2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）将于2026年1月8日至10日在加利福尼亚州旧金山举行。本届大会上，复宏汉霖（2696.HK）将首次公布其广谱抗肿瘤PD-L1抗体偶联药物（ADC）HLX43治疗晚期食管鳞癌（ESCC）的II期概念验证数据；同时，抗PD-1单抗H药 汉斯状 ® 在结直肠癌领域的两项新辅助研究结果， 新表位HER2单抗HLX22 头对头国际多中心III期临床设计 也将亮相，共同呈现公司在消化道肿瘤领域的创新布局与最新进展。
HLX43：广谱抗肿瘤、兼具IO疗效的潜在同类最优PD-L1 ADC
HLX43是一款潜在同类最优的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，对于鳞状/非鳞状NSCLC，有无EGFR突变、有无脑转移、PD-L1阳性/阴性的NSCLC患者人群都具有疗效，不依赖生物标志物筛选。
同时，HLX43在胸腺癌、宫颈癌等瘤种中的初步临床数据也陆续读出，验证了其在实体瘤领域的广泛治疗潜力。目前，复宏汉霖已累计开展约10项HLX43治疗多项实体瘤中的临床研究，广泛覆盖肺癌、宫颈癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管交界部癌、胰导管腺癌、肝细胞癌等，在全球入组超过500例患者。此次ASCO GI大会上，复宏汉霖将首次公布HLX43在复发/转移性食管鳞癌患者中的II期概念验证数据，再度验证这款PD-L1 ADC在消化道高发瘤种中的治疗潜力，进一步拓展其广谱抗肿瘤版图。
论文题目： 一项评估 HLX43 (抗 PD-L1 ADC)在复发/转移性食管鳞癌中有效性和安全性的多中心、随机的II 期临床研究
A multicenter, randomized phase 2 study evaluating the efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma
展示形式 ： Poster（壁报）
场次： Poster（壁报）Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
展板/报告编号： C21
牵头主要研究者： 于金明，山东省肿瘤医院
展示时间： 2026年1月8日上午11:30- 下午1:00，下午6:00-7:00（太平洋时间）
H药 汉斯状 ® （斯鲁利单抗）：全球首个且唯一胃癌围术期III期注册研究成功的抗PD-1单抗
H药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。此次ASCO GI大会上，复宏汉霖将公布斯鲁利单抗在晚期结直肠癌中的两项II期新辅助治疗研究结果，揭示其在高危局部晚期结肠癌中提升根治性手术机会的重要价值，并为晚期直肠癌患者“优化”治疗路径，挑战以免疫联合化疗替代放疗。
论文题目： 新辅助短程放疗联合 CAPOX 方案与 PD-1 抑制剂用于 MSS/pMMR 高危局部晚期结肠癌：一项随机、前瞻性、多中心 Ⅱ 期试验（TORCH-C）
Neoadjuvant short-course radiotherapy combined with CAPOX and PD-1 inhibitor for MSS/pMMR high-risk locally advanced colon cancer: A randomized, prospective, multicentre, phase II trial (TORCH-C)
展示形式 ： Poster（壁报）
场次： Poster Session C: Cancers of the Colon, Rectum, and Anus
展板/报告编号： F11
牵头主要研究者： 蔡三军&章真，复旦大学附属肿瘤医院
展示时间： 2026 年1月10日上午7:00-7:55（太平洋时间）
论文题目： 新辅助化疗联合斯鲁利单抗用于 MSS/pMMR 局部晚期直肠癌（FIRM 研究）：一项 Ⅱ 期临床试验
Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): a phase II trial
展示形式 ： Poster（壁报）
场次： Poster Session C: Cancers of the Colon, Rectum, and Anus
展板/报告编号： E7
牵头主要研究者： 杜鹏，上海交通大学医学院附属新华医院
展示时间： 2026 年1月10日上午7:00-7:55（太平洋时间）
HLX22（新表位HER2单抗）：有望革新全球HER2+胃癌一线标准疗法
HLX22为靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得该产品能够与曲妥珠单抗同时结合至HER2，有效促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，将HER2的内吞效率提高了40%-80%，进而产生更强的HER2受体阻断效果。HLX22头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）的国际多中心III期研究（HLX22-GC-301）目前已在中国、美国、日本、澳大利亚、阿根廷等多个国家和地区启动入组，旨在评估HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性转移性GC/GEJC患者的疗效与安全性。该研究不限PD-L1表达人群，致力于突破当前HER2阳性胃癌一线治疗的临床局限。此外，HLX22于2025年获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。继胃癌之后，HLX22与德曲妥珠单抗的联合疗法已拓宽至乳腺癌疾病领域，有望为更多肿瘤患者带来新的治疗选择。
论文题目： 一项比较HLX22联合曲妥珠单抗和化疗对比曲妥珠单抗和化疗联合或不联合帕博利珠单抗一线治疗HER2阳性局部晚期或转移性胃/胃食管结合部癌的疗效与安全性的随机、双盲、国际多中心III期临床试验
A randomized, double-blind, international phase 3 trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJC
展示形式 ： Poster（壁报）
场次： Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
展板/报告编号： J24
牵头主要研究者： 沈琳，北京大学肿瘤医院；Jaffer A. Ajani，MD安德森癌症中心
展示时间： 2026 年1月8日上午11:30-下午1:00（太平洋时间）
Henlius Debuts HLX43 Phase 2 ESCC Data at ASCO GI, Alongside Updates on Serplulimab and Novel Epitope HER2 mAb HLX22
The 2026 American Society of Clinical Oncology Gastrointestinal Cancers Sympotsium (ASCO GI 2026) will be held in San Francisco, California from Januarary 8 to 10, 2026. At this year's conference, Henlius (2696.HK) will, for the first time, showcase the Phase 2 proof-of-concept data for its broad-spectrum anti-tumor PD-L1 antibody-drug conjugate (ADC) HLX43 in the treatment of advanced esophageal squamous cell carcinoma (ESCC). Additionally, results from two neoadjuvant studies of serplulimab, the anti-PD-1 monoclonal antibody (mAb) in colorectal cancer and the p hase 3 study design of a head-to-head, multi-regional clinical trial for the novel epitope anti-HER2 mAb HLX22 will be released. These presentations together showcase the company's innovative layout and advancements in the field of gastrointestinal cancers.
HLX43: A Potential Best-in-Class PD-L1 ADC with Broad-Spectrum Anti-Tumor Activity and Immuno-Oncology Efficacy
HLX43 is a potential best-in-class broad-spectrum anti-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 good anti-tumor effects 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, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain metastasis, and PD-L1 positive or negative patients.
Meanwhile, preliminary clinical data for HLX43 have been observed in thymic carcinoma (TC) and cervical cancer (CC), with more data expected from other tumor types, reforcing its broad therapeutic potential across solid tumors. To date, Henlius has initiated about 10 clinical studies of HLX43, covering lung cancer, CC, ESCC, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), colorectal cancer, gastric/gastroesophageal junction cancer (G/GEJ), pancreatic ductal adenocarcinoma (PDAC), and hepatocellular carcinoma (HCC), with over 500 patients enrolled globally. At the upcoming ASCO GI conference, Henlius will, for the first time, release the Phase 2 proof-of-concept data for HLX43 in patients with recurrent/metastatic ESCC, further validating the therapeutic potential of the product in gastrointestinal cancers and expanding its broad-spectrum anti-tumor profile.
Title ：A multicenter, randomized phase 2 study evaluating the efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma
Format ：Poster
Session ：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number ：C21
Leading PI ：Jingming Yu, Shandong Cancer Hospital
Time ：Jan 8, 2026, 11:30 AM-1:00 PM; 6:00 PM-7:00 PM (PST)
Serplulimab: World's First and Only Anti-PD-1 mAb with Positive Results from a Phase 3 Registrational Trial in the Perioperative Rreatment of Gastric Cancer
Serplulimab 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. Meawhile, 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 treating 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. At the conference, Henlius will present findings from two Phase 2 neoadjuvant studies of serplulimab in advanced colorectal cancer. The data highlight its potential to improve opportunities for curative surgery in high-risk locally advanced colon cancer and "optimize" treatment pathways for patients with advanced rectal cancer—challenging the current standard by exploring immunotherapy combined with chemotherapy as an alternative to radiotherapy.
Title ：Neoadjuvant short-course radiotherapy combined with CAPOX and PD-1 inhibitor for MSS/pMMR high-risk locally advanced colon cancer: A randomized, prospective, multicentre, phase II trial (TORCH-C)
Format ：Poster
S ession ：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number ：F11
Leading PI ：Sanjun Cai, Zhen Zhang, Fudan University Shanghai Cancer Center
Time ：Jan 10, 2026, 7:00 AM-7:55 AM (PST)
Title ：Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): a phase II trial
Format ：Poster
Session ：Poster Session C: Cancers of the Colon, Rectum, and Anus
Presentation Number ：E7
Leading PI ：Peng Du, Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine
Time：Jan 10, 2026, 7:00 AM-7:55 AM (PST)
HLX22：Shows Potential to Redefine the Global First-Line Treatment Landscape for HER2-Positive Gastric Cancer
HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, resulting in a 40%–80% increase in HER2 internalisation.
HLX22-GC-301 is a randomized, double-blind, international Phase 3 trial directly comparing HLX22 in combination with trastuzumab and chemotherapy versus the current first-line standard of care (trastuzumab + chemotherapy ± pembrolizumab) for HER2-positive advanced gastric cancer.
The trail is designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC), in direct comparison with the current standard regimen of trastuzumab plus chemotherapy, with or without pembrolizumab. It has been initiated across multiple countries and regions, including China, the United States, Japan, Australia and Argentina. Notably, HLX22-GC-301 does not limit enrolment by PD-L1 status, aiming to overcome clinical limitations of current first-line treatment paradigms for HER2-positive gastric cancer. In recognition of its potential, HLX22 has been granted Orphan Drug Designation (ODD) for gastric cancer by both the U.S. FDA and the European Commission in 2025, highlighting its global development prospects and clinical value.
Title ：A randomized, double-blind, international phase 3 trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab andchemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJC
Format ：Poster
Session ：Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers
Presentation Number：J24
Co-leading PI ：Lin Shen, Peking University Cancer Hospital; Jaffer A. Ajani, MD Anderson Cancer Center
Time ：Jan 8, 2026, 11:30 AM-1:00 PM (PST)
About Henlius
排版编辑：肿瘤资讯-as
苏公网安备32059002004080号
