2026年6月30日 – 复宏汉霖(2696.HK)宣布，公司自主研发的靶向c-MET和EGFR的双特异性抗体偶联药物(ADC)注射用 HLX48(c-MET x EGFR 双抗 ADC)I 期临床研究(HLX48-FIH101)于中国完成首例患者给药。该研究是一项在晚期/转移性实体瘤患者中评估HLX48的安全性、耐受性、药代动力学特征及初步疗效的开放性、剂量递增、首次人体的1期临床研究。此前，HLX48已于2026年5月先后在中国和澳大利亚获批开展临床试验，公司将在中澳两地同步推进HLX48的I期临床开发。

c-MET(由MET基因编码的中间质-上皮转化因子)和EGFR(表皮生长因子受体)均为受体酪氨酸激酶，在多种实体瘤中异常表达或激活，且MET扩增被认为是 EGFR 靶向治疗获得性耐药的主要原因1。因此，同时靶向c-MET与EGFR被视为克服耐药、提升治疗应答的关键策略。目前，EGFR/c-MET 双特异性抗体在肿瘤治疗中展现了初步疗效，但仍存在应答率有限、疾病易进展等挑战2。双特异性抗体偶联药物(双抗 ADC)有望通过抗体的精准靶向性与细胞毒载荷的高效杀伤作用实现协同增效，提供更高效的治疗方案3。

HLX48是复宏汉霖基于Hanjugator™ ADC平台自主研发的新型ADC候选药物，由c-METxEGFR双抗与喜树碱类DNA拓扑异构酶I抑制剂类毒素偶联而成，具备同类最优(Best-in-class)的治疗潜力。分子设计上，HLX48采用了高亲水性基团连接策略与中等效力的载荷设计，抗体药物比(Drug-to-Antibody Ratio, DAR)约为4，旨在实现强大抗肿瘤活性与可管理毒性的最佳平衡，从而最大化临床给药剂量，充分发挥双抗的信号阻断和免疫调节等功能。同时，通过特有的亲和力差异化设计，HLX48对c-MET的亲和力高于EGFR，使其能够优先靶向在肿瘤中常异常高表达的c-MET，降低因EGFR在正常组织中广泛表达引发的靶向相关性毒性，潜在地拓宽治疗窗。此外，得益于连接子-载荷的优化设计，HLX48经内吞后释放的毒素具有较强的旁观者杀伤效应，可扩散至邻近抗原低表达或无表达的肿瘤细胞，在一定程度上克服肿瘤异质性问题，增强其整体抗肿瘤活性。临床前药理学研究证明，HLX48在多种肿瘤模型中展现出显著的抗肿瘤活性，其偶联物展现出较 DXd 高 10 倍以上的旁观者杀伤效应，并在食蟹猴中以 60 mg/kg、每 3 周一次(Q3W)给药 3 次的初步毒理研究中显示出良好的耐受性。

HLX48的差异化设计，源自复宏汉霖自主研发的新一代抗体偶联药物(ADC)技术平台——Hanjugator™。Hanjugator™采用高亲水性喜树碱连接子-载荷设计，可适配不同靶点特性灵活调节载荷效力，在充分保留抗体生物学功能的基础上，协同提升抗肿瘤活性并拓宽治疗窗口。同时，平台支持多种作用机制的毒素组合，差异化载荷设计有助于克服常见毒素耐药，为下一代ADC药物的开发提供具有差异化的解决方案。依托该平台，公司已孵化了超过12款具备同类最优(Best-in-class)或同类首个(First-in-class)治疗潜力的新一代ADC分子，包括HLX48(c-MET x EGFR双抗ADC)、HLX49(HER2双表位ADC)、HLX403(CDH17 ADC)、HLX402(ADAM9 ADC)、HLX85(ALPP/ALPPL2 ADC)等，并持续加速推进更多分子至临床阶段。

未来，复宏汉霖还将持续立足于未满足的临床需求，充分发挥公司在抗体药物领域的一体化平台优势，不断拓展疾病领域和新分子类型，为全球患者带来更多高质量、可负担的创新治疗方案。

关于HLX48-FIH101研究

本研究是一项评估HLX48在晚期/转移性实体瘤受试者中安全性、耐受性、药代动力学(PK)特征及初步疗效的开放性、剂量递增、首次人体的1期临床研究。本研究设置1.5mg/kg至15 mg/kg共6个剂量组，受试者将接受不同剂量的HLX48单药每三周一次(Q3W)静脉输注给药，每个剂量组的所有受试者完成给药和21天的安全性观察期后，由安全性评估委员会(SRC)评估决定是否进入下一剂量组。本研究的主要终点旨在评估剂量限制性毒性(DLT)的发生率，以确定HLX48单药的最大耐受剂量(MTD);次要终点包括不良事件等安全性指标、PK参数、免疫原性、客观缓解率(ORR)、无进展生存期(PFS)和总生存期(OS)等疗效指标。

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。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8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、5款产品获得欧盟EC批准，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和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球50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(通用名：dulpatatug)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。

Henlius Doses First Patient with c-MET x EGFR Bispecific ADC HLX48

June 30, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that that the first patient has been dosed in a phase 1 clinical study (HLX48-FIH101) of its independently developed c-METxEGFR bispecific antibody–drug conjugate (ADC), HLX48 for injection, in China. for the treatment of advanced and metastatic solid tumors. This open-label, dose-escalation, first-in-human phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) profiles, and preliminary efficacy of HLX48 in patients with advanced/metastatic solid tumors. Previously, HLX48 received regulatory approval to initiate clinical trials in both China and Australia in May 2026. The company will advance the phase 1 clinical development of HLX48 across both regions.

EGFR (epidermal growth factor receptor) and c-MET (mesenchymal-epithelial transition factor, encoded by the MET gene) are receptor tyrosine kinases frequently dysregulated in a variety of solid tumors. MET amplification has been recognized as a key mechanism driving acquired resistance to EGFR-targeted therapies.1 Accordingly, dual inhibition of EGFR and c-MET represents a strategic approach to overcome resistance and enhance clinical response. Despite promising preliminary clinical activity, EGFR/c-MET bispecific antibodies face limitations in response rates and disease control.2 Bispecific antibody–drug conjugates (bispecific ADCs) are designed to deliver synergistic anti-tumor effects by combining precise antibody targeting with potent cytotoxic payloads, providing a potentially more effective therapeutic option.3

HLX48 is a novel ADC candidate independently developed by Henlius based on its proprietary Hanjugator™ ADC platform. It consists of a c-METxEGFR bispecific antibody conjugated to a camptothecin-based DNA topoisomerase I inhibitor payload, with best-in-class therapeutic potential. The molecule features a highly hydrophilic linker strategy and a moderate-potency payload, with a drug-to-antibody ratio (DAR) of approximately 4, designed to achieve an optimal balance between robust anti-tumor activity and manageable toxicity. This enables maximized clinical dosing while fully leveraging the bispecific antibody’s signal-blocking and immunomodulatory functions. In addition, HLX48 is engineered with an affinity-differentiated design, exhibiting higher affinity for c-MET than EGFR, allowing preferential targeting of tumors with high c-MET expression while potentially reducing target-related toxicity associated with EGFR expression in normal tissues and thereby broadening the therapeutic window. Moreover, the optimized linker-payload design enables strong bystander killing: once internalized, the released cytotoxin can diffuse to adjacent tumor cells with low or no antigen expression, helping to overcome tumor heterogeneity and enhancing overall anti-tumor efficacy.

Preclinical pharmacological studies have demonstrated that HLX48 exhibits significant anti-tumor activity in multiple tumor models. Its conjugate exhibits bystander killing over 10-fold stronger compared with deruxtecan. In preliminary toxicology studies, HLX48 showed good tolerability in cynomolgus monkeys at 60 mg/kg administered once every three weeks (Q3W) for three doses.

HLX48 derives its differentiated design from Hanjugator™, Henlius' proprietary next-generation ADC platform. Hanjugator™ employs a highly hydrophilic camptothecin-based linker–payload system that can flexibly tune payload potency across different targets. The platform preserves antibody biological functions while synergistically enhancing anti-tumor activity and expanding the therapeutic window. It also supports multiple cytotoxic mechanisms, and differentiated payload design may help overcome common drug resistance, providing a differentiated solution for next-generation ADC development. Leveraging this platform, the Company has independently developed more than 12 next-generation ADC assets with Best-in-class or First-in-class potential, including HLX48 (c-MET x EGFR bispecific ADC), HLX49 (HER2 biparatopic ADC), HLX403 (CDH17 ADC), HLX402 (ADAM9 ADC) and HLX85 (ALPP/ALPPL2 ADC). The company continues to accelerate the advancement of additional candidates into clinical development.

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 HLX48-FIH101

This study is an open-label, first-in-human phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetic (PK) profiles, and preliminary efficacy of HLX48 in subjects with advanced/metastatic solid tumors. The study includes six dose cohorts ranging from 1.5 mg/kg to 15 mg/kg. Eligible subjects will receive intravenous (IV) infusions of HLX48 monotherapy at specified dose levels administered once every three weeks (Q3W). Following the completion of dosing and a 21-day safety observation period for all subjects in a given cohort, the Safety Review Committee (SRC) will evaluate the data to determine whether to initiate the next dose level. The primary endpoints aim to evaluate the incidence of dose-limiting toxicity (DLT) to determine the maximum tolerated dose (MTD) of HLX48 monotherapy. Secondary endpoints include safety indicators such as adverse events, PK parameters, and immunogenicity, as well as efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS), alongside the exploration of potential predictive 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. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight 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 five products approved by the European Commission (EC), 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 for perioperative gastric cancer. Up to date, it has been approved in 50 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 dulpatatug (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 https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.