摘要：2025年10月17日至21日，2025年欧洲肿瘤内科学会年会（ESMO 2025）将在德国柏林举行。本次大会上，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）肺癌和消化道肿瘤领域多项研究最新结果入选。其中，
转自：复星医药
2025年10月17日至21日，2025年欧洲肿瘤内科学会年会（ESMO 2025）将在德国柏林举行。本次大会上，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）肺癌和消化道肿瘤领域多项研究最新结果入选。其中，斯鲁利单抗联合化疗一线治疗晚期非鳞状非小细胞肺癌的III期临床（ASTRUM-002）研究的最终分析结果入选本次大会的LBA（Late-breaking Abstract），并将以口头汇报的形式在本次大会首次发布。此外，H药多项研究入选大会简单口头报告（Mini Oral）和壁报展示等多个环节，彰显在肺癌和消化道肿瘤领域的创新实力和学术影响力。
H药 汉斯状®为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市，覆盖全球近半数人口。聚焦肺癌和消化道肿瘤等高发实体肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，截至目前，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（nsqNSCLC），并在美国和日本同步开展ES-SCLC的桥接试验。
在肺癌领域，H药目前已全面覆盖肺癌一线治疗，除了已获批的sqNSCLC、ES-SCLC和nsqNSCLC三项肺癌适应症，同时正在全球范围内积极推动一项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。H药联合化疗一线治疗晚期非鳞状非小细胞肺癌的III期临床（ASTRUM-002）的重要成果连续获得国际顶级学术会议的认可。继期中数据于2025年WCLC大会以口头报告的形式首次发布后，在本届ESMO大会上，其最终分析结果成功入选LBA，并将由牵头主要研究者、中国医学科学院肿瘤医院石远凯教授以口头汇报的形式首次发布截止日期2025年8月7日的研究数据。此外，一项探索斯鲁利单抗联合化疗诱导治疗不可切除IIIB-IIIC期NSCLC的IIT研究结果也入选大会Mini Oral。
在消化道肿瘤领域，公司持续深化H药的临床探索，除已获批的ESCC，亦积极推进一项H药联合化疗用于新辅助/辅助治疗胃癌III期临床研究，有望为胃癌围手术期患者带来更多治疗选择。H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心III期临床研究（ASTRUM-015）也于全球多个国家同步推进中。本次大会上，探索H药用于新辅助治疗局晚期胃癌和直肠癌以及一线治疗晚期胰腺癌的多项IIT研究也入选壁报展示环节。
入选本次ESMO 2025大会的相关研究如下：
ASTRUM-002研究
论文题目：斯鲁利单抗联合化疗（联合或不联合HLX04）用于晚期非鳞状非小细胞肺癌的一线治疗的最终分析：ASTRUM-002 III期研究
入选形式：LBA
场次：Mini oral session 2 : NSCLC metastatic
编号：LBA71
牵头主要研究者：石远凯 中国医学科学院肿瘤医院
展示时间：2025年10月20日上午10:15-10:20（柏林时间）
论文题目：斯鲁利单抗联合化疗诱导治疗后手术与放疗治疗不可切除的IIIB-IIIC期非小细胞肺癌：一项随机对照、开放标签的II期临床研究
入选形式：Mini Oral
场次：Mini oral session 2: Non-metastatic NSCLC
编号：1818MO
牵头主要研究者：张鹏 上海市肺科医院
展示时间：2025年10月20日下午15:25-15:30（柏林时间）
论文题目：全程新辅助化疗联合PD-1 抑制剂治疗局部进展期胃或食管胃结合部腺癌患者的II期临床研究
入选形式：壁报展示
编号：2862
牵头主要研究者：李元方 中山大学肿瘤防治中心
展示时间：2025年10月19日（柏林时间）
论文题目：一项探索斯鲁利单抗联合CAPEOX+塞来昔布新辅助治疗局部进展期中低位直肠癌有效性和安全性的单臂临床研究：ASTRUM-REC01
入选形式：壁报展示
编号：6754
牵头主要研究者：丁克峰 浙江大学医学院附属第二医院
展示时间：2025年10月19日（柏林时间）
论文题目：晚期胰腺癌一线使用斯鲁利单抗联合贝伐珠单抗及白蛋白结合型紫杉醇/吉西他滨，随后使用mFOLFOX方案：一项 II 期临床试验
入选形式：壁报展示
编号：2230
牵头主要研究者：应杰儿 浙江省肿瘤医院
展示时间：2025年10月19日（柏林时间）
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9款产品，4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）、以及地舒单抗生物类似药Bildyos®和Bilprevda®。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。
Results of Serplulimab in Lung and Gastrointestinal Cancer Selected for ESMO 2025: Late-Breaking Abstract and Oral Presentations
From October 17 to 21, 2025, the European Society for Medical Oncology (ESMO) Annual Meeting will be held in Berlin, Germany. At this conference, the latest results from multiple studies in lung cancer and gastrointestinal tumours of Henlius' self-developed innovative anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, Hetronifly® in Europe) have been selected. Notably, the final analysis of the Phase III ASTRUM-002 trial—evaluating serplulimab plus chemotherapy as first-line treatment for advanced non-squamous non-small cell lung cancer (nsqNSCLC)—has been chosen as a Late-Breaking Abstract (LBA) and the final analysis results will be orally presented for the first time at the conference. In addition, several studies of serplulimab were selected for mini oral and poster presentations, underscoring its innovative strength and academic impact in the fields.
HANSIZHUANG is the world’s first approved anti-PD-1 monoclonal antibody (mAb) for first-line treatment of small cell lung cancer (SCLC). It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, covering nearly half of the global population. Focusing on lung and gastrointestinal cancers, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. To date, serplulimab has been approved for the treatment of squamous NSCLC (sqNSCLC), extensive-stage SCLC (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsqNSCLC). Bridging studies for ES-SCLC are currently underway in the United States and Japan.
In lung cancer, serplulimab has covered the full range of first-line treatment. Beyond its three approved indications (sqNSCLC, ES-SCLC, nsqNSCLC), Henlius is conducting a global, multicenter Phase 3 trial of serplulimab plus chemotherapy and radiotherapy for first-line treatment of limited-stage SCLC (LS-SCLC). The pivotal Phase 3 ASTRUM-002 trial has garnered recognition at leading international congresses: following its initial oral presentation at WCLC 2025, its final analysis has now been selected as an LBA for ESMO 2025 and will be orally presented by its leading PI Professor Shi Yuankai (Cancer Hospital, Chinese Academy of Medical Sciences), featuring data up to August 7, 2025. Additionally, an IIT study evaluating serplulimab plus chemotherapy for induction therapy in unresectable stage IIIB-IIIC NSCLC has been selected for a Mini Oral session.
In the field of gastrointestinal cancers, the company continues to deepen its clinical exploration of serplulimab. In addition to the approved indication for ESCC, the company is actively advancing a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, expected to provide more therapeutic options for perioperative gastric cancer patients. An international, multicenter Phase 3 trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy as first-line therapy for metastatic colorectal cancer (mCRC) is also actively enrolling patients globally. At ESMO 2025, multiple IITs investigating serplulimab for neoadjuvant therapy in locally advanced gastric & rectal cancer, as well as first-line therapy for advanced pancreatic cancer have been selected for poster presentations.
The studies selected for ESMO 2025 are as follows:
Title: Final Analysis of First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer: the ASTRUM-002 Phase 3 Study
Form: LBA
Session: Mini oral session 2 : NSCLC metastatic
Number: LBA71
Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy Of Medical Sciences
Time: Oct 20 2025, 10:15 - 10:20 (Berlin local time)
Title: Surgery versus radiotherapy after induction therapy with serplulimab combined with chemotherapy for unresectable stage IIIB-IIIC non-small cell lung cancer: a randomized controlled, open-label, phase 2 trial
Form: Mini Oral
Session: Mini oral session 2: Non-metastatic NSCLC
Number: 1818MO
Leading PI: Peng Zhang, Shanghai Pulmonary Hospital
Time: Oct 20 2025, 15:25-15:30(Berlin local time)
Title: Total neoadjuvant chemotherapy plus PD-1 antibody in locally advanced gastric or gastro-esophageal junction adenocarcinoma: A proof-of-concept, phase 2 trial
Form: Poster
Abstract Number: 2862
Leading PI: Yuanfang Li, Sun Yat-sen University Cancer Center
Time: Oct 19 2025 (Berlin local time)
Title: Serplulimab Combined with CapeOX and Celecoxib as Neoadjuvant Therapy for Proficient Mismatch Repair Locally Advanced Mid-to-Low Rectal Cancer (SCAR)
Form: poster
Abstract Number: 6754
Leading PI: Kefeng Ding, The Second Affiliated Hospital of Zhejiang University School of Medicine
Time: Oct 19 (Berlin local time)
Title: First-line Serplulimab and Bevacizumab Combined with Nab-Paclitaxel/Gemcitabine Followed by mFOLFOX in Advanced Pancreatic Cancer: A Phase II Trial
Form: poster
Abstract Number: 2230
Leading PI: Jieer Ying, Zhejiang Cancer Hospital,
Time: Oct 19 (Berlin local time)
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, 9 products have been approved for marketing across multiple countries and regions, and 4 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, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.
来源：新浪财经
