ELCC 2026 | 复宏汉霖抗PD-1单抗H药肺癌领域研究数据发布

2026年欧洲肺癌大会（ELCC 2026）于当地时间3月25日至28日在丹麦哥本哈根举行。在本次大会上，复宏汉霖创新型抗PD-1单抗H药汉斯状^®在肺癌领域的多项研究结果以壁报形式正式发布，覆盖局限期小细胞肺癌（LS-SCLC）巩固治疗、非小细胞肺癌（NSCLC）新辅助治疗以及鳞状非小细胞肺癌（sqNSCLC）和广泛期小细胞肺癌（ES-SCLC）真实世界研究等多个方向，研究数据进一步印证了H药在肺癌治疗中的疗效价值与广泛潜力。

H药是全球首个一线治疗小细胞肺癌的抗PD-1单抗，也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*，在肺癌和胃癌领域皆斩获全球突破性进展。聚焦肺癌与消化道肿瘤，H药已获批用于治疗sqNSCLC、ES-SCLC、食管鳞癌（ESCC）和非鳞状非小细胞肺癌（nsqNSCLC) 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，并在德国、意大利、西班牙等7个欧盟成员国完成医保准入。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，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。

在肺癌治疗领域，除已获批适应症外，H药联合化疗同步放疗一线治疗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，计划于2026年递交上市注册申请（NDA）。在欧盟，H药治疗鳞状与非鳞状非小细胞肺癌的适应症有望于2026年获批；此外，H药在美国和日本同步开展针对广泛期小细胞肺癌的桥接试验，其中美国的头对头桥接试验已完成患者入组，计划于2026年向FDA递交生物制品许可申请。

本次ELCC大会上公布的系列研究结果为H药在肺癌治疗领域的应用提供了新的循证支持。其中，H药用于局限期小细胞肺癌巩固治疗的研究取得积极结果，为同步放化疗后使用斯鲁利单抗进行巩固治疗提供了有力证据。在非小细胞肺癌方面，斯鲁利单抗联合化疗新辅助治疗Ⅱ-ⅢB期非小细胞肺癌的研究数据显示，该方案有望提升患者的病理缓解率。此外，真实世界研究结果进一步证实，H药一线治疗肺鳞癌具有良好的疗效与耐受性，联合胸部放疗用于广泛期小细胞肺癌也展现出一定的治疗潜力。

此次ELCC大会上发布的研究数据结果如下：

#小细胞肺癌

局限期小细胞肺癌同步大分割放化疗后使用斯鲁利单抗巩固治疗

试验设计：

这项多中心、单臂、II 期试验评估了在四个周期的卡铂/顺铂联合依托泊苷同步大分割放疗（45Gy/3Gy/15F）后，未进展的局限期小细胞肺癌（LS-SCLC）患者使用斯鲁利单抗巩固治疗的疗效和安全性。以一项前瞻性 III 期试验（NCT02688036）中仅接受大分割同步放化疗（Hypo-cCRT）的历史队列患者的生存结果作为对照，采用逆概率加权（IPTW）分析来平衡基线特征，对比不同治疗模式下生存结果。

结果：

截至 2025 年 11 月 25 日，中位随访时间为 29.4 个月，对 55 例使用斯鲁利单抗巩固治疗的患者进行了分析。自开始使用斯鲁利单抗计算，中位无进展生存期（PFS）为 27.5 个月（95%CI：15.7 - 未达到），1 年和 2 年的 PFS 率分别为 63.6%（95%CI：52.1 - 77.7%）和 54.0%（95%CI：42.2 - 69.1%）。中位总生存期（OS）未达到，1 年和 2 年的 OS 率分别为 92.7%（95%CI：86.1 - 99.9%）和 78.9%（95%CI：68.4 - 90.9%）。经过倾向评分加权（IPTW）分析，与仅接受大分割同步放化疗(Hypo-cCRT）的队列相比，斯鲁利单抗巩固治疗组显著提高PFS（风险比 = 0.60，95%CI 0.41 - 0.90，P = 0.014）和OS（风险比 = 0.48，95%CI 0.27 - 0.85，P = 0.011）。在大分割同步放化疗（hypo-cCRT）治疗后，初始ORR为 100.0%（6 例CR，49 例PR）。在使用斯鲁利单抗巩固治疗后，缓解程度进一步加深，总体客观缓解率（ORR）仍为 100.0%，但CR率从cCRT阶段的10.9%进一步提高29.1%（16 例CR，39 例PR）。未观察到 5 级毒性反应。3 - 4 级免疫相关不良事件的发生率为 21.8%（n = 12）。3 - 4 级放射性肺炎和放射性食管炎的发生率分别为 7.3%（n = 4）和 1.8%（n = 1）。

结论：

ASTRUM-LC01 试验表明，在同步放化疗后使用斯鲁利单抗进行巩固治疗，能够显著提高患者的生存获益，且安全性可控。与对照组相比，其显著延长的总生存期支持将斯鲁利单抗作为同步放化疗后巩固治疗的潜在策略，也支持其在随机对照试验中进一步验证。

化疗联合免疫治疗ES-SCLC后巩固性胸部放疗的真实世界研究

试验设计：

该研究回顾了2018年至2024年间PD-1/PD-L1抑制剂联合铂类-依托泊苷一线治疗后实现疾病控制的ES-SCLC患者，所有患者根据是否接受巩固性胸部放（cTRT）分为两组，对其疗效和安全性进行分析。主要终点是PFS，次要终点包括OS、DpR和安全性。

结果：

本研究共纳入91例患者，cTRT组患者的ECOG PS评分更好和肿瘤负荷更小。接受cTRT的患者中位PFS和中位OS显著更长（P<0.001）。考虑到回顾性研究中的患者选择偏倚进行加权分析，尽管加权后生存差异减弱，但在数值上仍然有利于cTRT组，中位PFS为13.77vs10.07个月，中位OS为31.87vs17.27个月。 Cox分析显示c TRT的应用与较长的PFS（HR0.54;P=0.036）和OS（HR0.45;P=0.033）相关。 DpR分析显示cTRT组的额外肿瘤缓解率更高（74.4％对46.2％;P=0.007）。整体安全性良好，大多数放疗相关事件为1-2级（33.3％），没有发生5级不良事件（AEs）。

结论：

在真实世界的队列中，化疗联合免疫后进行cTRT产生更明显的缩瘤效果和改善生存结果。本研究为回顾性研究，后续的前瞻性随机试验是必要的，以进一步确定cTRT在免疫治疗时代的最佳作用。

#非小细胞肺癌

斯鲁利单抗联合化疗新辅助治疗 Ⅱ-ⅢB 期非小细胞肺癌（NSCLC）的前瞻性研究

试验设计：

本项前瞻性、单臂研究纳入经组织学证实、可切除或潜在可切除的 Ⅱ-ⅢB 期非小细胞肺癌成年患者。患者接受3 周期斯鲁利单抗联合含铂双药化疗后，可切除的患者接受根治性手术，不可切除者则接受放化疗。主要研究终点为主要病理缓解（MPR）；次要终点包括病理完全缓解（pCR）、客观缓解率（ORR）、疾病控制率（DCR）及不良事件（AE）。

结果：

本研究共纳入 82 例患者（中位年龄 65.5 岁），均接受至少 1 周期新辅助治疗。其中鳞癌 68 例（82.9%），ⅢA/ⅢB 期患者 45 例（54.9%）。ORR 为 91.5%（75/82；95% CI：83.2%-96.5%），DCR 为 93.9%（77/82；95% CI：86.3%-98.0%）。术后 T 分期或 N 分期降期率分别为 82.6% 和 55.1%。在 69 例（84.1%）接受根治性手术的患者中：MPR 率为 73.9%，pCR 率为 53.6%，R0 切除率为 98.6%。亚组分析：

鳞癌患者 pCR 率为 58.2%，腺癌为 38.5%；N2 期患者 pCR 率为 73.3%，N0-1 期为 48.2%，ⅡA/ⅡB 期与 ⅢA/ⅢB 期患者病理缓解率相近（MPR：77.4% vs 71.2%；pCR：51.6% vs 55.3%）；7例患者接受放化疗，44 例接受辅助治疗。生存数据尚未成熟。3-4 级不良事件发生率为 23.2%（n=19），其中 3-4 级免疫相关不良事件发生率为 2.4%（n=2）。3-4 级手术相关并发症发生率为 4.9%（n=4）。

结论：

斯鲁利单抗联合化疗新辅助治疗在 Ⅱ-ⅢB 期局部晚期非小细胞肺癌中获得显著的病理缓解，且安全性可控。

斯鲁利单抗一线治疗晚期鳞状非小细胞肺癌的真实世界研究：ASTRUM-004R研究的生存数据更新

试验设计：

ASTRUM-004R是一项在中国14个中心进行的回顾性真实世界研究。纳入晚期sqNSCLC患者，接受一线斯鲁利单抗联合铂类治疗后进行斯鲁利单抗维持治疗，最长可达2年或直到疾病进展或无法耐受的毒性。本次分析报告了更新的生存结果，包括无进展生存期（PFS）、总生存期（OS）以及关键患者亚组的PFS分析。

结果：

截至2025年10月31日，共纳入132名患者，中位年龄为69岁，94名（71.2%）患者年龄≥65岁，26名患者（19.7%）的ECOG PS评分为2，62名患者（47.0%）为IV期疾病，67名患者（50.8%）接受了一线维持治疗。在中位随访18.0个月时，中位PFS为14.8个月（95%CI：11.9 - 19.6），6个月PFS率为78.5%（95%CI：71.5 - 86.2%）。接受白蛋白紫杉醇治疗的患者与接受紫杉醇治疗的患者的中位PFS获益相当（17.5 vs. 15.2个月，P = 0.677），两组之间的疗效无显著差异。III期患者的中位PFS优于IV期患者（20.4 vs. 11.9个月，P = 0.009）。中位OS为29.7个月（95%CI：29.7 - NR），12个月OS率为90.1%（95%CI：84.7 - 95.9%）。更新数据分析显示出持久的抗肿瘤活性，客观缓解率为66.7%（95%CI：57.9 - 74.6%），疾病控制率为95.5%（95%CI：90.4 - 98.3%）。任何级别不良事件（AEs）的发病率为36.4%， ≥3级免疫相关不良事件在6.8%的患者中报告。

结论：

更新的结果证实，斯鲁利单抗联合铂类一线治疗在鳞状非小细胞肺癌（sqNSCLC）中提供了显著的生存获益，并具有可控的安全性，与ASTRUM-004试验的结果一致。长期生存获益需要通过进一步随访验证。

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个国家和地区获批上市，其中7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、4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的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；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。

Latest Results from Studies of Henlius’Serplulimab in Lung Cancer Released at ELCC 2026

The European Lung Cancer Congress 2026 (ELCC 2026) is being held from March 25 to 28 in Copenhagen, Denmark. At the congress, Henlius announced several research findings for its innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly^®) via poster presentations. The data covers a broad clinical spectrum, including consolidation therapy for limited-stage small cell lung cancer (LS-SCLC), neoadjuvant therapy for non-small cell lung cancer (NSCLC), and real-world studies (RWS) in squamous NSCLC (sqNSCLC) and extensive-stage SCLC (ES-SCLC). These results further validate the therapeutic value and clinical potential of serplulimab in lung cancer management.

Serplulimab is the world’s first anti-PD-1 mAb approved for the first-line treatment of SCLC and the first and only anti-PD-1 mAb to achieve success in a Phase 3 registrational study for perioperative gastric cancer*, marking global breakthroughs in both lung and gastrointestinal cancers. To date, serplulimab has been approved for indications including sqNSCLC, ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsqNSCLC). It is currently marketed in over 40 countries—including China, the UK, Germany, Singapore, and India—covering nearly half of the global population. Furthermore, It has also been included in public reimbursement systems in seven EU countries, including Germany, Italy, and Spain.

Leveraging its differentiated mechanism, serplulimab has demonstrated unique advantages across multiple solid tumors. 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.

In the lung cancer field, beyond its currently approved indications, an international multicenter phase 3 clinical trial of serplulimab combined with chemoradiotherapy for first-line treatment of LS-SCLC has completed the subject enrollment. A New Drug Application (NDA) is planned for submission in 2026. In the EU, approvals for serplulimab in sqNSCLC and nsqNSCLC are expected in 2026. Additionally, bridging trials for ES-SCLC are underway in the U.S. and Japan; notably, the head-to-head bridging trial in the U.S. has completed enrollment, with a Biologics License Application (BLA) submission to the FDA targeted for 2026.

The data presented at ELCC 2026 provide new evidence-based support for serplulimab’s clinical application in lung cancer. Key highlights include positive results for serplulimab as consolidation therapy in LS-SCLC following concurrent chemoradiotherapy (cCRT). In NSCLC, data from a neoadjuvant study (serplulimab plus chemotherapy for Stage II-IIIB NSCLC) suggests the regimen may significantly improve pathological response rates. Furthermore, real-world data reaffirmed serplulimab’s robust efficacy and tolerability in first-line sqNSCLC and its potential when combined with thoracic radiotherapy for ES-SCLC.

The research results presented at ELCC are as follows:

SCLC

Title: Serplulimab Consolidation after Concurrent Hypofractionated Chemoradiotherapy for Limited-stage Small-cell Lung Cancer

Study design: This multicenter, single-arm, phase II trial evaluates the efficacy and safety of serplulimab consolidation in response LS-SCLC patients following four cycles of carboplatin/cisplatin plus etoposide with concurrent hypofractionated radiotherapy (45Gy/3Gy/15F). Progression-free survival (PFS), overall survival (OS), and safety were assessed. Survival outcomes of patients treated with Hypo-cCRT alone in a historical cohort derived from a prospective phase III trial (NCT02688036) served as control. Inverse probability of treatment weighting (IPTW) was performed to balance baseline characteristics.

Results: With median follow-up of 29.4 months (data cutoff: Nov 25, 2025), 55 patients in serplulimab cohort and 241 in Hypo-cCRT cohort were analyzed. The median PFS was 27.5 months (95% CI: 15.7-NR) since initiation of serplulimab, with 1- and 2-year PFS rates of 63.6% (95% CI: 52.1-77.7%) and 54.0% (95% CI: 42.2-69.1%), respectively. Median OS was not reached, with 1- and 2-year OS rates of 92.7% (95% CI: 86.1-99.9%) and 78.9% (95% CI: 68.4-90.9%). After IPTW analysis, serplulimab consolidation demonstrated a significant PFS benefit over Hypo-cCRT group (HR= 0.60, 95% CI 0.41-0.90, P=0.014). It also conferred a superior OS (HR=0.48, 95% CI 0.27-0.85, P=0.011). No grade 5 toxicity was observed. The incidence of grade 3-4 immune-related adverse events was 21.8% (n=12). Grade 3-4 radiation pneumonitis and esophagitis occurred in 7.3% (n=4) and 1.8% (n=1) of patients, respectively.

Conclusion: ASTRUM-LC01 trial demonstrated that serplulimab consolidation following Hypo-cCRT yields compelling survival benefits with a manageable safety. The significant OS improvement over control group support serplulimab after Hypo-cCRT as a potential therapeutic strategy, warranting validation in randomized controlled trials.

Title: Clinical Efficacy of Consolidative Thoracic Radiotherapy Following Chemoimmunotherapy in ES-SCLC: A Real-World Comparative Study

Study design: This retrospective study reviewed the records of ES-SCLC patients who achieved disease control after first-line PD-1/PD-L1 inhibitor combined with platinum–etoposide chemotherapy between 2018 and 2024. All patients were divided into two groups based on whether they received cTRT. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), depth of radiologic response (DpR), and safety. Inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances.

Results: A total of 91 patients were included, with the cTRT group exhibiting a more favorable ECOG performance status and lower tumor burden. Unadjusted analyses revealed that patients who received cTRT had significantly longer median PFS and median OS (P < 0.001). However, given the patient selection bias in this retrospective study, IPTW was applied to adjust for confounding. After weighting, survival differences were attenuated but remained numerically in favor of the cTRT group, with a weighted median PFS of 13.77 vs. 10.07 months, and a median OS of 31.87 vs. 17.27 months. Cox analysis showed receipt of cTRT was independently associated with prolonged both PFS (HR 0.54; P = 0.036) and OS (HR 0.45; P = 0.033). DpR analysis showed a higher rate of additional tumor shrinkage in the cTRT group (74.4% vs. 46.2%; P = 0.007). Toxicities were manageable; most radiation-related events were grade 1–2 (33.3%), and no grade 5 adverse events (AEs) occurred.

Conclusion: In this real-world cohort, cTRT following chemoimmunotherapy yielded more pronounced tumor shrinkage and exerted an independent association with improved survival outcomes. Prospective randomized trials are warranted to further define the optimal role of cTRT in the immunotherapy era.

NSCLC

Title: A Prospective Study of Neoadjuvant Serplulimab Plus Chemotherapy for Stage II-IIIB Non-Small Cell Lung Cancer (NSCLC)

Study design: This prospective, single-arm study enrolled adult patients with histologically confirmed resectable or potentially resectable stage II-IIIB NSCLC. Patients received 3 cycles of neoadjuvant serplulimab plus platinum-doublet chemotherapy. Following re-assessment, eligible patients underwent curative-intent surgery, while those deemed unresectable proceeded to chemoradiotherapy. Primary endpoint was major pathologic response (MPR); secondary endpoints were pathologic complete response (pCR), objective response rate (ORR), disease control rate(DCR), and adverse events (AEs).

Results: This study enrolled 82 patients (median age, 65.5 years) and treated with at least 1 cycle of neoadjuvant therapy. 68 patients (82.9%) were squamous cell carcinoma, and 45 (54.9%) had stage IIIA/IIIB disease. The ORR and DCR were 91.5% (75/82; 95% CI: 83.2-96.5%) and 93.9% (77/82; 95% CI: 86.3-98.0%), respectively. Postoperative stage T or N downstaging was achieved in 82.6% and 55.1% of patients. Among 69 patients (84.1%) who received curative-intent surgery, MPR, pCR and R0 resection rates were 73.9%, 53.6% and 98.6%, respectively. The pCR rates were 58.2% and 38.5% for patients with squamous cell carcinoma and adenocarcinoma, respectively, and 73.3% and 48.2% for those with N2 and N0-1 stage disease. Comparable pathological response rates were found between IIA/IIB and IIIA/IIIB disease (MPR: 77.4% vs 71.2%; pCR: 51.6% vs 55.3%). Seven patients received chemoradiotherapy, and 44 received adjuvant therapy. Survival data remain immature. Grade 3-4 AEs occurred in 23.2% of patients (n=19), with 2.4% (n=2) reporting grade 3-4 immune-related AEs. Four patients (4.9%) reported grade 3-4 surgery-related complications

Conclusion: Neoadjuvant serplulimab plus chemotherapy yielded substantial pathologic responses with a manageable safety in stage II-IIIB locally advanced NSCLC.

Title: First-line Serplulimab for Advanced Squamous Non-small Cell Lung Cancer: Updated Survival of the ASTRUM-004R Trial

Study design: ASTRUM-004R is a retrospective, real-world study conducted at 14 centers in China. Patients with advanced sqNSCLC received first-line serplulimab plus platinum-based therapy, followed by serplulimab maintenance for up to 2 years or until disease progression or intolerable toxicity. The updated analysis reports comprehensive survival outcomes, including progression-free survival (PFS), overall survival (OS), and PFS analyses across key patient subgroups.

Results: As of October 31, 2025, 132 patients had been enrolled, with a median age of 69 years. Among them, 94 (71.2%) were aged ≥ 65 years, 26 (19.7%) had an ECOG performance status of 2, and 62 (47.0%) had stage IV disease. Sixty-seven patients (50.8%) underwent first-line maintenance therapy. At a median follow-up of 18.0 months, the median PFS was 14.8 months (95% CI: 11.9 - 19.6), with a 6-month PFS rate of 78.5% (95% CI: 71.5 - 86.2%). The median PFS benefit was comparable between patients receiving nab-paclitaxel and those receiving paclitaxel (17.5 vs. 15.2 months, P = 0.677), suggesting no significant difference in efficacy between the two groups. Stage III patients had a superior median PFS compared with stage IV patients (20.4 vs. 11.9 months, P = 0.009). The median OS was 29.7 months (95% CI: 29.7 - NR), with a 12-month OS rate of 90.1% (95% CI: 84.7 - 95.9%). The updated analysis showed durable antitumor activity, with an objective response rate of 66.7% (95% CI: 57.9 - 74.6%) and a disease control rate of 95.5% (95% CI: 90.4 - 98.3%). The incidence of any grade adverse events (AEs) was 36.4%, with grade ≥3 immune-related AEs reported in 6.8% of patients.

Conclusion: The updated results confirm that first-line serplulimab plus platinum-based therapy provides a significant survival benefit with a manageable safety profile in sqNSCLC, consistent with findings from the ASTRUM-004 trial. The long-term survival benefit requires further validation with additional follow-up.

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 60 countries and regions worldwide, including seven 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 four 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 has been approved in more than 40 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 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/.

注释

截至2026年3月28日

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媒体：PR@Henlius.com

投资者：IR@Henlius.com