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资讯 2026年7月31日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自研的创新型程序性死亡-配体1（PD-L1）抗体偶联药物（ADC）注射用HLX43联合贝伐珠单抗及联合/不联合化疗用于晚期/转移性实体瘤治疗的临床研究获中国国家药品监督管理局（NMPA）批准。
近年来，多项临床研究结果均证实了 PD-(L)1 抑制剂与抗VEGF 药物（如贝伐珠单抗）存在协同抗肿瘤效应，即 PD-(L)1 抑制剂可通过阻断 PD-(L)1 恢复免疫系统的抗肿瘤作用，抗 VEGF 药物可通过阻断 VEGF 的免疫抑制作用并促进 T 细胞在肿瘤组织中的浸润从而提高前者疗效1。目前，NCCN 指南将“阿替利珠单抗+贝伐珠单抗+含铂双药”作为驱动基因阴性的晚期非鳞状 NSCLC 一线治疗的 1 类推荐。同时，传统拓扑异构酶抑制剂和贝伐珠单抗联合用药的疗效已在临床研究中得到充分验证2-3。现阶段，伊立替康联合贝伐珠单抗方案已被NCCN、CSCO 等国内外权威诊疗指南一致推荐为mCRC 一线、二线标准治疗方案。随着ADC在肿瘤治疗中展现出卓越的临床疗效4，多款不同靶点 的ADC 单药联合贝伐珠单抗在实体瘤（含结直肠癌）中展现出良好抗肿瘤活性，且整体安全可控、未出现非预期叠加毒性5-7。基于此，为本研究的联合用药设计提供了临床依据与实践支撑。
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。
贝伐珠单抗是全球首个获批的抗血管生成药物，通过抑制肿瘤新生血管形成，在结直肠癌、肺癌等多种实体瘤治疗中奠定了治疗基石地位8。汉贝泰?是由复宏汉霖自主开发的贝伐珠单抗生物类似药，于2021年11月正式获得国家药品监督管理局（NMPA）批准上市。目前，该产品已覆盖多项实体瘤适应症，包括1）转移性结直肠癌，2）晚期、转移性或复发性非小细胞肺癌，3）复发性胶质母细胞瘤，4）肝细胞癌，5）上皮性卵巢癌、输卵管癌或原发性腹膜癌以及6）宫颈癌。此外，汉贝泰?还联合汉斯状?（抗PD-1单抗）针对多类肿瘤开展肿瘤免疫联合疗法研究。
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，已在全球超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 Announces IND Approval for Its Innovative PD-L1 ADC HLX43 in Combination with Bevacizumab ± Chemotherapy
Shanghai, China, July 31, 2026 – Henlius (2696.HK) today announced that the investigational new drug (IND) application for HLX43, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab with or without chemotherapy, for the treatment of advanced/metastatic solid tumors has been approved by China’s National Medical Products Administration (NMPA).
In recent years, multiple clinical studies have confirmed the synergistic antitumor effect of PD-(L)1 inhibitors in combination with anti-VEGF agents such as bevacizumab. Specifically, PD-(L)1 inhibitors restore antitumor immunity by blocking the PD-(L)1 pathway, while anti-VEGF agents may enhance the efficacy of the former by reversing VEGF-mediated immunosuppression and promoting T-cell infiltration into tumor tissues.1 Currently, the NCCN Guidelines recommend atezolizumab plus bevacizumab and platinum-based doublet chemotherapy as a Category 1 preferred regimen for the first-line treatment of advanced non-squamous NSCLC with negative driver genes. Meanwhile, the efficacy of conventional topoisomerase inhibitors combined with bevacizumab has been well validated in clinical studies.2-3 To date, the irinotecan plus bevacizumab regimen has been uniformly recommended by authoritative domestic and international guidelines including NCCN and CSCO as a standard first- and second-line treatment for metastatic colorectal cancer (mCRC). With ADC therapies demonstrating compelling clinical efficacy in oncology,4 several ADC monotherapies targeting different antigens, when combined with bevacizumab, have shown promising antitumor activity in solid tumors including colorectal cancer, with a generally manageable safety profile and no unexpected additive toxicities observed.5?7 These findings provide a clinical rationale and practical support for further development and application of ADC in combination with antiangiogenic agents.
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.
Bevacizumab is the first globally approved anti-angiogenic therapy. By inhibiting tumor neovascularization, it has been established as a backbone treatment across multiple solid tumors, including colorectal and lung cancer.8 HLX04, a bevacizumab biosimilar independently developed by the company, was approved by the NMPA in November 2021. It is indicated for metastatic colorectal cancer (mCRC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), recurrent glioblastoma, cervical cancer, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It is also being proposed for combination with serplulimab (PD-1) for immuno-oncology combination therapies to treat various tumors.
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.
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/.
参考文献
References
1. Socinski et al. IMpower 150: overall survival analysis of a randomized phase III study of atezolizumab + chemotherapy ± Bevacizumab vs chemotherapy + Bevacizumab in 1L nonsquamous NSCLC. ASCO 2018.
2. Hurwitz H, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer J. New England Journal of Medicine, 2004, 350(23): 2335-2342.
3. Bennouna J, Borg C, Delord JP, et al. Bevacizumab combined with chemotherapy in the second-line treatment of metastatic colorectal cancer: results from the phase II BEVACOLOR study J. Clinical Colorectal Cancer, 2012, 11(1): 38-44.
4. Eleonora. Nicolò, et al. Combining antibody-drug conjugates with immunotherapy in solid tumors: current landscape and future perspectives. Cancer treatment reviews 106(2022):102395.
5. Wei Q, Li P, Yang T, et al. The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors. J Hematol Oncol. 2024;17(1):1. Published 2024 Jan 4.
6. Wang Z, Wu Y, Yu Y, et al. 23P SHR-A2009, a HER3-targeted ADC, plus bevacizumab Bev for pretreated EGFR-mutated non-squamous EGFRm nsq NSCLC: A phase Ib/II study. ESMO Open, 11.
7. M. Cecchini, M. Cruz-Correa, S-W. Han, et al. 731MO Telisotuzumab adizutecan ABBV-400; Temab-A in combination with bevacizumab Bev vs standard of care SOC in patients pts with 3L+ colorectal cancer CRC: Dose expansion results of a phase I study. Annals of Oncology 2025.
8. Ferrara N, Hillan KJ, Gerber HP, Novotny W. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nature Reviews Drug Discovery. 2004;3(5):391-400.
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