Sacituzumab govitecan-hziy

编译：肿瘤资讯 来源：SABCS官网 三阴性乳腺癌（TNBC）因具有高度异质性且缺乏明确治疗靶点，长期以来是临床管理的难点。在2025年圣安东尼奥乳腺癌研讨会（SABCS）上，“如何治疗三阴性乳腺癌——三阴性不再消极（How to Treat TNBC—Triple-Negative Not so Negative Anymore）”教育专场整合最新循证医学证据，向学界传递出明确信号：TNBC的治疗逻辑正发生根本性转变。本次专场由Marlene Kok教授主持，汇聚了早期、局部晚期及转移性乳腺癌领域的权威专家与患者权益代表，旨在为临床医生提供一份更新的TNBC全病程管理指引。 I期TNBC的治疗决策 I期TNBC（肿瘤≤2cm，无淋巴结转移）的治疗决策始终是临床争议焦点。Elie Rassy教授通过详实的数据分析，探讨了如何在保障疗效的前提下，规避过度治疗带来的长期毒性。 1. 辅助化疗的分层标准 尽管指南通常建议TNBC患者接受化疗，但Rassy教授指出，并非所有I期患者均可从中获益。通过回顾美国监测、流行病学与最终结果（SEER）数据库（n=8601）及多项回顾性研究，他提出了更精细的分层建议： T1a N0（肿瘤＜5mm）：此类患者预后极佳，化疗并未显著降低复发风险，因此通常不推荐辅助化疗； T1c N0（肿瘤＞10mm）：这是明确的化疗指征区间。依据美国临床肿瘤学会（ASCO）和欧洲肿瘤内科学会（ESMO）指南，此类患者以辅助化疗为标准治疗；对于存在高危因素（如Ki-67高表达、脉管侵犯、肿瘤贴近切缘需保乳）的人群，可考虑新辅助治疗以优化手术策略； T1b N0（肿瘤5-10mm）：这是临床决策的难点。数据显示，化疗虽能降低该亚群患者的复发风险，但绝对获益有限。Rassy教授建议将肿瘤5mm作为考虑化疗的起始值，并结合患者年龄、身体状态实施个体化治疗决策。 2. 蒽环类药物的去留 下一个问题是，确定需化疗后，是否必须包含蒽环类药物？Rassy教授引用丹麦乳腺癌协作组（DBCG）07-READ研究、PlanB研究等关键数据指出，在I期TNBC患者中，无蒽环方案（如TC方案：多西他赛+环磷酰胺，6周期）的10年无病生存期（DFS）和总生存期（OS），与含蒽环方案（如EC-T方案）相比无统计学差异。因此，对于心脏毒性风险较高或希望降低治疗毒性的I期TNBC患者，去蒽环方案已成为循证医学支持的标准选择。 3. TILs：超越解剖分期的预后指标 肿瘤浸润淋巴细胞（TILs）不仅是免疫微环境的反映，更是极强的预后保护因素。Rassy教授展示了多中心汇总分析的数据： 未接受化疗的I期TNBC患者中，TILs水平每增加10%，侵袭性疾病复发或死亡风险降低约14%； 当TILs≥30%时，患者预后显著改善；而TILs≥50%时，患者5年总生存率可达95%以上，且该获益独立于化疗。 这些数据提示，高TILs水平的I期TNBC患者未来或可完全豁免化疗。目前，ETNA、OPTImaL等前瞻性临床试验正基于此逻辑，旨在验证基于TILs豁免化疗的可行性，有望改写未来的诊疗指南。 II/III期TNBC的强化治疗 对于复发风险较高的II/III期TNBC，治疗目标明确指向病理学完全缓解（pCR）——这是患者长期生存的替代终点。Gustavo Werutsky教授详细梳理了此类人群的新辅助治疗的现状及未来方向。 1. KEYNOTE-522：“欲戴王冠，必承其重” 目前，高危早期TNBC的标准治疗已确立为“帕博利珠单抗+化疗（含卡铂）”新辅助方案（KEYNOTE-522模式）。该方案将pCR率提升至64.8%，并显著改善无事件生存期（EFS）。然而，Werutsky教授强调，临床医生必须正视其伴随的挑战： 免疫相关不良事件（irAEs）：约14.9%的患者会出现3级及以上irAEs，甲状腺功能异常、肾上腺功能不全等内分泌毒性往往需要终身治疗； 真实世界数据与临床试验的差距：真实世界研究显示，受剂量强度调整、不良反应管理等因素影响，实际pCR率略低于临床试验数据，且停药率更高； 2. 针对Non-pCR患者的治疗升级 新辅助治疗后仍有残留病灶（Non-pCR）的TNBC患者预后较差，目前的标准辅助治疗包括卡培他滨（CREATE-X研究）或奥拉帕利（OlympiA研究，针对gBRCA突变患者）。 Werutsky教授指出，未来的发展趋势是将抗体药物偶联物（ADC）前移至新辅助阶段。例如，TROPION-Breast04研究正探索Dato-DXd联合免疫治疗在新辅助阶段的应用，试图替代传统化疗，以期在降低治疗毒性的同时提高pCR率，从源头改善高危患者的预后。 3. ctDNA：指导治疗调整的动态标尺 如何更早识别高危患者？Werutsky教授重点介绍了循环肿瘤DNA（ctDNA）的应用前景： 新辅助阶段：ctDNA的早期清除与pCR高度相关，可作为早期疗效的预测指标； 辅助阶段：ctDNA阳性是复发的预测因子之一，通常早于影像学检查发现复发迹象。 未来的治疗模式或将基于ctDNA状态进行动态调整——例如ZEST试验对术后ctDNA阳性患者使用PARP抑制剂进行干预。这种以微小残留病灶（MRD）为驱动的治疗策略，将比传统解剖学分期更为精准。 晚期TNBC的治疗格局 晚期TNBC的治疗已发生颠覆性变化。Sara Tolaney教授通过梳理一线及后线治疗的最新数据，描绘了以ADC药物为核心的治疗图谱。 1. 一线治疗：免疫联合与ADC的博弈 PD-L1阳性（CPS≥10）：目前的标准方案为化疗联合帕博利珠单抗（KEYNOTE-355研究）。但最新的ASCENT-04研究显示，戈沙妥珠单抗（SG）联合帕博利珠单抗相比化疗联合免疫治疗，显著延长了无进展生存期（PFS，HR 0.65），且总生存期（OS）呈现获益趋势。这一组合有望成为PD-L1阳性晚期TNBC患者新的优选方案； PD-L1阴性：这是传统化疗疗效最差的人群。ASCENT-03（SG）和TROPION-Breast02（Dato-DXd）两项研究均证实，ADC药物在一线治疗中显著优于传统化疗。 药物选择策略：Tolaney教授建议根据毒性谱选择药物。SG的主要毒性为中性粒细胞减少和腹泻，Dato-DXd则需重点关注口腔炎和干眼症；此外，Dato-DXd在早期复发（＜6个月）人群中拥有更具体的数据支持。 2. 特殊人群：gBRCA突变患者的排兵布阵 对于携带gBRCA突变的晚期TNBC患者，治疗选择需综合考量PD-L1状态： PD-L1阴性：鉴于PARP抑制剂的生活质量获益优于化疗和ADC，且一线应用时PFS获益更显著，建议优先使用PARP抑制剂； PD-L1阳性：鉴于免疫治疗在后线应用时疗效大幅下降，建议一线优先使用含免疫方案（如免疫+化疗或免疫+ADC），将PARP抑制剂留作后线治疗。 3. 后线治疗困境与ADC序贯使用 随着ADC药物前移至一线治疗，二线及后线治疗面临新的挑战。Tolaney教授指出，ADC治疗进展后转回传统化疗的疗效极差（PFS仅约2~3个月）。 目前的探索方向是ADC的序贯使用（如SG进展后使用T-DXd）。尽管拓扑异构酶载体交叉耐药等机制导致疗效有所降低，但真实世界数据显示，其PFS仍优于化疗。此外，针对HER2超低表达（Ultra-low）人群的T-DXd应用、靶向B7H4等新靶点的ADC药物研发，是解决后线耐药问题的关键突破口。 患者视角的治疗考量 会议最后，一位晚期TNBC长期幸存者Janice Cowden女士结合患者分享了自己就诊多年的真实体验。作为患者权益代表，Cowden女士指出临床研究在追求疗效数据的同时，须关注患者的实际生存质量。 1. 真实世界中的ADC毒性负担 Cowden女士分享了一项由患者组织发起的ADC药物体验调查（PCDI）结果：超过80%的患者经历了严重影响日常生活的副作用，其中使用SG的患者中约42%需要下调剂量。这提示临床试验中报告的不良反应数据可能低估了患者在真实生活中的困扰。 “最大耐受剂量”与“患者中心剂量” 她提出了一个引人深思的观点：肿瘤学传统剂量设定多基于最大耐受剂量，但晚期乳腺癌需长期维持治疗，属于慢病管理模式；许多患者通过主动调整剂量，反而获得了更长的治疗持续时间和更好的生活质量。因此，Cowden女士呼吁临床医生制定治疗方案时，应结合患者的耐受性和生活诉求灵活调整剂量，避免因治疗毒性过高导致患者过早终止有效治疗。 总结 2025年SABCS的这场TNBC专场会议，清晰勾勒出该领域从“解剖学分期”向“生物学分层”演进的轨迹： 在早期TNBC领域，利用TILs等生物标志物筛选低危人群，推行化疗降阶梯策略； 在高危局部晚期TNBC领域，通过新辅助免疫联合治疗及潜在的ADC前移应用，最大化pCR获益； 在晚期TNBC领域，ADC药物已全面重塑一线及后线治疗格局，即便是PD-L1阴性患者也迎来了强效治疗选择。 未来的挑战将集中在两方面：一是如何利用ctDNA等工具实现动态精准监控；二是如何在患者生存时间不断延长的背景下，通过剂量优化以提升患者的生活质量。 责任编辑：肿瘤资讯-Ethon 排版编辑：肿瘤资讯-slb 版权声明 本文专供医学专业人士参考，未经著作人许可，不可出版发行。同时，欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明"转自：良医汇-肿瘤医生APP"。

2026年1月27日，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，抗PD-1单抗）及其自研的重组抗EGFR单克隆抗体HLX07用于晚期实体瘤治疗的临床试验申请获中国国家药品监督管理局（NMPA）批准。近年来，免疫检查点抑制剂（以抗PD-1/L1抗体为代表）已成为癌症治疗的重要手段之一。然而，部分患者对该疗法无响应，或者从单药中获益有限1，由此推动了联合治疗策略的发展，其中免疫联合化疗已成为多种肿瘤的一线标准治疗方案。随着新型疗法的涌现，免疫联合用药的选择日益丰富。抗体偶联药物（ADC）在肿瘤治疗中已展现出卓越的临床疗效，其与免疫疗法的组合（IO+ADC）不仅能产生协同抗肿瘤效应，更有望提升应答率并克服耐药，成为最具潜力的免疫联用方向2。目前，IO+ADC的治疗方案已在尿路上皮癌中率先获批3，在胃癌、非小细胞肺癌、乳腺癌、头颈鳞癌等实体瘤中，多项IO+ADC的联合疗法也显示出突出治疗潜力，有望成为未来肿瘤免疫治疗的主线疗法4-5。EGFR（表皮生长因子受体）过表达被认为是肺癌、结直肠癌、头颈鳞癌等恶性肿瘤发展的重要驱动机制，成为实体瘤治疗中已验证的关键靶点之一6。尽管EGFR靶向疗法包括西妥昔单抗等已显著改变了多种癌症的治疗格局，但EGFR的异常激活可导致免疫逃避，创造免疫抑制的微环境，单一药物靶向治疗效果有限。已有研究表明，西妥昔单抗与伊立替康（一类拓扑异构酶抑制剂）的联合疗法在转移性结直肠癌的治疗中展现出显著优势，目前已获批用于该病的一线及后线治疗7-8。此外，“抗PD-1/L1单抗+抗EGFR抗体”、“抗PD-1/L1单抗+抗EGFR抗体+化疗”的联合用药方案也在头颈鳞癌、皮肤鳞癌、结直肠癌等多种实体瘤的后线、辅助及新辅助治疗领域进行探索9-12。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。H药 汉斯状（斯鲁利单抗）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，同时是全球首个一线治疗小细胞肺癌的抗PD-1单抗。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。HLX07是复宏汉霖自主开发的创新型抗EGFR的单抗，相比西妥昔单抗该产品具备更低的免疫原性和更好的靶点亲和力。此前，公司已启动HLX43与斯鲁利单抗以及HLX43与HLX07联合用于晚期实体瘤治疗的临床探索。基于H药 汉斯状（斯鲁利单抗）、PD-L1 ADC HXL43展现出的广谱治疗潜力，抗EGFR单抗HLX07联合斯鲁利单抗±化疗积极的临床数据，公司计划在两药联合治疗方案（HLX43联合斯鲁利单抗、HLX43联合HLX07）的基础上，进一步拓展至三药联合方案，有望通过双免疫阻断和精准靶向的协同机制，最大化公司多款核心创新分子的治疗潜力。未来，复宏汉霖将继续秉持“以患者为中心”的初心和理念，深耕实体瘤这一重要疾病领域，通过不断挖掘患者未满足的临床需求，持续夯实更多创新分子的差异化布局，为更多肿瘤患者带来高质量、可负担的新型治疗方案。【参考文献】 Attili I, et al. 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Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study.[J].Journal of Clinical Oncology, 2025, 43(17_suppl):LBA109-LBA109. Mitsudomi T, Yatabe Y. Epidermal growth factor receptor in relation to tumor development: EGFR gene and cancer[J]. Febs Journal, 2010, 277(2):301-308 E Van Cutsem, CH Köhne, E Hitre et al. Cetuximab and chemotherapy as initial treatment formetastatic colorectal cancer. N Engl J Med. 2009, 360: 1408-1417. I LLC. Cetuximab FDA label. 2021.09.24. AG Sacco, R Chen, FP Worden et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2021, 22: 883-892. JI D, SANG Y, et al. A phase Ⅱ clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)［J］. Ann Oncol, 2024, 35: S626. YAO Z W, WANG J S, et al. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma［J］. Head Neck, 2025, 47(1): 289-299. Yi-Long Lung Cancer Wu et al. A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer. J Clin Oncol 43, 8561-8561(2025).关于HLX43HLX43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I期临床数据于2025美国临床肿瘤学会（ASCO）年会及2025 世界肺癌大会（WCLC）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，HLX43在宫颈癌、食管鳞癌等实体瘤中的II期POC验证数据也陆续读出，验证了其在实体瘤领域的广泛治疗潜力。关于H药 汉斯状H药 汉斯状（斯鲁利单抗）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，获CDE突破性疗法认定且其上市许可申请正式纳入优先审评审批程序，同时是全球首个一线治疗小细胞肺癌的抗PD-1单抗。自2022年上市以来，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（nsNSCLC) 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。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，在肺癌和胃癌领域皆斩获全球突破性进展，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，并获得美国、欧盟、瑞士、韩国、墨西哥孤儿药资格认定。关于HLX07HLX07是复宏汉霖自主开发的创新型抗EGFR的单抗，相比西妥昔单抗该产品具备更低的免疫原性和更好的靶点亲和力。目前，公司围绕肺鳞癌、皮肤鳞癌、鼻咽癌、食管鳞癌等多个实体瘤适应症，积极开展HLX07单药或联合H药 汉斯状（斯鲁利单抗）的II期临床探索。根据2025 WCLC最新数据发布，HLX07联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者一线治疗中展现出显著的抗肿瘤活性和持久疗效，在中位随访18.6个月时实现了约70%的客观缓解率（ORR）和超过90%的疾病控制率（DCR），高剂量组的中位无进展生存期（PFS）更达到17.4个月，表明抗EGFR单抗与PD-1/L1抑制剂的联用，不仅阻断EGFR生长信号，更同步激活免疫应答，极具联合协同治疗潜力。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10款产品，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）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。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。Henlius Receives an IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Anti-PD-1 mAb Serplulimab and Novel Anti-EGFR mAb HLX07Shanghai, China, January 27, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for a clinical trial of HLX43, the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced solid tumors.Immune checkpoint inhibitors represented by anti-PD-1/PD-L1 monoclonal antibodies have become a cornerstone of cancer treatment. However, there are still many patients who do not respond to or derive limited benefit from monotherapy1, which has fueled the development of combination strategies. Among these, immunochemotherapy has become a first-line standard of care for multiple tumor types. As novel therapies expand the combination immunotherapy landscape, antibody-drug conjugates (ADCs) have emerged as a highly effective option. Their combination with immunotherapy (IO) may create synergy for more potent and durable responses while overcoming resistance, thereby addressing critical unmet clinical needs2. A major breakthrough has been the approval of an IO-ADC combination as first-line treatment for advanced urothelial cancer3. This success has accelerated exploration in other solid tumors like gastric cancer (GC), non-small cell lung cancer (NSCLC), breast cancer (BC), and head and neck squamous cell carcinoma (HNSCC), positioning it as a key next-generation approach4-5.EGFR (Epidermal Growth Factor Receptor) overexpression is considered a crucial driving mechanism in the development of various malignant tumors, including lung cancer, colorectal cancer (CRC), and HNSCC, establishing it as one of the validated key targets in solid tumor treatment6. Although EGFR-targeted therapies, such as cetuximab, have significantly altered the treatment landscape for many cancers, abnormal EGFR activation can lead to immune evasion and create an immunosuppressive microenvironment, resulting in limited efficacy for single agent targeted therapy. Previous studies have shown that combination of cetuximab and irinotecan (a topoisomerase inhibitor) demonstrates potent efficacy in metastatic colorectal cancer, and is now approved for both first-line and later-line treatment of the disease7-8. Furthermore, strategies of "anti-PD-1/L1 mAb plus anti-EGFR mAb" and "anti-PD-1/L1 mAb plus anti-EGFR mAb plus chemotherapy" are widely explored in the later-line, adjuvant, and neoadjuvant settings for various solid tumors, including HNSCC, cutaneous squamous cell carcinoma (CSCC) and CRC9-12. HLX43 is a potentially best-in-class pan-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. 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. Serplulimab (HANSIZHUANG) is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, and the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). It has shown unique advantages in various solid tumors via its differentiated mechanism. HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. The company has initiated clinical trials of HLX43 in combination with serplulimab, as well as HLX43 combined with HLX07, for the treatment of advanced solid tumors. Leveraging the broad therapeutic potential of serplulimab and the PD-L1 ADC HLX43, along with encouraging clinical data for the anti-EGFR mAb HLX07 plus serplulimab with or without chemotherapy, the company plans to expand from two ongoing dual combination therapies—HLX43 plus serplulimab and HLX43 plus HLX07—into a triple-combination regimen. This strategy aims to maximize the clinical value of its core innovative products by harnessing the synergistic effects of dual immune checkpoint blockade and precision targeting.By strategically prioritizing solid tumor domain as a core therapeutic area, Henlius continues to uphold its patient-centric mission, accelerating differentiated innovation to address unmet medical needs and delivering high-quality, affordable therapies to tumor patients worldwide.About HLX43HLX43 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. The results from the phase 1 clinical trial of HLX43 were released at the 2025 ASCO Annual Meeting and 2025 WCLC, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. In addition, phase 2 proof of concept (POC) data of HLX43 in CC and ESCC continue to emerge, providing compelling new evidence for its pan-tumor therapeutic potential.About SerplulimabSerplulimab is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, to receive Breakthrough Therapy Designation from the CDE as well as being granted Priority Review for the treatment of this indication. Meanwhile, it is the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). Up to date, serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC). It has been approved in over 40 countries and regions including China, the U.K., Germany, Singapore, and India, covering nearly half of the global population and accelerating global accessibility. Serplulimab demonstrates unique advantages in various solid tumors via its differentiated mechanism, especially achieving groundbreaking progress in both lung and gastric cancers. 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. It has also received orphan drug designations granted by the US FDA, the European Commission, Swissmedic, Korea MFDS and Mexico COFEPRIS.About HLX07HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with serplulimab for the treatment of solid tumors including sqNSCLC, CSCC, nasopharyngeal carcinoma (NPC) and ESCC. According to the updated results in 2025 WCLC, the combination of HLX07 with serplulimab and chemotherapy demonstrated remarkable antitumor activity and durable efficacy as first-line treatment for patients with EGFR overexpression sqNSCLC. At a median follow-up of 18.6 months, both dose groups achieved an objective response rate (ORR) of around 70% and a disease control rate (DCR) of over 90%. The median progression-free survival (PFS) reached 17.4 months in the high-dose group. This indicates that the combination of HLX07 and serplulimab blocks EGFR signaling while activating immune responses, supporting strong therapeutic synergy. About HenliusHenlius (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, 10 products have been approved for marketing across multiple countries and regions, 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 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, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.返回搜狐，查看更多