全球研发|星空体育子公司复宏汉霖HLX43联合汉斯状®用于NSCLC新辅助治疗II期临床试验获澳大利亚临床批准_研发动态_研发动态_研发创新_星空体育(中国)官方网站

2026-06-17

全球研发|星空体育子公司复宏汉霖HLX43联合汉斯状^?用于NSCLC新辅助治疗II期临床试验获澳大利亚临床批准

2026年6月16日，星空体育子公司复宏汉霖（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^?（斯鲁利单抗注射液）用于非小细胞肺癌（NSCLC）新辅助治疗的II期临床试验（HLX43-NSCLC203），已获得相关人类研究伦理委员会批准，并通过澳大利亚药品管理局（Therapeutic Goods Administration，TGA）的临床试验备案。公司将全面推动该研究在多区域开展，为HLX43与免疫检查点抑制剂联合应用于早期肺癌治疗场景提供更多临床依据。

聚焦NSCLC围术期治疗需求，

探索创新联合治疗方案

据GLOBOCAN数据显示，肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例，占所有癌症新发病例的12.4%¹。非小细胞肺癌（NSCLC）是最常见的肺癌类型，约占全部肺癌病例的85%。对于早、中期NSCLC患者，手术仍是主要治疗手段之一。然而，即使获得了根治性切除机会，超过半数的II-III期NSCLC患者术后仍面临局部复发或远处转移风险²。

近年来，以PD-1/PD-L1抑制剂为代表的免疫检查点抑制剂在NSCLC围手术期治疗领域取得重要进展，多项III期临床研究显示^3-5，新辅助免疫治疗单药或联合化疗可改善可切除II-III期NSCLC患者的病理缓解水平，并延长无事件生存期及总生存期，已成为II-III期NSCLC围手术期治疗新标准。

在此基础上，已有临床研究显示ADC与免疫检查点抑制剂联用具有协同增效作用^⁶。基于免疫治疗在NSCLC围手术期治疗中的临床价值，以及ADC在肿瘤精准治疗中的发展潜力，HLX43联合H药汉斯状^{^?}有望探索可切除NSCLC新辅助治疗的新策略。

基于既往积极数据，

HLX43联合免疫治疗向新辅助场景推进

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。根据2026年美国临床肿瘤学会（ASCO）年会公布的HLX43单药治疗NSCLC研究数据，HLX43在经治NSCLC患者中显示令人鼓舞的抗肿瘤活性，且不受组织学和PD-L1表达限制；在安全性与耐受性方面，在覆盖不同给药剂量、不同NSCLC亚型及不同治疗背景患者的205例分析人群中，HLX43整体也呈现出一致且可控的安全性特征。除HLX43-NSCLC203研究外，HLX43一项针对晚期NSCLC的国际多中心II期临床研究（HLX43-NSCLC201）已在中欧美日澳等地启动；同时，HLX43用于晚期鳞状非小细胞肺癌（sqNSCLC）的II/III期国际多中心临床研究（HLX43-NSCLC302）正于中美日等多国开展，其III期研究阶段有望成为HLX43首个、同时也是其在非小细胞肺癌领域的关键注册临床研究。

H药汉斯状^?是复宏汉霖自主研发的抗PD-1单克隆抗体，已在全球50个市场获批上市，在肺癌领域全面覆盖广泛期小细胞肺癌（ES-SCLC）、鳞状非小细胞肺癌（sqNSCLC）及非鳞状非小细胞肺癌（nsqNSCLC）等关键适应症的一线标准治疗，其一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床研究亦已完成全球入组，为复宏汉霖持续探索肺癌免疫联合治疗奠定了基础。

复宏汉霖深度布局肺癌治疗领域，已形成覆盖多种组织学类型、多个治疗阶段、兼具免疫、靶向、抗血管与抗体偶联药物（ADC）等多机制的综合产品矩阵。除HLX43和H药汉斯状^?外，公司还围绕贝伐珠单抗汉贝泰^?、抗EGFR单抗pimurutamab以及DLL3 x DLL3 x CD3 x CD28四特异性T细胞衔接器HLX3901、c-MET x EGFR双抗ADC HLX48等早期创新管线持续推进肺癌领域研发。

未来，复宏汉霖将持续深化肺癌领域创新布局，通过多元化的产品组合和全球化的临床开发，为患者带来更多突破性治疗方案，创造更大的临床价值和社会效益。

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。其临床数据于2025美国临床肿瘤学会（ASCO）年会、2025 世界肺癌大会（WCLC）、2026 ASCO年会上先后发布，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，公司积极探索其在多种实体瘤中的治疗潜力，包括食管鳞癌、宫颈癌、乳腺癌、胃癌/胃食管交界部（G/GEJ）癌、头颈鳞癌等。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索ADC与其他疗法的协同抗肿瘤疗效。HLX43不仅展现出克服PD-1/L1免疫疗法不响应或耐药问题的临床潜力，并对化疗、TKI治疗失败的患者都具有潜在疗效，有望为更多晚期/转移性实体瘤患者带来新的治疗选择。

关于H药汉斯状^{^?}

H药汉斯状^{^?}为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液，欧洲商品名：Hetronifly^{^?}），是全球首个获批一线治疗小细胞肺癌（SCLC）和首个获批胃癌围术期适应症的抗PD-1单抗，目前已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等50个国家和地区获批上市。

2022年3月，H药正式在中国获批上市，目前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）、非鳞状非小细胞肺癌（nsqNSCLC）及胃癌（GC）。随着胃癌适应症获批，H药成为全球首个在胃癌围术期以免疫单药替代术后辅助化疗的治疗方案。

在研进展方面，复宏汉霖正全面推进H药的全球临床开发计划，目前已在全球开展超过10项肿瘤免疫联合治疗研究，累计入组患者超过5,700例，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一，并在美国和日本同步开展ES-SCLC的桥接试验。在结直肠癌领域，III期国际多中心临床研究ASTRUM-015已完成患者入组。该研究评估了H药联合贝伐珠单抗及化疗用于转移性结直肠癌（mCRC）一线治疗的疗效与安全性。同时，其II期临床的最新数据进一步凸显了H药在带来高疾病负担的恶性消化道肿瘤领域持续拓展临床价值的潜力⁷。

H药的多项关键性临床研究结果分别发表于知名期刊《柳叶刀》（The Lancet）、《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）和British Journal of Cancer。此外，H药还荣获《CSCO胃癌诊疗指南》、《CSCO 小细胞肺癌诊疗指南》、《CSCO 非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO 免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA等多国监管机构的孤儿药资格认定。

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。

Exploring Earlier-Stage Treatment Potential: Henlius’ Phase 2 Clinical Trial of HLX43 in Combination with Serplulimab for Neoadjuvant Treatment of NSCLC Approved for Clinical Trial in Australia

Shanghai, China, June 16, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the phase 2 clinical trial (HLX43-NSCLC203) of HLX43 for injection, the company’s innovative programmed death-ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC), in combination with serplulimab for the neoadjuvant treatment of non-small cell lung cancer (NSCLC), has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The approval to conduct clinical trial in Australia is expected to further support the multi-regional development of the study and provide additional clinical evidence for the combination of HLX43 and?immune checkpoint inhibitors (ICIs) in earlier-stage lung cancer treatment.

Addressing Perioperative Treatment Needs in NSCLC and Exploring an Innovative Combination Regimen

According to GLOBOCAN, lung cancer is the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide. In 2022, there were more than 2.48 million new lung cancer cases globally, accounting for 12.4% of all lung cancer new cases.1?NSCLC is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. For patients with early- and middle-stage NSCLC, surgery remains one of the primary treatment approaches. Despite the opportunity for curative resection, more than half of those with stage II–III NSCLC still face risks of local recurrence or distant metastasis after surgery.2

In recent years, ICIs and targeted therapies have significantly advanced the treatment strategies for NSCLC. Multiple phase 3 clinical studies have shown that neoadjuvant immunotherapy, with or without chemotherapy, can improve pathological response rates and prolong event-free survival and overall survival in patients with resectable stage II–III NSCLC.3-5?These advances have established perioperative immunotherapy as a new standard of care for stage II–III NSCLC.?

Building on this progress, clinical studies have also suggested that ADCs in combination with immune checkpoint inhibitors may have synergistic anti-tumor effects.6?Based on the clinical value of immunotherapy in perioperative NSCLC treatment as well as the potential of ADCs in precision oncology, HLX43 in combination with serplulimab is expected to explore a new neoadjuvant strategy for resectable NSCLC.

Building on Prior Positive Data, HLX43 Advances Toward Neoadjuvant Treatment ExplorationHLX43 is a potentially best-in-class and broad-spectrum antitumour ADC that combines immune checkpoint blockade with the cytotoxic activity of a topoisomerase inhibitor payload. 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. According to results from a study of HLX43 monotherapy in NSCLC presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, HLX43 demonstrated encouraging anti-tumor activity in previously treated NSCLC patients, regardless of histology or PD-L1 expression. In terms of safety and tolerability, across the 205-patient analysis population encompassing multiple dose levels, NSCLC subtypes, and treatment backgrounds, HLX43 demonstrated a consistent and manageable safety profile.

In addition to HLX43-NSCLC203, an international multi-center Phase 2 clinical study of HLX43 in advanced NSCLC (HLX43-NSCLC201) has been initiated in China, Europe, the United States, Japan, Australia and other regions. Meanwhile, the international multi-center phase 2/3 clinical study, HLX43-NSCLC302, of HLX43 in advanced squamous NSCLC (sqNSCLC) is currently underway in China, the United States, Japan and other countries. The phase 3 stage of this study is expected to become HLX43’s first pivotal registrational clinical study, as well as a key registrational study for HLX43 in NSCLC.

Serplulimab (trade name: Hetronifly^??in Europe) is an anti-PD-1 monoclonal antibody (mAb) independently developed by Henlius. It has been approved in 50 markets worldwide and has established comprehensive coverage in lung cancer, including first-line treatment for key indications such as extensive-stage small cell lung cancer (ES-SCLC), squamous non-small cell lung cancer (sqNSCLC) and non-squamous non-small cell lung cancer (nsqNSCLC). Its international multi-center phase 3 clinical study as first-line treatment for limited-stage small cell lung cancer (LS-SCLC) has also completed global enrollment, laying a solid foundation for Henlius to continue exploring immunotherapy-based combination regimens in lung cancer.

Henlius has established a deep and comprehensive presence in the lung cancer therapeutic landscape, building a diversified product portfolio that spans multiple histological subtypes, treatment stages, and therapeutic mechanisms, including immunotherapy, targeted therapy, anti-angiogenic agents, and antibody–drug conjugates (ADCs). In addition to HLX43 and serplulimab, the company is continuing to advance lung cancer R&D around bevacizumab HLX04, anti-EGFR mAb pimurutamab, as well as early-stage innovative assets including HLX3901, a DLL3 x DLL3 x CD3 x CD28 tetraspecific T-cell engager for small cell lung cancer, and HLX48, a c-MET x EGFR bispecific ADC for NSCLC.

Looking ahead, Henlius will continue to deepen its innovation-driven strategy in lung cancer, leveraging a diversified portfolio and global clinical development capabilities to deliver more breakthrough therapies, generate greater clinical value, and create meaningful societal impact for 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. Preliminary clinical results of HLX43 were presented at the 2025 ASCO Annual Meeting, 2025 WCLC, and the 2026 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. In addition, Henlius is actively exploring the therapeutic potential of HLX43 across multiple solid tumors, including esophageal squamous cell carcinoma (ESCC), cervical cancer, breast cancer, gastric/gastroesophageal junction (G/GEJ) cancer and head and neck squamous cell carcinoma. Beyond monotherapy, clinical trials investigating HLX43 in combination with other agents are ongoing to further explore the synergistic anti-tumor efficacy of ADCs with complementary therapies. HLX43 demonstrates the clinical potential to overcome primary or acquired resistance to PD-1/L1 immunotherapies and offers potential efficacy for patients who have failed chemotherapy or TKI treatments, bringing hope for a new generation of treatments to patients with advanced or metastatic solid tumors.

About Serplulimab

Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name: Hetronifly^{^?}?in Europe). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and for perioperative gastric cancer. Up to date, it has been approved in 50 countries and regions including China, the U.K., EU, Singapore, India, Switzerland, and Peru.

In March 2022, serplulimab was officially approved ?in China and is currently indicated for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC). With the approval of the gastric cancer indication, serplulimab has become the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy.

Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,700 patients enrolled, with over 30% of patients enrolled in two pivotal international studies being Caucasian, making it one of the anti-PD-1 mAbs with the most extensive international clinical data. Bridging studies for ES-SCLC are being conducted in the United States and Japan.

In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.

Three pivotal clinical studies of serplulimab have been published in leading journals including?The Lancet, The?Journal of the American Medical Association (JAMA),?Nature Medicine, and the?British Journal of Cancer. In addition, serplulimab has been included in several authoritative clinical guidelines, such as the CSCO Guidelines for SCLC, NSCLC, ESCC, GC, Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy in Esophageal Cancer, providing important references for oncology clinical practice. Internationally, serplulimab for the treatment of SCLC has been granted Orphan Drug Designations (ODDs) by regulatory authorities of multiples countries, including the U.S. FDA.

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 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/ and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

参考文献

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