三登国际顶刊！4年OS率达21.9%，复宏汉霖H 药 汉斯状®小细胞肺癌长期生存数据发表于JAMA Oncology

此前，ASTRUM-005研究中期分析结果于2022年9月发表于《美国医学会杂志》（JAMA）主刊，成为全球首个登上该刊的小细胞肺癌免疫治疗临床研究，2025年，该研究更新数据分析及生物标志物探索成果发表于Cancer Communications。此外，ASTRUM-005研究还先后在2022年、2024年和2025年ASCO年会上披露了关键数据，实现了学术会议与顶级期刊的协同发布。这一贯穿四年、三度登顶国际顶刊的学术历程，不仅彰显了研究数据的高度稳健性，更标志着该研究获得国际权威学术界的一致认可。

肺癌是全球发病率最高、致死率居首的恶性肿瘤，2022 年全球新发病例约 250 万，死亡病例约 180 万 ¹。小细胞肺癌（SCLC）是肺癌中侵袭性最强的亚型，占所有肺癌病例的 15%²。SCLC患者中约三分之二确诊时已处于广泛期，其5年生存率仅为7%^2,3。

ASTRUM-005研究是一项随机、双盲、国际多中心、安慰剂对照的Ⅲ期临床试验，旨在评价斯鲁利单抗联合化疗（卡铂+依托泊苷）一线治疗ES-SCLC的疗效和安全性。研究在全球6个国家共114个试验中心开展，纳入585例既往未接受过治疗的ES-SCLC患者，基于该研究，H药已在中国、英国、欧盟、新加坡、印度、瑞士、秘鲁等50个国家和地区获批用于一线治疗ES-SCLC，成为全球首个获批该适应症的抗PD-1单抗，并获得美国FDA等多国监管机构的孤儿药资格认定，填补了临床治疗空白。

截至2024年5月7日数据截止时，中位随访时间为42.4个月，长期随访数据证实斯鲁利单抗方案可带来持久的临床生存获益：

• 总生存期（OS）：斯鲁利单抗组中位OS达15.8 个月，较化疗对照组的11.1个月延长4.7个月，死亡风险降低40%（HR=0.60，95% 置信区间：0.49-0.73，P<0.001）。长期生存数据尤为亮眼，斯鲁利单抗组4年总生存率高达 21.9%，为化疗组（7.2%）的三倍以上。

• 肿瘤应答与疾病控制：斯鲁利单抗组中位无进展生存期（PFS）达5.8个月（化疗组4.3 个月，HR=0.47，P<0.001），客观缓解率（ORR）提升至 68.9%，中位缓解持续时间（DOR）6.8个月，均明显优于对照组，提示更多患者可获得深度、持久的肿瘤缓解。

• 安全性与生活质量：长期随访未发现新增安全信号，≥3级治疗相关不良事件发生率与化疗组相近（35.0% vs 29.1%）。同时，患者报告结局数据表明，斯鲁利单抗方案在延长生存期的同时，相较于化疗组，未降低患者生活质量。

H药是复宏汉霖自主研发的创新型人源化抗PD-1单抗，具有差异化的药理机制。临床前研究证明，该药物不仅具备更强的PD-1内吞作用，可减少T细胞表面PD-1受体⁴，实现快速、强效的免疫激活；还能减少PD-1对共刺激分子CD28的募集，从而更大程度保留CD28信号传导^5-7，增强下游AKT蛋白活性⁸，促进T细胞持续活化。

依托独特的机制优势，H药在肺癌和胃癌领域均取得突破，是全球首个获批用于SCLC一线治疗的抗PD-1单抗，也是全球首个且唯一*获批胃癌围术期适应症的抗PD-1单抗。截至目前，H药已在全球范围内**获批鳞状非小细胞肺癌（sqNSCLC）、ES-SCLC、食管鳞癌（ESCC）和非鳞状非小细胞肺癌（nsqNSCLC）的一线治疗以及胃癌围术期治疗。H药的相关关键性临床研究成果接连获得国际顶级学术期刊的权威认可，充分彰显了其循证医学证据的引领价值。肺癌领域，除ASTRUM-005研究外，针对sqNSCLC一线治疗的ASTRUM-004研究与nsqNSCLC一线治疗的ASTRUM-002研究，分别获发表于Cancer Cell和《柳叶刀·呼吸病学》（The Lancet Respiratory Medicine）；消化道肿瘤领域，针对胃癌围术期治疗的ASTRUM-006研究与一线治疗ESCC的ASTRUM-007研究，则分别荣登《柳叶刀》（The Lancet）主刊和《自然-医学》（Nature Medicine），进一步巩固了H药在多个瘤种治疗中的学术地位。

与此同时，复宏汉霖围绕肺癌和消化道肿瘤等高发癌种，持续推动H药的全球临床开发。肺癌领域，H药已全面覆盖晚期肺癌一线治疗，除已获批的适应症，H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心Ⅲ期临床试验已完成患者入组；在美国和日本同步开展的ES-SCLC桥接试验亦已完成全部入组。消化道肿瘤领域，H药联合贝伐珠单抗及化疗一线治疗转移性结直肠癌（mCRC）的Ⅲ期国际多中心临床研究（ASTRUM-015）已完成全球入组，有望填补免疫治疗在MSS mCRC领域的临床空白。

此外，H药的国际化征途正持续破局，商业化版图加速扩容。目前，该产品已在中国、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，覆盖全球近半数人口。复宏汉霖携手Accord、Abbott等全球合作伙伴，持续推进H药的海外商业化进程。自2025年2月首次在欧盟获批以来，H药已在16个欧盟国家上市，并在奥地利、丹麦、德国、爱尔兰、意大利、西班牙、瑞典等10个国家纳入医保或公共支付体系，进入当地主流医疗保障体系，全球可及性不断提升。

*截至2026年6月22日

**不同国家或地区的获批适应症请以当地药品监管部门发布的公告为准

Henlius’ Serplulimab Marks Third Publication in a Leading International Journal, with Small Cell Lung Cancer Long-Term Survival Data Published in JAMA Oncology and a 4-Year OS Rate of 21.9%

Recently, the end-of-study analysis results from ASTRUM-005, a study of Henlius’ self-developed anti-PD-1 monoclonal antibody(mAb) HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly^®) in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), were published in the internationally renowned oncology journal JAMA Oncology (impact factor: 23.9). The publication also reported patient-reported outcomes (PROs) data for the first time. The final analysis confirmed that serplulimab delivers durable and clinically meaningful survival benefits for patients with ES-SCLC, accompanied by a contemporaneous editor’s note that highly recognized the durable clinical benefit this study brings to patients with ES-SCLC. The relevant long-term follow-up data were first presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, and their publication in a top-tier journal now provides high-level evidence to inform global clinical practice, further reinforcing its leading position in the field of immunotherapy for small cell lung cancer.

In September 2022, the interim analysis of ASTRUM-005 was published in JAMA, becoming the first clinical immunotherapy study in small cell lung cancer worldwide to appear in the journal. In 2025, updated data analyses and biomarker exploration results were published in Cancer Communications. In addition, key data from ASTRUM-005 were presented at the ASCO Annual Meetings in 2022, 2024, and 2025, achieving coordinated dissemination through both major academic conferences and top-tier journals. This four-year academic journey, with three appearances in leading international journals, not only highlights the robustness of the study data but also reflects broad recognition from the global academic community.

4-Year OS Rate Reaches 21.9%, Further Validating Durable Long-Term Benefit

Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide, with approximately 2.5 million new cases and 1.8 million deaths reported globally in 2022.¹ Small cell lung cancer (SCLC), the most aggressive subtype of lung cancer, accounts for around 15% of all lung cancer cases.² Approximately two-thirds of patients with SCLC are diagnosed at the extensive stage, and the 5-year survival rate remains only 7%.^2,3

ASTRUM-005 is a randomized, double-blind, international multicenter, placebo-controlled Phase 3 clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with chemotherapy (carboplatin plus etoposide) as first-line treatment for ES-SCLC. Conducted across 114 investigational sites in 6 countries, the study enrolled 585 previously untreated patients with ES-SCLC. Based on the ASTRUM-005 results, serplulimab has been approved in 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, for the first-line treatment of ES-SCLC, making it the world’s first anti-PD-1 mAb approved for this indication. It has also received orphan drug designation from the U.S. FDA and other regulatory authorities, addressing a significant unmet clinical need.

As of the data cutoff date of May 7, 2024, with a median follow-up of 42.4 months, the long-term follow-up results demonstrated durable survival benefits with the serplulimab-based regimen:

• Overall Survival (OS): Median OS reached 15.8 months in the serplulimab group, representing an extension of 4.7 months versus 11.1 months in the chemotherapy control group, with a 40% reduction in the risk of death (HR=0.60, 95% CI: 0.49–0.73, P<0.001). Long-term survival outcomes were particularly notable, with a 4-year OS rate of 21.9% in the serplulimab group—more than triple that of the chemotherapy group (7.2%).

• Tumor Response and Disease Control: Median progression-free survival (PFS) was 5.8 months in the serplulimab group versus 4.3 months in the chemotherapy group (HR=0.47, P<0.001). The objective response rate (ORR) improved to 68.9%, and median duration of response (DOR) was 6.8 months, both markedly superior to the control arm, suggesting that more patients achieved deeper and more durable tumor responses.

• Safety and Quality of Life: No new safety signals were identified during long-term follow-up. The incidence of grade ≥3 treatment-related adverse events was comparable between the serplulimab and chemotherapy groups (35.0% vs 29.1%). Meanwhile, PRO data showed that the serplulimab regimen prolonged survival without compromising patients’ quality of life.

As an innovative anti-PD-1 mAb independently developed by Henlius, serplulimab is distinguished by a differentiated mechanism. Preclinical studies have proven that serplulimab not only induces stronger PD-1 internalization—reducing PD-1 receptor presence on T cells for rapid and potent immune activation⁴—but also minimizes PD-1-mediated recruitment of the co-stimulatory molecule CD28, thereby preserving CD28 signaling,^5-7 enhancing downstream AKT activity,⁸ and promoting sustained T-cell activation.

Leveraging its unique mechanistic advantages, serplulimab has achieved breakthroughs in both lung cancer and gastric cancer. It is the world’s first anti-PD-1 mAb approved for first-line treatment of SCLC, and also the first and only* anti-PD-1 mAb approved for the perioperative treatment of gastric cancer. To date, serplulimab has been approved globally** for first-line treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC), as well as perioperative treatment of gastric cancer. Key clinical studies of serplulimab have been successively published in leading international medical journals, highlighting the strong value and leadership of its evidence base. In lung cancer, beyond the ASTRUM-005 study, results from the ASTRUM-004 study in first-line sqNSCLC and the ASTRUM-002 study in first-line nsqNSCLC were published in Cancer Cell and The Lancet Respiratory Medicine, respectively. In gastrointestinal cancers, the ASTRUM-006 study in perioperative gastric cancer and the ASTRUM-007 study in first-line ESCC were published in The Lancet and Nature Medicine, respectively, further reinforcing the academic influence of serplulimab across multiple tumor types.

At the same time, Henlius continues to advance the global clinical development of serplulimab across high-incidence cancers, including lung cancer and gastrointestinal malignancies. In lung cancer, serplulimab now covers the full spectrum of first-line treatment for advanced lung cancer. Beyond already approved indications, patient enrollment has been completed in an international multicenter Phase 3 trial evaluating serplulimab in combination with chemotherapy and concurrent radiotherapy as first-line treatment for limited-stage SCLC (LS-SCLC). In addition, bridging studies for ES-SCLC being conducted in parallel in the United States and Japan have also completed enrollment. In gastrointestinal cancer, global enrollment has been completed in the international multicenter Phase 3 study ASTRUM-015, which is evaluating serplulimab in combination with bevacizumab and chemotherapy as first-line treatment for metastatic colorectal cancer (mCRC), with the potential to address an unmet need for immunotherapy in patients with MSS mCRC.

In addition, serplulimab continues to make breakthroughs internationally, with its commercial footprint expanding rapidly. Up to date, it has been approved in 50 countries and regions including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the global population. Henlius, together with its regional partners including Accord and Abbott, has continued to advance market access and commercialisation efforts for serplulimab in overseas markets. Since receiving its first approval in the European Union in February 2025, to date, serplulimab has been commercially launched in 16 European countries and has been included in reimbursement or public healthcare coverage systems in 10 countries, including Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, thereby gaining access to mainstream healthcare systems in these markets.

*As of June 22, 2026

**Approved indications may vary by country or region. Please refer to the prescribing information and approvals issued by the relevant local regulatory authorities.

媒体：PR@Henlius.com

投资者：IR@Henlius.com