2026年2月11日，复星医药子公司复宏汉霖（2696.HK）宣布，一项评估公司创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43联合H药 汉斯状（斯鲁利单抗，抗PD-1单抗）或自研的重组抗EGFR单克隆抗体HLX07用于晚期/转移性结直肠癌（mCRC）治疗的Ib/II期临床研究（HLX43-mCRC202）于中国境内完成首例患者给药。目前，复宏汉霖正全力推进HLX43在全球范围内的临床开发进程，公司累计开展约十项HLX43单药或联合其他产品的临床研究，广泛覆盖肺癌（LC）、宫颈癌（CC）、食管鳞癌（ESCC）、头颈鳞癌（HNSCC）、鼻咽癌（NPC）、结直肠癌（mCRC）、胃癌/胃食管交界部（G/GEJ）癌、胰腺导管腺癌（PDAC）等，持续探索和挖掘HLX43在实体瘤中的广谱治疗潜力。

结直肠癌是我国乃至全球范围内高发的恶性肿瘤。2022年全球新发结直肠癌约192.6万例，死亡约90.4万例，我国新发及死亡病例达51.7和24.0万例，位居恶性肿瘤发病率的第二位，死亡率的第四位^1-2。对于晚期/转移性结直肠癌，其一、二线标准治疗方案主要为基于尿氟嘧啶类的化疗药物联合抗血管生成药物（抗VEGF靶向治疗）或抗EGFR靶向治疗。其中，RAS/BRAF野生型晚期结直肠癌患者，推荐联合抗EGFR靶向药物（如西妥昔单抗），MSI-H/dMMR患者则更易从PD-1抑制剂中获益。但当疾病进展至三线及以后，患者的治疗策略多受局限，且高度依赖于既往的治疗反应、体能状态（ECOG评分）及特定的分子分型^3-4。目前，晚期结直肠癌的后线治疗选择包括瑞戈非尼、呋喹替尼、TAS-102等口服靶向药物^5-7，以及近年来不断涌现的联合治疗策略。然而，患者的后线治疗获益整体较为有限，临床上亟需更为有效的治疗选择。

HLX43是一款潜在同类最优的广谱抗肿瘤PD-L1 ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。不同于市面上众多针对驱动基因突变的ADC，HLX43选择了PD-L1这一泛瘤种靶点，不依赖生物标志物的筛选，真正具备广谱ADC的开发潜力。HLX43的抗体骨架采用复宏汉霖自主研发的HLX20，具有抗原的高结合能力及肿瘤细胞的内吞效率，连接子—毒素引进自具有技术优势的宜联TMALIN平台，可裂解型连接子不仅通过内吞途径胞内释放毒素，还能够在肿瘤微环境中激活释放毒素，实现毒素于“胞内”和“胞外”的同时释放。目前，HLX43已在NSCLC中展现出“高效、低毒”的显著疗效，具备覆盖NSCLC全人群的治疗潜力。公司于全球范围内入组超过300例NSCLC患者（占全部患者超过60%），包括一项针对NSCLC的国际多中心II期临床研究（HLX43-NSCLC201）正在中、美、日、澳等地同步开展。此外，HLX43在宫颈癌、食管鳞癌等实体瘤中的II期POC验证数据也陆续读出，广谱治疗潜力持续夯实。为进一步挖掘该产品的临床价值，公司已同步启动HLX43联合斯鲁利单抗以及HLX43联合HLX07用于晚期实体瘤治疗的多项临床研究。

HLX07是复宏汉霖自主开发的创新型抗EGFR的单抗，相比西妥昔单抗该产品具备更低的免疫原性和更好的靶点亲和力。同时通过Fc端改造，显著延长半衰期，实现三周一次给药，有望提升联合治疗的便利性，保持持续的协同抗肿瘤效应。此前，HLX07联合化疗用于晚期实体瘤治疗的Ib/II期临床研究结果显示其安全性及耐受性良好，多项HLX07单药或联合H药汉斯状探索实体瘤治疗的II期临床试验正在同步开展。H药 汉斯状（斯鲁利单抗）是全球首个且唯一胃癌围手术期III期注册研究成功的抗PD-1单抗，获CDE突破性疗法认定且其上市许可申请正式纳入优先审评审批程序，同时是全球首个一线治疗小细胞肺癌的抗PD-1单抗。目前，该产品已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC) 等适应症。与此同时，其联合贝伐珠单抗和化疗用于一线治疗转移性结直肠癌（mCRC）的国际多中心III期临床研究正在全球多地同步开展。

未来，复宏汉霖将持续聚焦患者未满足的临床需求，立足于HLX43等核心创新管线，不断放大产品的差异化治疗潜力，加速推动更大临床价值的释放，为全球患者带来更具突破疗效的治疗方案。

【参考文献】

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.

2. Han B, Zheng R, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53.

3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer version 5.2025

4. 2025 CSCO结直肠癌诊疗指南

5. Grothey A, et al; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12.

6. Mayer R J, et al. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer[J]. New England Journal of Medicine, 2015, 372(20):1909-1919.

7. Li J, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients with Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486–2496.

关于 HLX43-mCRC202

本研究为一项Ib/II 期临床研究，旨在评估HLX43联合HLX07或汉斯状，在晚期或转移性结直肠癌患者中的安全性、耐受性和有效性。该研究包括两个部分：第一部分包括第一阶段（安全导入期）和第二阶段（剂量扩展）。第一阶段采用3+3剂量递增设计，患者将接受HLX43 2.5 mg/kg或3.0 mg/kg，联合固定剂量HLX07（1000 mg）每三周一次（Q3W）静脉输注给药。第一阶段主要目的为评估不同剂量水平HLX43联合HLX07在晚期或转移性结直肠癌患者中的安全性和耐受性，次要目的是研究HLX43的药代动力学（PK）特征和免疫原性、疗效、潜在药效学、潜在预测性或耐药性生物标志物。第二阶段是随机、多中心、开放标签研究，HLX43两个剂量水平分别联合固定剂量HLX07进行扩展，根据第一阶段安全性资料，暂定HLX43的剂量水平为 2.5 mg/kg和3.0 mg/kg，该阶段主要目的是研究不同剂量HLX43联合固定剂量HLX07在转移性结直肠癌（mCRC）患者中的有效性，次要目的包括评价其安全性和耐受性、HLX43的PK特征和免疫原性、并研究潜在预测性或耐药性生物标志物。第二部分为一项随机、多中心、开放标签研究，评估HLX43 2.0 mg/kg或2.5 mg/kg联合固定剂量汉斯状（300 mg）（Q3W）在mCRC患者中的有效性和安全性，该部分主要目的是研究HLX43联合固定剂量汉斯状在mCRC患者中的有效性，次要目的包括评价其安全性和耐受性、HLX43的PK特征和免疫原性、并研究潜在预测性或耐药性生物标志物。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EMA上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。

在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。

First Patient Dosed for a Phase 1b/2 Clinical Trial of PD-L1 ADC HLX43 Combination Therapy in Advanced Colorectal Cancer

February 11, 2026, Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in China in a Phase 1b/2 trial(HLX43-mCRC202), for the company's innovative programmed death-ligand 1 (PD-L1) antibody-drug conjugate (ADC), HLX43, in combination with serplulimab, an anti-PD-1 monoclonal antibody (mAb) or independently developed recombinant anti-EGFR mAb HLX07 in patients with advanced or metastatic colorectal cancer (mCRC). Henlius is vigorously advancing the clinical development of HLX43 globally, with its pan-tumor activity being explored  across 10 clinical studies in various solid tumors, including non-small cell lung cancer‌(NSCLC), cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), mCRC, gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and pancreatic ductal adenocarcinoma (PDAC).

Colorectal cancer is a highly prevalent malignancy both in China and globally. In 2022, there were approximately 1.926 million new cases and 904,000 deaths worldwide, with China accounting for 517,000 new cases and 240,000 deaths, ranking second in incidence and fourth in mortality among all cancers^1-2. For patients with advanced or metastatic colorectal cancer, the first- and second-line standard treatments primarily involve chemotherapy regimens based on fluoropyrimidines combined with either anti-angiogenic agents (anti-VEGF targeted therapy, e.g., bevacizumab) or anti-EGFR targeted therapy. Specially, for patients with RAS/BRAF wild-type mCRC, combination therapy with anti-EGFR targeted agents like cetuximab is recommended. Patients with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) mCRC are more likely to benefit from PD-1 inhibitors. However, when the disease progresses to the third-line setting and beyond, treatment strategies become more limited and are highly dependent on the patient's prior treatment response, performance status (e.g., ECOG score), and specific molecular subtypes^3-4. Current later-line treatment options for advanced colorectal cancer include oral targeted drugs such as regorafenib, fruquintinib, and TAS-102^5-7 , as well as emerging combination strategies. Nonetheless, the clinical benefits for patients in later-line settings remain generally limited, highlighting an urgent unmet need for more effective treatment options.

HLX43 is a potentially best-in-class pan-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Compared to ADCs that target driver mutations, HLX43 engages the pan-tumor target PD-L1, demonstrating biomarker-independent and broad-spectrum anti-tumor potential. Its antibody backbone is derived from Henlius's proprietary anti-PD-L1 antibody, HLX20, ensuring high antigen binding and efficient tumor cell internalization. The cleavable linker-payload is licensed from MedLink’s TMALIN platform, enables cytotoxic release both intracellularly post-internalization and within the tumor microenvironment. Currently, it has demonstrated manageable safety profile and encouraging efficacy in various solid tumors, with notable anti-tumor activity observed in various NSCLC patient subgroups. The company has enrolled more than 300 NSCLC patients globally(accounting for over 60% of the total enrolled population), with an international multicenter Phase 2 clinical trial for NSCLC (HLX43-NSCLC201) underway in countries including China, the United States, Japan, and Australia. In addition, phase 2 proof of concept (POC) data of HLX43 in CC and ESCC continue to emerge, providing compelling new evidence for its pan-tumor therapeutic potential. To further maximize the clinical value of the product, the company has simultaneously initiated multiple clinical trials evaluating HLX43 in combination with serplulimab, as well as with HLX07, for the treatment of advanced solid tumors.

HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. Fc engineering extends its half-life, enabling every-3-week dosing that facilitates combination with other agents and promotes synergistic anti-tumor efficacy. The Phase 1b/2 clinical study of HLX07 in combination with chemotherapy for the treatment of advanced solid tumors demonstrated favorable safety and tolerability. Additionally, Phase 2 clinical trials evaluating HLX07 as a monotherapy or in combination with serplulimab for the treatment of solid tumors are currently underway. Serplulimab is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, to receive Breakthrough Therapy Designation from the CDE as well as being granted Priority Review for the treatment of this indication. Meanwhile, it is the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). Up to date, serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), ESCC, and non-squamous non-small cell lung cancer (nsqNSCLC). Meanwhile, an international multicenter Phase 3 clinical trial of serplulimab in combination with bevacizumab and chemotherapy as a first-line treatment for mCRC is in progress globally.

Guided by its commitment to address unmet medical needs, Henlius will continue to advance its core pipeline including HLX43 to deepen the differentiated therapeutic potential of our products, accelerate the delivery of greater clinical value, and ultimately deliver more breakthrough treatment options to patients worldwide.

About HLX43-mCRC202

This study is a phase 1b/2 clinical trial evaluating the safety, tolerability, and efficacy of HLX43 in combination with HLX07 or HANSIZHUANG  in patients with advanced or metastatic colorectal cancer. The study consists of two parts. Part 1 includes Stage 1 (safety run-in) and Stage 2 (dose expansion). Stage 1 adopts a 3+3 dose‑escalation design, in which patients will receive HLX43 at 2.5 mg/kg or 3.0 mg/kg combined with a fixed dose of HLX07 (1000 mg), administered by intravenous infusion once every three weeks (Q3W). The primary objective of Stage 1 is to evaluate the safety and tolerability of different dose levels of HLX43 in combination with HLX07 in patients with advanced or metastatic colorectal cancer. Secondary objectives include assessment of the pharmacokinetic (PK) characteristics and immunogenicity of HLX43, evaluation of efficacy, potential pharmacodynamic effects, and potential predictive or resistance biomarkers. Stage 2 is a randomized, multicenter, open‑label study. HLX43 at two dose levels will be expanded in combination with a fixed dose of HLX07. Based on safety data from the Stage 1, the dose levels of HLX43 are preliminarily set at 2.5 mg/kg and 3.0 mg/kg. The primary objective of Stage 2 is to evaluate the efficacy of different doses of HLX43 in combination with fixed‑dose HLX07 in metastatic colorectal cancer (mCRC) patients. Secondary objectives include evaluation of safety and tolerability, the PK characteristics and immunogenicity of HLX43, and potential predictive or resistance biomarkers. Part 2 is a randomized, multicenter, open‑label study to evaluate the efficacy and safety of HLX43 at 2.0 mg/kg or 2.5 mg/kg in combination with a fixed dose of HANSIZHUANG  (300 mg), Q3W, in patients with mCRC. The primary objective of Part 2 is to assess the efficacy of HLX43 in combination with HANSIZHUANG  in mCRC patients. Secondary objectives include evaluation of safety and tolerability, the PK characteristics and immunogenicity of HLX43, and exploration of potential predictive or resistance biomarkers.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products authorized by the European Medicines Agency (EMA), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit and connect with us on LinkedIn at

(复星医药 动态宝)