2025年8月6日，复宏汉霖（2696.HK）晓谕，潜在同类始创（first-in-class）东说念主唾液酸酶和会卵白HLX79（E-602）长入汉利康（利妥昔单抗）调赡养动期肾小球肾炎的II期临床西宾（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调养非霍奇金淋巴瘤（NHL）、慢性淋巴细胞白血病（CLL）、类风湿性重要炎（RA），是现在国内唯独获批用于自己免疫疾病调养的利妥昔单抗。此外，汉利康亦在拉好意思多国获批用于调养血管炎肉芽肿（GPA）、显微镜下多血管炎（MPA）和寻常型天疱疮（PV）等自己免疫疾病。

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透彻丧失，需长久依靠肾脏替代调养保管人命，具有疾病严重流程高、多并发症高发、调养破耗包袱重等特质[1]。中国ESRD患者数目位居公共首位，占比接近30%，折合现存患者东说念主数达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）关系性血管炎（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细胞撤消疗法，已在公共多个市集获批并被中华医学会肾脏病学大众共鸣保举用于调养肾小球肾炎[1]。然而，好多患者对这类药物的调养响应并不睬思。糖免疫提供了一种调养自己免疫疾病的新设施。该计谋通过酶解唾液酸糖苷，冲破致病性免疫细胞的“保护障蔽”， 从而增强其撤消收尾，匡助复原机体免疫均衡。

HLX79是基于Palleon的EAGLE糖裁剪平台开发的潜在“同类始创”的东说念主唾液酸酶和会卵白。HLX79 通过酶解唾液酸糖苷，从而增强对两类在自己免疫疾病中高度致病的免疫细胞的撤消：一是运行炎症的自己响应性挂念B细胞，二是促进纤维化和器官毁伤的M2型巨噬细胞。

临床前商榷标明，与利妥昔单抗单药比较，HLX79与利妥昔单抗联用的疗效权贵擢升，且不会激发CAR-T疗法或T细胞联接剂关系的细胞因子开释轮廓征（CRS）或免疫效应细胞关系神经毒性轮廓征（ICANS）。在此前的临床西宾中，HLX79展现出邃密的安全性特征，无剂量适度性毒性。HLX79联用利妥昔单抗有望为四肢期肾小球肾炎患者带驾临床获益。

未来，复宏汉霖还将捏续立足于未得志的临床需求，充分阐扬公司在抗体药物限制的一体化平台上风，束缚拓展疾病限制和新分子类型，为公共患者带来更多高质地、可包袱的改革调养有谋略。

参考文件

[1] 中华医学会肾脏病学分会大众组. 利妥昔单抗在肾小球肾炎中期骗的大众共鸣[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

本商榷为一项双盲、连忙对照、多中心的2期临床西宾，旨在评估HLX79长入汉利康对比抚慰剂在四肢期肾小球肾炎（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。商榷分为两个阶段，第一阶段为剂量递加期，按照剂量递加假想原则，及格的受试者将每周一次禁受HLX79（10 mg/kg、20 mg/kg或30 mg/kg）长入汉利康或汉利康抚慰剂（375 mg/m2）给药，主要商榷观点为评价HLX79长入汉利康对比抚慰剂长入汉利康调赡养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，筛选及格的受试者将按照2:2:1:1的比例，每周一次禁受HLX79（高剂量/低剂量）长入汉利康（375 mg/m2）、HLX79抚慰剂长入汉利康、或HLX79抚慰剂长入汉利康抚慰剂给药，主要商榷观点为在措施调养基础上，评价HLX79长入汉利康、抚慰剂长入汉利康以及抚慰剂调赡养动期肾小球肾炎的临床疗效，次要商榷观点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，探索性观点为评估潜在生物绚烂物的动态变化。

对于复宏汉霖

复宏汉霖（2696.HK）是一家海外化的改革生物制药公司，起劲于为公共患者提供可包袱的高品性生物药，家具遮盖肿瘤、自己免疫疾病、眼科疾病等限制，已有6款家具在中国获批上市，4款家具在海外获批上市，5个上市央求离别获中国药监局、好意思国FDA和欧盟EMA受理。自2010年树立以来，复宏汉霖已建成一体化生物制药平台，高效及改革的自主中枢智商联接研发、坐蓐及交易运营全产业链。公司已开垦完善高效的公共改革中心，按照海外药品坐蓐质地措置法度（GMP）措施进行坐蓐和质地管控，束缚夯实一体化轮廓坐蓐平台，其中，公司交易化坐蓐基地已接踵得到中国、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、高质地的家具管线，涵盖约50个分子，并全面鼓吹基于自有抗PD-1单抗H药汉斯状的肿瘤免疫长入疗法。摈弃现在，公司已获批上市家具包括国内首个生物相同药汉利康（利妥昔单抗）、自主研发的中好意思欧三地获批单抗生物相同药汉曲优（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）、公共首个获批一线调养小细胞肺癌的抗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个家具在公共畛域内开展30多项临床西宾，对外授权全面遮盖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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