Pimurutamab(Shanghai Henlius Biotech, Inc.)

太平洋时间2025年8月13日，2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）官网公布了本届大会入选研究摘要的详细信息，复宏汉霖三款肺癌领域核心创新型产品PD-L1 ADC HLX43、抗EGFR单抗HLX07和抗PD-1单抗H药 汉斯状®的10项肺癌领域研究入选大会口头报告、壁报导览、壁报展示等多个专场，其中包括4项口头报告，2项壁报导览，覆盖非鳞状/鳞状非小细胞肺癌（nsNSCLC/sqNSCLC）及广泛期小细胞肺癌（ES-SCLC）的一线治疗，同时，也探索了免疫联合疗法在脑转移患者、肺癌围术期患者等广泛人群中的治疗潜力。 据GLOBOCAN最新数据显示，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，占癌症新发病例的12.4%[1]。肺癌分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中约85%的肺癌类型为NSCLC。进一步划分，NSCLC又可为鳞状细胞癌（约30%）、肺腺癌（约50%）以及其他癌种。复宏汉霖在肺癌治疗领域持续深耕，从H药引领小细胞肺癌免疫治疗，到HLX43、HLX07等多元管线覆盖非小细胞肺癌多个分子特征，公司已逐步构建差异化、全人群覆盖的产品矩阵。 HLX43是全球首个进入临床II期阶段的PD-L1的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂（CPI）治疗并失败的后线耐药NSCLC患者中，持续表现出高应答率，在特定亚组如EGFR野生型nsNSCLC人群中展现了更为优异的疗效，ORR达47.4%，同时延续了良好的安全性。HLX07是公司自主开发的改良型靶向EGFR的人源化单抗，其联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者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，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。H药为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，迄今已在近40个国家和地区获批上市，覆盖全球近半数人口。在肺癌领域，H药已获批联合化疗用于一线治疗驱动基因阴性的鳞状非小细胞肺癌（sqNSCLC）、非鳞状非小细胞肺癌（nsNSCLC）以及广泛期小细胞肺癌（ES-SCLC）。 重磅口头报告，印证NSCLC疗效 本次大会上，由中国医学科学院肿瘤医院石远凯教授担任牵头主要研究者的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）研究，将以口头汇报的形式首次发布，mPFS显著延长5.4个月，脑转移人群获益明确。同时，多项探索H药免疫联合疗法的IIT研究结果也入选大会简短口头报告（Mini Oral）、壁报导览和壁报展示环节，印证了H药在nsNSCLC脑转移患者、EGFR-TKI耐药和非小肺癌围术期患者中的疗效与安全性，展现在更广泛人群中的治疗潜力。 ASTRUM-002研究是一项三臂、随机、双盲、多中心III期研究，患有局部进展期或转移性非鳞状非小细胞肺癌、不携带EGFR致敏突变和ALK/ROS重排、且无系统性治疗史的患者，按1:1:1比例随机分配接受斯鲁利单抗联合HLX04（贝伐珠单抗）及化疗（卡铂-培美曲塞）、斯鲁利单抗联合化疗或化疗。研究结果表明，斯鲁利单抗联合化疗对比化疗一线治疗晚期非鳞状非小细胞肺癌（NSCLC），中位无进展生存期（mPFS）显著延长（11.0个月 vs. 5.6个月；分层HR=0.55，95%置信区间[CI]：0.43-0.69，P < 0.0001），达到预设的优效标准，且具有良好的安全性，未观察到新的安全性信号。在脑转移患者亚组中，斯鲁利单抗联合化疗组的中位PFS达8.1个月，较对照组延长4.0个月，降低疾病进展或死亡风险49%（HR=0.51, 95%CI：0.30-0.87，P=0.0115）。 一项斯鲁利单抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究。研究共纳入40例未经治疗的伴有脑转移的非鳞状非小细胞肺癌患者，接受斯鲁利单抗联合贝伐珠单抗以及化疗（培美曲塞和卡铂）的一线治疗。中位随访13.3个月，中位颅内无进展生存期（iPFS）为13.1个月，颅内肿瘤客观缓解率（ORR）为84.6%，颅外ORR为64.1%，显示出强大的抗肿瘤活性。研究结果显示，斯鲁利单抗联合贝伐珠单抗和化疗一线治疗伴有脑转移的非鳞状非小细胞肺癌患者表现出有前景的颅内抗肿瘤有效性和可控的安全性。 EGFR高表达肺癌，潜力优势治疗选择 在全球非小细胞肺癌（NSCLC）患者中，EGFR高表达的比例约为40%–89%（取决于病理分型、种族等因素），意味着每年有数百万新发患者属于这一人群[2-4]。尤其是在sqNSCLC患者中，高达89%表现为EGFR高表达[2-3]。复宏汉霖亦积极推进一项创新型抗EGFR单抗HLX07联合斯鲁利单抗的创新疗法用于一线治疗EGFR高表达的sqNSCLC的临床II期研究，以满足该领域的临床未尽之需。这项研究的最新临床数据结果入选本次WCLC大会的壁报展示环节。 HLX10HLX07-sqNSCLC-201研究是一项随机、多中心的二期研究，包括4个部分，评估了HLX07（不同剂量）、斯鲁利单抗和化疗的多种组合。 第3部分评估了三药组合的初步有效性，EGFR高表达（H评分≥150）且无既往系统治疗的患者被随机分为1:1两组，接受静脉注射HLX07 800 mg或1000 mg，联合斯鲁利单抗和化疗。在中位随访18.6个月时，两个剂量组均实现了约七成的客观缓解率（ORR），且中位总生存期（mOS）和持续缓解时间（mDOR）均未达到显示出疗效持久且有进一步改善的潜力，且安全性良好。尤其值得注意的是，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。研究结果显示，HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。 肺癌一线全覆盖，ES-SCLC广获益 复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗。在小细胞肺癌领域，基于国际多中心III期临床ASTRUM-005研究，H药已于中国、英国、德国、新加坡、印度等全球近40个国家和地区获批用于一线治疗广泛期小细胞肺癌（ES-SCLC），该研究结束分析结果已于2025年美国临床肿瘤学会（ASCO）大会上发布，4年OS率达到21.9%。 针对ES-SCLC，H药于全国范围内开展的中国ES-SCLC领域样本量最大的真实世界研究（ASTRUM-005R）最新结果已于2025年欧洲肺癌大会（ELCC）上发布，研究结果显示，中位rwPFS为8.2个月，中位OS达到17.2个月，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充了有力证据。在本届WCLC大会上，该研究中针对PS评分≥2的ES-SCLC患者亚组研究分析数据，以及一项评估在ECOG PS≥2 的ES-SCLC患者人群中的荟萃分析等研究结果将进行发布，展现了免疫联合疗法对于ES-SCLC患者人群的广泛获益。 目前，复宏汉霖正在加速推进H药治疗ES-SCLC的全球开发进程，其中日本的桥接临床试验已完成首例患者入组。同时，公司正在开展一项国际多中心III期临床试验，评估H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的疗效，进一步拓展其在SCLC治疗领域的全球布局。 更多研究完整数据与亮点，敬请关注 WCLC 2025！ 参考文献 [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. [2] Prabhakar CN. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res. 2015;4(2):110-118. doi:10.3978/j.issn.2218-6751.2015.01.01 [3] Karlsen E-A, Kahler S, Tefay J, Joseph SR, Simpson F. Epidermal Growth Factor Receptor Expression and Resistance Patterns to Targeted Therapy in Non-Small Cell Lung Cancer: A Review. Cells. 2021; 10(5):1206. https://doi-org.libproxy1.nus.edu.sg/10.3390/cells10051206 [4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. 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，已有6款产品在中国获批上市，4款产品在国际获批上市，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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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。 Ten studies on Henlius' innovative products to be showcased at WCLC 2025, Including Three Oral Presentations On August 13, 2025 (Pacific Time), the World Conference on Lung Cancer (WCLC) 2025 has officially unveiled the list of accepted abstracts. Ten studies on Henlius' innovative PD-L1 ADC HLX43, anti-EGFR mAb HLX07 and anti–PD-1 monoclonal antibody(mAb)HANSIZHUANG(serplulimab) have been selected for multiple sessions, including oral presentations, poster tours, and poster presentations. Among these, 4 will be featured as oral presentations and 2 as poster tours. The selected studies span first-line treatment for non-squamous non–small cell lung cancer (nsNSCLC), squamous non–small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). In addition, innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases. Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases [1]. Lung cancer is classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC making up approximately 85% of all cases. NSCLC can be further divided into sqNSCLC(about 30%), nsNSCLC(about 50%), and other subtypes. HLX43, a broad-spectrum anti-tumor PD-L1 ADC, is the first PD-L1 ADC progressed to phase 2 clinical trial development globally, exhibiting dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. HLX43 exhibits superior efficacy in specific subgroups, with an objective response rate (ORR) of 47.4% in EGFR wild-type non-squamous NSCLC, while maintaining a favorable safety profile. HLX07 is a novel anti-EGFR mAb developed by Henlius, which demonstrated significant anti-tumor activity and durable efficacy when combined with serplulimab and chemotherapy in patients with EGFR high-expression sqNSCLC.  At a median follow-up of 18.6 months, the high dose group  reached a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months. HANSIZHUANG is the world’s first anti–PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for marketing in nearly 40 countries and regions, covering almost half of the global population. HANSIZHUANG has been approved in combination with chemotherapy as a first-line treatment for sqNSCLC, nsNSCLC and ES-SCLC.   Spotlight Oral Presentation: Demonstrating Efficacy in NSCLC In NSCLC, At this year’s WCLC, the Phase III ASTRUM-002 study, led by Professor Yuankai Shi of the Cancer Hospital, Chinese Academy of Medical Sciences, will debut its results in an oral presentation. The study evaluates serplulimab plus chemotherapy as a first-line treatment for advanced nsNSCLC, showing a median progression-free survival (mPFS) of 11.0 months, an improvement of 5.4 months compared to chemotherapy alone, as well as clear benefit in patients with brain metastases. Additionally, multiple investigator-initiated trials (IITs) exploring serplulimab in combination immunotherapy have been selected for Mini Oral presentations, poster tours, and poster presentations. These studies further validate the efficacy and safety of serplulimab in nsNSCLC patients with brain metastases, in EGFR-TKI–resistant cases, and in the perioperative setting for non-small cell lung cancer, underscoring its potential in broader patient populations. The ASTRUM-002 study is a randomized, double-blind, multicentre phase 3 clinical study. Patients with locally advanced or metastatic nsNSCLC without EGFR sensitizing mutations or ALK/ROS rearrangements and no prior systemic therapy were randomized 1:1:1 to receive serplulimab + HLX04 + chemo, serplulimab +chemo, or chemo. The results indicated that serplulimab + chemo  versus chemo as first-line treatment of advanced nsNSCLC significantly prolonged mPFS(11.0 months vs. 5.6 months; stratified HR= 0.55, 95% CI: 0.43-0.69, P < 0.0001), meeting the prespecified superiority criteria, with good safety profile and no new safety signals were observed. In the subgroup of patients with brain metastases, the median PFS in the serplulimab + chemo group reached 8.1 months, an extension of 4.0 months compared with the chemo group, reducing the risk of disease progression or death by 49% (HR = 0.51, 95% CI: 0.30-0.87, P = 0.0115). Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer Form: Oral Session: OA05-lmmunotherapy for Special Populations Abstract Number: 1454 Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences Time: Sunday Sep 7, 2025 4:47 PM-4:57 PM (CEST) A Phase 2 trial evaluated serplulimab plus bevacizumab and chemotherapy in treatment-naïve non-squamous NSCLC with brain metastases. The study enrolled 40 nsNSCLC patients with untreated brain metastases to receive first line treatment of serplulimab combined with bevacizumab, pemetrexed, and carboplatin. The median sPFS was 13.3 months. The intracranial ORR was 84.6%, with a 64.1% extracranial ORR, demonstrating potent antitumor activity. Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting. Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN) Form: Mini Oral Session: MA10-Longer Follow Up and New IO Combinations Abstract Number: 2266 Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center Time: Sep 9,2025 1:02 PM-1:07 PM (CEST) Potential Advantageous Therapy Option for EGFR High-Expression Lung Cancer In patients with NSCLC worldwide, the prevalence of EGFR overexpression is estimated at approximately 40%–89% (depending on histological subtype, ethnicity, and other factors), representing millions of newly diagnosed patients each year [2–4]. Notably, up to 89% of patients with sqNSCLC present with EGFR overexpression [2–3]. Henlius is actively advancing a phase 2 clinical study of HLX07, a novel anti-EGFR mAb developed by Henlius, in combination with serplulimab for the first-line treatment of EGFR high expression sqNSCLC, aiming to address the significant unmet clinical need in this population. Updated data from this study have been accepted for poster presentation at this year’s World Conference on Lung Cancer (WCLC). This randomized, multicenter phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemotherapy. Part 3 explored the preliminary efficacy of the tri-combination regimen in systemic treatment-naïve patients with EGFR overexpression (H-score ≥150), who were enrolled and randomly assigned to group A (n=13) and group B (n=14). Two groups of patients received intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300mg) and chemotherapy. With a median follow-up of 18.6 months, both dose groups achieved an IRRC-assessed confirmed objective response rate (ORR) of around 70%, while the median overall survival (mOS) and median duration of response (mDOR) were not reached, indicating durable responses with the potential for further improvement, alongside a manageable safety profile. Notably, the group B achieved a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months (95% CI 8.1-NE). These results demonstrate encouraging preliminary efficacy  with a manageable safety profile of HLX07 plus serplulimab and chemotherapy as first-line treatment in patients with advanced sqNSCLC, supporting further investigation of this regimen. Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study Form: Poster Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy Abstract Number: 1467 Leading PI: Yilong Wu, Guangdong Provincial People's Hospital Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST) Full coverage of first-line lung cancer treatment, broad benefits in ES-SCLC Henlius continues to expand the layout of serplulimab in the field of lung cancer, achieving full coverage of first-line lung cancer treatment. In small cell lung cancer (SCLC), based on the international multicenter Phase III ASTRUM-005 study, serplulimab has been approved in nearly 40 countries and regions worldwide, including China, the UK, Germany, Singapore, and India, for the first-line treatment of ES-SCLC. The final analysis of this study was released at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showing a 4-year OS rate of 21.9%. For ES-SCLC, the latest results from the largest real-world study in China in this field (ASTRUM-005R) were released at the 2025 European Lung Cancer Congress (ELCC). The study showed a median rwPFS of 8.2 months and a median OS of 17.2 months, providing robust evidence to support serplulimab plus chemotherapy as a first-line treatment for ES-SCLC. At this year’s WCLC, subgroup analysis data from this study in ES-SCLC patients with a PS score ≥2, as well as results from a meta-analysis in ES-SCLC patients with ECOG PS ≥2, will be presented, demonstrating the broad benefits of immunotherapy combinations for ES-SCLC patients. Henlius continues to accelerate the global development of serplulimab for ES-SCLC, with the first patient dosed in the Janpanese bridging study. In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). For more research on data integrity and highlights, please stay tuned for WCLC 2025! 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. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看

2025年9月6日至9日，国际肺癌研究学会（IASLC）2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）将在西班牙巴塞罗那举行。此次大会上，复宏汉霖将就公司肺癌领域核心创新产品的10项中选研究进行报告，其中包括3项口头报告（oral），2项壁报导览（poster tour），涵盖PD-L1 ADC HLX43 I期临床研究的更新数据，H药 汉斯状®一线治疗晚期非鳞状非小细胞肺癌III期临床研究（首次发布），以及H药在肺癌治疗领域的广泛探索结果，成为此次入选口头报告数目最多的中国生物制药企业。此次发表的具体信息如下：PD-L1 ADC HLX43：广谱抗肿瘤 兼具IO疗效的潜在同类最优ADCHLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫治疗的复合功能，其毒素不仅能够通过靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。在2025 美国临床肿瘤学会（ASCO）年会上，HLX43的I期临床数据首次发布，展现出令人鼓舞的初步疗效和安全性，对鳞状/非鳞状非小细胞肺癌（NSCLC），有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力，且安全性良好。目前，HLX43已获得中国、美国、日本及澳大利亚药监机构的注册批准，开展一项针对晚期非小细胞肺癌（NSCLC）的国际多中心II期临床研究，并在中国境内完成首例受试者给药。此次WCLC大会上，HLX43自多款ADC分子中脱颖而出，其I期更新临床数据入选壁报导览环节（逾1500份壁报中，仅5%入选壁报导览）。HLX43-FIH101研究论文题目：抗PD-L1 ADC HLX43在晚期/转移性实体瘤中的安全性、耐受性和初步有效性：I期研究展示形式：壁报导览场次：PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic Therapy摘要编号：1459牵头主要研究者：王洁 中国医学科学院肿瘤医院展示时间：2025年9月8日下午2:31- 2:39（西班牙时间）H药 汉斯状®：全球首个获批治疗SCLC的抗PD-1单抗 肺癌一线治疗全覆盖H药 汉斯状®（通用名：斯鲁利单抗注射液）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。复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗，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）、非鳞状非小细胞肺癌（nsNSCLC）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。此外，H药治疗SCLC也已获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌（SCLC）孤儿药资格，英国创新许可与准入通道合作组织授予的创新通行证资格认定，以及韩国MFDS授予的广泛期小细胞肺癌（ES-SCLC）孤儿药资格，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。同时，公司积极推进H药与公司其他产品的协同以及与创新疗法的联合，探索免疫联合疗法在肺癌围术期患者、脑转移患者等广泛人群中的治疗潜力。HLX43-FIH101研究HLX10-002-NSCLC301研究论文题目：ASTRUM-002：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展示形式：口头报告场次：OA05-lmmunotherapy for Special Populations摘要编号：1454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9月7日下午4:46-4:56（西班牙时间）滑动查看更多H药在肺癌领域的研究信息HLX07HLX10-sqNSCLC201研究论文题目：HLX07联合斯鲁利单抗(联合或不联合化疗)用于鳞状非小细胞肺癌的一线治疗：一项II期研究展示形式：壁报场次：P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy摘要编号：1467牵头主要研究者：吴一龙 广东省人民医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：斯鲁利抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究展示形式：简短口头报告场次：MA10-Longer Follow Up and New IO Combinations摘要编号：2266牵头主要研究者：陈丽昆 中山大学肿瘤防治中心展示时间：2025年9月9日下午1:02-1:07（西班牙时间）论文题目：MRD动态监测在斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的观察性研究展示形式：简短口头报告场次：MA03 New Advances in circulating Biomarkers摘要编号：1217牵头主要研究者：马克威 吉林大学第一医院展示时间：2025年9月7日下午3:17-3:22（西班牙时间）论文题目：贝伐珠单抗联合斯鲁利单抗及化疗治疗EGFR-TKI耐药的非鳞状NSCLC患者II期研究展示形式：壁报场次：P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapy摘要编号：2217牵头主要研究者：王启鸣  河南省肿瘤医院展示时间：2025年9月7日上午10:30-12:00（西班牙时间）论文题目：一项II 期SPUR研究：多周期低剂量放射治疗重塑免疫化疗在广泛期小细胞肺癌中的应用展示形式：壁报导览场次：PT2.13 - Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：2316牵头主要研究者：卢铀 四川大学华西医院展示时间：2025年9月8日 下午2:23-2:31（西班牙时间）论文题目：斯鲁利单抗新辅助治疗局晚期非小细胞肺癌的一项前瞻性单臂研究展示形式：壁报场次：P2.08 - Local-Regional Non-small Cell Lung Cancer摘要编号：1954牵头主要研究者：曾剑 浙江省肿瘤医院展示时间：2025年9月8日上午10:30-12:00（西班牙时间）论文题目：PS评分≥2的广泛期小细胞肺癌患者的一线免疫联合化疗结果：来自ASTRUM-005R的真实世界证据展示形式：壁报场次：P3.13-Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号：1534牵头主要研究者：邬麟 湖南省肿瘤医院，胡成平 中南大学湘雅医院展示时间：2025年9月9日上午10:00-11:30（西班牙时间）论文题目：一线免疫化疗在广泛期小细胞肺癌中的荟萃分析：ECOG 体能状态评分≥2 是否影响生存结局？展示形式：电子壁报摘要编号：1885牵头主要研究者：余新民  浙江省肿瘤医院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，已有6款产品在中国获批上市，4款产品在国际获批上市，5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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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。