广谱联用新方案，PD-L1 ADC HLX43联用H药斯鲁利单抗及HLX07的临床试验申请获批

2026年1月27日，复宏汉霖（2696.HK）宣布，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）及其自研的重组抗EGFR单克隆抗体HLX07用于晚期实体瘤治疗的临床试验申请获中国国家药品监督管理局（NMPA）批准。

近年来，免疫检查点抑制剂（以抗PD-1/L1抗体为代表）已成为癌症治疗的重要手段之一。然而，部分患者对该疗法无响应，或者从单药中获益有限¹，由此推动了联合治疗策略的发展，其中免疫联合化疗已成为多种肿瘤的一线标准治疗方案。随着新型疗法的涌现，免疫联合用药的选择日益丰富。抗体偶联药物（ADC）在肿瘤治疗中已展现出卓越的临床疗效，其与免疫疗法的组合（IO+ADC）不仅能产生协同抗肿瘤效应，更有望提升应答率并克服耐药，成为最具潜力的免疫联用方向²。目前，IO+ADC的治疗方案已在尿路上皮癌中率先获批³，在胃癌、非小细胞肺癌、乳腺癌、头颈鳞癌等实体瘤中，多项IO+ADC的联合疗法也显示出突出治疗潜力，有望成为未来肿瘤免疫治疗的主线疗法^4-5。

EGFR（表皮生长因子受体）过表达被认为是肺癌、结直肠癌、头颈鳞癌等恶性肿瘤发展的重要驱动机制，成为实体瘤治疗中已验证的关键靶点之一⁶。尽管EGFR靶向疗法包括西妥昔单抗等已显著改变了多种癌症的治疗格局，但EGFR的异常激活可导致免疫逃避，创造免疫抑制的微环境，单一药物靶向治疗效果有限。已有研究表明，西妥昔单抗与伊立替康（一类拓扑异构酶抑制剂）的联合疗法在转移性结直肠癌的治疗中展现出显著优势，目前已获批用于该病的一线及后线治疗^7-8。此外，“抗PD-1/L1单抗+抗EGFR抗体”、“抗PD-1/L1单抗+抗EGFR抗体+化疗”的联合用药方案也在头颈鳞癌、皮肤鳞癌、结直肠癌等多种实体瘤的后线、辅助及新辅助治疗领域进行探索^9-12。

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。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，同时是全球首个一线治疗小细胞肺癌的抗PD-1单抗。凭借其差异化的机制，H药在多种实体瘤的治疗中展现出独特优势。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。此前，公司已启动HLX43与斯鲁利单抗以及HLX43与HLX07联合用于晚期实体瘤治疗的临床探索。基于H药汉斯状^®（斯鲁利单抗）、PD-L1 ADC HXL43展现出的广谱治疗潜力，抗EGFR单抗HLX07联合斯鲁利单抗±化疗积极的临床数据，公司计划在两药联合治疗方案（HLX43联合斯鲁利单抗、HLX43联合HLX07）的基础上，进一步拓展至三药联合方案，有望通过双免疫阻断和精准靶向的协同机制，最大化公司多款核心创新分子的治疗潜力。

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。

【参考文献】

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Martin Reck, Jyoti D. Patel, et al. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study, Journal of Thoracic Oncology, 2025,
Tolaney S M , Azambuja E D , et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study.[J].Journal of Clinical Oncology, 2025, 43(17_suppl):LBA109-LBA109.
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关于HLX43

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。临床前研究显示，HLX43在PD-1/PD-L1单抗耐药的非小细胞肺癌、宫颈癌、食管鳞癌等多个瘤种中展现出治疗潜力，且耐受性良好。其I期临床数据于2025美国临床肿瘤学会（ASCO）年会及2025 世界肺癌大会（WCLC）上先后发布，在NSCLC等实体瘤中展现出“高效、低毒”的显著疗效，尤其在NSCLC的治疗上，HLX43展现了全人群覆盖的潜力。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，验证了其在实体瘤领域的广泛治疗潜力。

关于H药汉斯状^®

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。自2022年上市以来，H药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) 适应症，在中国、英国、德国、新加坡、印度等40多个国家获批上市，覆盖全球近半数人口。凭借其差异化的机制，H药在多种实体瘤的治疗中展现出独特优势，在肺癌和胃癌领域皆斩获全球突破性进展，其关键性临床研究结果发表于JAMA、Nature Medicine、Cancer Cell和British Journal of Cancer等顶级学术期刊，并获得美国、欧盟、瑞士、韩国、墨西哥孤儿药资格认定。

关于HLX07

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。目前，公司围绕肺鳞癌、皮肤鳞癌、鼻咽癌、食管鳞癌等多个实体瘤适应症，积极开展HLX07单药或联合H药汉斯状^®（斯鲁利单抗）的II期临床探索。根据2025 WCLC最新数据发布，HLX07联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者一线治疗中展现出显著的抗肿瘤活性和持久疗效，在中位随访18.6个月时实现了约70%的客观缓解率（ORR）和超过90%的疾病控制率（DCR），高剂量组的中位无进展生存期（PFS）更达到17.4个月，表明抗EGFR单抗与PD-1/L1抑制剂的联用，不仅阻断EGFR生长信号，更同步激活免疫应答，极具联合协同治疗潜力。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，6个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状^®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状^®（斯鲁利单抗，欧洲商品名：Hetronifly^®）、自主研发的中美欧三地获批单抗生物类似药汉曲优^®（曲妥珠单抗，美国商品名：HERCESSI^™，欧洲商品名：Zercepac^®）、国内首个生物类似药汉利康^®（利妥昔单抗）、地舒单抗生物类似药Bildyos^®和Bilprevda^®，以及帕妥珠单抗POHERDY^®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius Receives an IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Anti-PD-1 mAb Serplulimab and Novel Anti-EGFR mAb HLX07

Shanghai, China, January 27, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for a clinical trial of HLX43, the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced solid tumors.

Immune checkpoint inhibitors represented by anti-PD-1/PD-L1 monoclonal antibodies have become a cornerstone of cancer treatment. However, there are still many patients who do not respond to or derive limited benefit from monotherapy¹, which has fueled the development of combination strategies. Among these, immunochemotherapy has become a first-line standard of care for multiple tumor types. As novel therapies expand the combination immunotherapy landscape, antibody-drug conjugates (ADCs) have emerged as a highly effective option. Their combination with immunotherapy (IO) may create synergy for more potent and durable responses while overcoming resistance, thereby addressing critical unmet clinical needs². A major breakthrough has been the approval of an IO-ADC combination as first-line treatment for advanced urothelial cancer³. This success has accelerated exploration in other solid tumors like gastric cancer (GC), non-small cell lung cancer (NSCLC), breast cancer (BC), and head and neck squamous cell carcinoma (HNSCC), positioning it as a key next-generation approach^4-5.

EGFR (Epidermal Growth Factor Receptor) overexpression is considered a crucial driving mechanism in the development of various malignant tumors, including lung cancer, colorectal cancer (CRC), and HNSCC, establishing it as one of the validated key targets in solid tumor treatment⁶. Although EGFR-targeted therapies, such as cetuximab, have significantly altered the treatment landscape for many cancers, abnormal EGFR activation can lead to immune evasion and create an immunosuppressive microenvironment, resulting in limited efficacy for single agent targeted therapy. Previous studies have shown that combination of cetuximab and irinotecan (a topoisomerase inhibitor) demonstrates potent efficacy in metastatic colorectal cancer, and is now approved for both first-line and later-line treatment of the disease^7-8. Furthermore, strategies of "anti-PD-1/L1 mAb plus anti-EGFR mAb" and "anti-PD-1/L1 mAb plus anti-EGFR mAb plus chemotherapy" are widely explored in the later-line, adjuvant, and neoadjuvant settings for various solid tumors, including HNSCC, cutaneous squamous cell carcinoma (CSCC) and CRC^9-12.

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. 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. Serplulimab (HANSIZHUANG) is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, and the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). It has shown unique advantages in various solid tumors via its differentiated mechanism. HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. The company has initiated clinical trials of HLX43 in combination with serplulimab, as well as HLX43 combined with HLX07, for the treatment of advanced solid tumors. Leveraging the broad therapeutic potential of serplulimab and the PD-L1 ADC HLX43, along with encouraging clinical data for the anti-EGFR mAb HLX07 plus serplulimab with or without chemotherapy, the company plans to expand from two ongoing dual combination therapies—HLX43 plus serplulimab and HLX43 plus HLX07—into a triple-combination regimen. This strategy aims to maximize the clinical value of its core innovative products by harnessing the synergistic effects of dual immune checkpoint blockade and precision targeting.

By strategically prioritizing solid tumor domain as a core therapeutic area, Henlius continues to uphold its patient-centric mission, accelerating differentiated innovation to address unmet medical needs and delivering high-quality, affordable therapies to tumor patients worldwide.

About HLX43

HLX43 is a potential best-in-class pan-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data has shown that, HLX43 has promising anti-tumor activity and a favorable tolerability profile in NSCLC, cervical cancer (CC), esophageal squamous cell carcinoma (ESCC) and other tumor types that were PD-1/L1 mAb-resistant. The results from the phase 1 clinical trial of HLX43 were released at the 2025 ASCO Annual Meeting and 2025 WCLC, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. 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.

About Serplulimab

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), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC). It has been approved in over 40 countries and regions including China, the U.K., Germany, Singapore, and India, covering nearly half of the global population and accelerating global accessibility. Serplulimab demonstrates unique advantages in various solid tumors via its differentiated mechanism, especially achieving groundbreaking progress in both lung and gastric cancers. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. It has also received orphan drug designations granted by the US FDA, the European Commission, Swissmedic, Korea MFDS and Mexico COFEPRIS.

About HLX07

HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with serplulimab for the treatment of solid tumors including sqNSCLC, CSCC, nasopharyngeal carcinoma (NPC) and ESCC. According to the updated results in 2025 WCLC, the combination of HLX07 with serplulimab and chemotherapy demonstrated remarkable antitumor activity and durable efficacy as first-line treatment for patients with EGFR overexpression sqNSCLC. At a median follow-up of 18.6 months, both dose groups achieved an objective response rate (ORR) of around 70% and a disease control rate (DCR) of over 90%. The median progression-free survival (PFS) reached 17.4 months in the high-dose group. This indicates that the combination of HLX07 and serplulimab blocks EGFR signaling while activating immune responses, supporting strong therapeutic synergy.

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. To date, 10 products have been approved for marketing across multiple countries and regions, and 6 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 HANSIZHUANG (serplulimab, trade name: Hetronifly^® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI^™ in the U.S., Zercepac^® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos^® and Bilprevda^®, and pertuzumab Poherdy^®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

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/.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com