2026年7月10日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自研的HLX37（重组人源化抗PD-L1与VEGF双特异性抗体）单药及联合化疗或创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43用于晚期/转移性实体瘤治疗的I期临床研究获中国国家药品监督管理局（NMPA）批准。该分子探索晚期/转移性实体瘤治疗的I期临床研究正在同步进行中。
HLX37：差异化PD-L1xVEGF双抗，夯实下一代IO治疗基础
近年来，以PD-1/L1抑制剂为代表的免疫检查点抑制剂（ICI）促进了肿瘤免疫治疗（IO）的高速发展，在多项实体瘤中确立了一线治疗标杆地位。然而，尽管临床应用日趋广泛，PD-1/PD-L1抑制剂单药治疗的客观缓解率相对有限，且常因适应性耐药及T细胞功能耗竭等因素导致疾病复发或进展1，由此推动了下一代IO治疗策略的探索。诸多前沿方向中，以PD-(L)1/VEGF双抗为代表的免疫激活联合抗血管生成治疗正显现出明确的协同潜力。一方面，抗PD-(L)1免疫治疗致力于逆转T细胞的抑制状态，恢复其抗肿瘤活性，另一方面，VEGF 驱动的肿瘤血管发育不全会导致缺氧和酸性微环境，加剧T细胞耗竭，而抗血管生成药物通过重塑肿瘤血管结构，可改善免疫细胞的浸润效率及药物递送，从而增强抗PD-1/PD-L1治疗的疗效2-3。该双靶向策略有望突破当前疗法的疗效局限，使PD-(L)1/VEGF双抗成为下一代肿瘤免疫治疗的潜在基石4。
HLX37 是复宏汉霖自研的重组人源化抗PD-L1 与 VEGF 双特异性抗体。其作用机制结合了 1）阻断PD-1 /PD-L1结合与 2）阻断血管生成通路两种治疗路径，这种双靶点设计有望产生协同抗肿瘤效应，并可能降低耐药性风险，通过特异性结合肿瘤细胞PD-L1实现肿瘤内部具有抗VEGF功能的HLX37 双抗分子的富集，实现大于抗PD-L1 单抗和抗VEGF 单抗的联合疗效。临床前研究表明，HLX37具有优异的抗肿瘤活性且安全性可控，同时能增强肿瘤富集效应，其在多类肿瘤中具有广泛的应用潜力，该研究结果在2025年美国癌症研究协会（AACR）年会上首次发布5。
HLX43：潜在同类最优PD-L1 ADC，拓展IO+ADC治疗边界
与此同时，随着IO治疗边界的持续拓展——从IO单药到“IO+化疗”成为标准治疗范式，再到“IO+ADC（抗体偶联药物）”的前沿探索，联合治疗已成为提升IO临床获益的核心路径。当前，以“PD-(L)1抑制剂联合化疗”为代表的一线治疗策略已被纳入多项肿瘤的标准治疗方案6-7，在此基础上，多项大型临床研究也进一步表明，在非小细胞肺癌、消化道等肿瘤中，PD-(L)1xVEGF双抗联合化疗展现出超越PD-(L)1抑制剂联合化疗的显著生存获益。此外，近年来ADC在肿瘤治疗中展现出卓越的临床疗效8，从作用机制上看，PD-(L)1xVEGF双抗与ADC具备协同用药基础，已公布的多项临床数据也初步验证了其联用的协同增效潜力，进一步支持了这一联合策略的可行性9-10。
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。目前，HLX43在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效，尤其在NSCLC的治疗上展现了全人群覆盖的潜力。复宏汉霖正全力推进HLX43的临床开发进程，已累计开展十余项HLX43单药或联合其他产品的临床研究，广泛覆盖宫颈癌（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）、乳腺癌（BC）等，累计在全球入组患者逾1000例，持续探索和挖掘HLX43在实体瘤中的广谱治疗潜力。单药之外，公司也在积极探索HLX43与其他多元分子如公司自研创新抗EGFR单抗pimurutamab（HLX07）、抗PD-1单抗H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）等产品的联合治疗策略，以进一步评估其在更前线治疗及不同联合场景中的应用潜力。
平台赋能：以联合矩阵构建IO 2.0竞争力
目前，复宏汉霖已建立起覆盖“源头发现到规模化生产”全链条的一体化抗体研发平台，包括以PD-(L)1为核心的下一代IO平台，成为驱动差异化抗体药物持续创新的核心引擎。
在分子发现端，抗体研发平台聚焦功能阻断性抗体开发，拥有天然、合成人源化及免疫羊驼VHH等多样化抗体库，可针对不同靶点灵活筛选高亲和力、高特异性的纳米抗体（VHH）及scFv，为多特异性抗体等创新分子的早期发现提供源头活水。与此同时，基于长期行业积淀，公司已系统性构建了多特异性抗体（双抗/三抗/四抗）及抗体融合蛋白的构型设计与功能表征数据库，显著提升了复杂抗体分子的开发效率与成功率。在临床与产业化端，依托抗体研发平台的高效转化能力，公司已累计实现10款产品获批上市，并持续推进19款临床阶段资产（涵盖创新单抗、ADC、融合蛋白及生物类似药）的高效开发，在研临床项目超过30项。在CMC（化学、生产和控制）方面，公司基于长期积淀，已建立起具备复杂分子开发实力的技术体系，覆盖从分子发现到产业化转化的全链条能力。研发实力与经充分验证的质量体系协同驱动，持续加速潜力候选分子向高质量临床与商业化产品的转化。
未来，复宏汉霖将继续秉持“以患者为中心”的初心和理念，深耕实体瘤这一重要疾病领域，通过不断挖掘患者未满足的临床需求，持续夯实更多创新分子的差异化布局，为更多肿瘤患者带来高质量、可负担的新型治疗方案。
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’ PD-L1×VEGF Bispecific Antibody HLX37 Receives NMPA IND Approval for a Phase 1 Study, Advancing Next-Generation IO Combination Strategy
Shanghai, China, July 10, 2026 – Henlius (2696.HK) today announced that a Phase 1 clinical trial of HLX37, the company’s self-developed recombinant humanized anti-PD-L1 and VEGF bispecific antibody, as monotherapy and in combination with chemotherapy or HLX43, an innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumors has been approved by the China’s National Medical Products Administration (NMPA). Concurrently, a Phase 1 study evaluating HLX37 as a monotherapy for advanced/metastatic solid tumors is also ongoing.
HLX37: A Differentiated PD-L1xVEGF BsAb Strengthening the Foundation of Next-Generation Immuno-Oncology Therapy
In recent years, immune checkpoint inhibitors (ICIs), particularly PD-(L)1 inhibitors, have driven significant advancements in immuno-oncology (IO) and established themselves as the first-line standard of care across multiple solid tumor types. However, despite their growing clinical practice, PD-(L)1 inhibitor monotherapy is associated with limited objective response rates and is often limited by adaptive resistance and T-cell exhaustion, leading to disease relapse or progression.1 These challenges have spurred the exploration of next-generation IO strategies. Among the most promising approaches, PD-(L)1/VEGF bispecific antibodies, which combine the mechanisms of immune activation and anti-angiogenesis, have demonstrated clear synergistic potential. While anti-PD-(L)1 immunotherapy aims to reverse T-cell inhibition and restore antitumor activity, VEGF-driven aberrant tumor vasculature can create a hypoxic and acidic microenvironment that exacerbates T-cell exhaustion. Anti-angiogenic agents, by remodeling the tumor vascular structure, can enhance immune cell infiltration and drug delivery, thereby potentiating the efficacy of anti-PD-(L)1 therapy.2-3 This dual-targeting strategy is expected to overcome the limitations of current treatments, positioning PD-(L)1/VEGF bispecific antibodies as a potential cornerstone of next-generation IO.4
HLX37 is a novel recombinant humanized anti-PD-L1 and VEGF bispecific antibody independently developed by Henlius. Its mechanism of action integrates two therapeutic pathways: (1) blocking the PD-1/PD-L1 interaction and (2) inhibiting the an-giogenic pathway. This dual-targeting design is anticipated to generate synergistic antitumor effects and potentially mitigate the risk of drug resistance. By specifically binding to PD-L1 on tumor cells, HLX37 enables the enrichment of the anti-VEGF-functional bispecific antibody within the tumor microenvironment, achieving a superior therapeutic effect compared to the combination of anti-PD-L1 and anti-VEGF monoclonal antibodies. Preclinical studies demonstrated that HLX37 has strong antitumor activity and favorable safety profile, with enhanced tumor enrichment, indicating its broad therapeutic potential across multiple tumor types. These findings were first presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting.5
HLX43: A Potential Best-in-Class PD-L1 ADC Expanding the Boundaries of IO+ADC Combination Therapy
Meanwhile, as the frontiers of IO continue to expand—from IO monotherapy to the established "IO+Chemotherapy" standard of care, and now to the emerging "IO+ADC (antibody-drug conjugates)" paradigm—combination strategies have become central to enhancing IO clinical outcomes. Currently, PD-(L)1 inhibitor plus chemotherapy is recognized as a standard first-line regimen across multiple tumor types.6-7 Building upon this foundation, multiple large-scale clinical studies have further demonstrated that, in non-small cell lung cancer (NSCLC) and gastrointestinal tumors, PD-(L)1xVEGF bispecific antibodies combined with chemotherapy yield significant survival benefits over PD-(L)1 inhibitor plus chemotherapy. Furthermore, given the remarkable clinical efficacy demonstrated by ADCs in oncology,8 the mechanistic rationale for combining PD-(L)1xVEGF bispecific antibodies with ADCs is well-supported, with early clinical data preliminarily validating the synergistic potential of such combinations.9-10
HLX43 is a potentially best-in-class and broad-spectrum PD-L1-targeting ADC that features a dual mechanism of action combining immune checkpoint blockade with payload-mediated cytotoxicity. To date, Preliminary clinical data has indicated a manageable safety profile and encouraging efficacy in various solid tumors, with notable anti-tumor activity observed in various NSCLC patient subgroups. Henlius is currently advancing HLX43's clinical development with significant momentum, having initiated over ten clinical studies evaluating HLX43 as a monotherapy or in combination with other therapies across a broad range of solid tumors, including cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), metastatic colorectal cancer (mCRC), gastric/gastroesophageal junction (G/GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC), and breast cancer (BC), with over 1,000 patients enrolled globally to date. Beyond monotherapy, the Company is actively exploring combination strategies with other proprietary molecules, including the innovative anti-EGFR monoclonal antibody pimurutamab (HLX07) and the anti-PD-1 monoclonal antibody serplulimab (trade name: Hetronifly in Europe), to further evaluate its potential in earlier lines of therapy and various combination settings.
Platform-Driven Synergy: Building Competitiveness in IO 2.0 through a Combination Matrix
Henlius has established an integrated antibody R&D platform covering the entire value chain from discovery to commercial manufacturing, anchored by a next-generation IO platform centered on PD-(L)1, which serves as the core engine driving sustained innovation in differentiated antibody therapeutics.
At the molecular discovery stage, the antibody R&D platform is focused on the development of function-blocking antibodies, featuring diverse antibody libraries including naïve, synthetic humanized, and immune camelid VHH libraries. This enables flexible screening of high-affinity, high-specificity nanobodies (VHH) and scFv against various targets, providing a continuous pipeline of novel candidates for the early discovery of multispecific antibodies and other innovative molecules. In parallel, building on decades of industry expertise, the Company has systematically constructed a comprehensive database for the design and functional characterization of multispecific antibodies (bispecific, trispecific, and tetraspecific antibodies) and antibody fusion proteins, significantly enhancing the efficiency and success rate of developing complex antibody molecules. On the clinical and commercial front, leveraging the efficient translational capabilities of its antibody R&D platform, Henlius has successfully secured market approval for 10 products and is advancing 19 clinical-stage assets (including innovative monoclonal antibodies, ADCs, fusion proteins, and biosimilars) with over 30 ongoing clinical trials. In CMC (chemistry, manufacturing, and controls), the Company has built a robust technical system with proven capabilities in developing complex molecules, covering the entire spectrum from discovery to commercialization. This integrated R&D capability, combined with a well-validated quality system, synergistically accelerates the translation of promising candidate molecules into high-quality clinical and commercial products.
Looking ahead, Henlius remains steadfast in its patient-centered commitment, dedicated to deepening its presence in the key therapeutic area of solid tumors. By continuously addressing unmet clinical needs, the Company will further strengthen its differentiated portfolio of innovative molecules, striving to deliver high-quality, affordable novel therapeutic options to more cancer patients worldwide.
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.
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参考文献
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(复星医药 动态宝)
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