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质料的居品管线，涵盖约50个分子，并全面激动基于自有抗PD-1单抗H药汉斯状的肿瘤免疫聚会疗法。收尾当今，公司已获批上市居品包括国内首个生物近似药汉利康（利妥昔单抗）、自主研发的中好意思欧三地获批单抗生物近似药汉曲优（曲妥珠单抗，好意思国商品名：HERCESSI，欧洲商品名：Zercepac）、汉达远（阿达木单抗）、汉贝泰（贝伐珠单抗）、环球首个获批一线诊治小细胞肺癌的抗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个居品在环球领域内开展30多项临床熟识，对外授权全面笼罩泰西主流生物药市集和繁密新兴市集。

Henlius Doses First Patient in Phase 2 Trial of HLX79 and HANLIKANG for Glomerulonephritis

Shanghai, China, August 6, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (HLX01HLX79-GN201) for the potential first-in-class human sialidase enzyme therapeutic, HLX79 (E-602), in combination with Henlius’ self-developed HANLIKANG (rituximab) in patients with active glomerulonephritis.

End stage renal disease (ESRD), the last stage of chronic kidney disease (CKD), is characterised by near-total loss of kidney function, resulting in the need for renal replacement therapy. Patients face high disease severity, complications, and substantial economic burden due to the costs of treatment[1]. China accounts for nearly 30% of global ESRD cases, with approximately 3.5 million patients[2]. Glomerulonephritis can be classified into primary forms (e.g., membranous nephropathy [MN], focal segmental glomerulosclerosis [FSGS]) and secondary forms (e.g., lupus nephritis [LN], anti-neutrophilic cytoplasmic antibodies [ANCA]-associated vasculitis [AAV]), representing the leading cause of ESRD in China[1].

HANLIKANG, approved in China for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, remains the only rituximab approved for an autoimmune indication in China. Depleting B cells with targeted antibodies such as rituximab (anti-CD20 mAb), has been approved in multiple markets for the treatment of glomerulonephritis. However, many patients have inadequate response to these drugs. Glyco-immunology provides a new approach to treating autoimmunity by degrading immune-inhibitory sialoglycan sugar molecules that help pathogenic immune cells evade immune clearance to enhance their depletion and restore immune balance.

HLX79 is a potential first-in-class human sialidase enzyme therapeutic developed based on Palleon’s EAGLE glycan editing platform and licensed in China by Henlius from Palleon. HLX79 degrades sialic acid, enhancing the clearance of two highly pathogenic immune cell populations in autoimmunity: autoreactive memory B cells, which drive inflammation, and M2-like macrophages, which promote fibrosis and organ damage. Preclinical studies of HLX79 in combination with rituximab demonstrate improved outcomes versus rituximab alone without the risk of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) associated with CAR T and T cell engagers. HLX79 has demonstrated a favourable safety profile with no dose-limiting toxicities in human clinical trials. It is expected that the combination of HANLIKANG and HLX79 will benefit patients with active glomerulonephritis.

Moving forward, Henlius will continue to focus on unmet clinical needs by fully leveraging its integrated platform advantages in antibody-based drugs, expanding disease areas, accelerating the development of differentiated molecules, and bringing more high-quality, affordable innovative therapies to patients worldwide.

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.

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