复宏汉霖HLX22头对头K药胃癌III期临床美国研究者会顺利举行，全球开发协同进一步提速

HLX22作为靶向HER2的新表位单克隆抗体，能够与曲妥珠单抗同时结合至HER2，有效促进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40%-80%，产生更强的HER2受体阻断效果。HLX22联合曲妥珠单抗治疗HER2阳性胃癌的II期临床研究HLX22-GC-201的更新结果已于2025年美国临床肿瘤学会（ASCO）年会发布，数据显示经过长期随访（中位随访周期超2年），HLX22在HER2阳性胃癌治疗中依然展现出稳定的疗效获益，远超历史数据¹。HLX22-GC-301研究是一项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，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，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。

该研究的美国主要研究者、医学博士（M.D.）、纪念斯隆-凯特琳癌症中心消化道肿瘤科主任、Petrie讲席教授Yelena Janjigian表示

复宏汉霖全球产品开发部副总裁李靖表示

通过本次研究者会，复宏汉霖与美国研究者团队进一步加深了在研究方案理解、患者管理及试验执行标准方面的共识，有助于提升研究在不同区域开展过程中的一致性与规范性，为HLX22-GC-301研究的高质量推进提供有力保障。未来，复宏汉霖将持续携手全球临床专家网络，加速推进HLX22等创新产品的国际临床开发进程，为HER2阳性胃癌患者探索更多具备临床价值的新治疗选择。

声明：Janjigian博士为复宏汉霖提供咨询服务。

Henlius Holds U.S. Investigator Meeting for HLX22-GC-301, a Head-to-Head Phase 3 Trial vs Standard of Care (±Pembrolizumab) in HER2+ Gastric Cancer

Recently, Shanghai Henlius Biotech, Inc. (2696.HK) successfully held an in-person investigator meeting in San Francisco for the HLX22-GC-301 trial. The meeting focused on the global, multicentre Phase 3 clinical trial evaluating the novel epitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy as first-line treatment for HER2-positive advanced gastric cancer. Nearly 30 leading oncologists and clinical researchers from more than 20 clinical trial sites, including The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, attended the meeting. Participants engaged in in-depth discussions on the current treatment landscape for HER2-positive metastatic gastric cancer, safety management of HER2-targeted therapies, and key aspects of the HLX22-GC-301 trial protocol. The HLX22-GC-301 trial is co-led globally by Dr. Lin Shen of Beijing Cancer Hospital and Dr. Jaffer A. Ajani, Professor of Medicine at University of Texas MD Anderson Cancer Center. The trial has completed the dosing of the first patient across multiple countries and regions, including China, the United States, Japan, Australia, and Argentina.

HLX22 is a novel monoclonal antibody targeting a unique epitope on HER2. It can bind to HER2 simultaneously with trastuzumab, significantly enhancing the internalization and degradation of HER2 homodimers and HER2/EGFR heterodimers, increasing HER2 internalization efficiency by 40%–80% and resulting in stronger HER2 receptor blockade. Updated results from the Phase 2 HLX22-GC-201 trial, evaluating HLX22 in combination with trastuzumab in HER2-positive gastric cancer, were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. With a median follow-up of over two years, the combination continued to demonstrate durable and clinically meaningful efficacy, exceeding historical benchmarks.¹ HLX22-GC-301 is a randomized, head-to-head, international multicentre Phase 3 trial comparing HLX22 plus trastuzumab and chemotherapy with the current standard first-line regimen (trastuzumab plus chemotherapy ± pembrolizumab). The trial includes patients regardless of PD-L1 expression status and aims to address the limitations of current first-line treatment options for HER2-positive metastatic gastric and gastroesophageal junction cancer.

Dr. Jaffer A. Ajani, M.D., Global Principal Investigator of the HLX22-GC-301 trial, Chair of the NCCN Gastric and Esophageal Cancers Panel, Professor of Medicine at University of Texas MD Anderson Cancer Center, commented: “HLX22 is a unique monospecific antibody directed to the extracellular domain 4 of the HER2 receptor. Mature results of a randomized phase 2 data are very encouraging when HLX22 is combined with trastuzumab and chemotherapy, compared to the placebo with trastuzumab and chemotherapy. Based on these results, the pivotal HLX22 Gastric Cancer phase 3 study (HLX22-GC-301) is rapidly accruing patients globally and we look forward to changing the therapeutic landscape in this space.”

Dr. Yelena Janjigian, M.D., U.S. Principal Investigator of the HLX22-GC-301 trial and Petrie Chair and Chief of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, stated: “First-line treatment is the most critical opportunity to impact long-term outcomes in HER2-positive gastric and gastroesophageal cancer. HLX22 is a unique and well-tolerated HER2-targeted antibody designed to deepen HER2 blockade beyond what is achievable with current approaches. The Phase 3 HLX22-GC-301 trial is an important step toward defining whether more complete HER2 inhibition can meaningfully improve outcomes for patients in the frontline setting.”

Jing Li, Vice President of Global Product Development at Henlius, said: “The U.S. investigator team plays a critical role in trial design interpretation, patient management, and execution quality for HLX22-GC-301. This investigator meeting provided an important platform for alignment and in-depth communication across sites, helping to further enhance consistency and standardization of trial implementation across regions. Henlius will continue to advance global clinical development to the highest standards, working closely with our international investigator partners to accelerate the global clinical validation and value realization of the differentiated innovative asset HLX22.”

Through this investigator meeting, Henlius and the U.S. investigator community further strengthened alignment on trial protocol understanding, patient management strategies, and trial execution standards, helping improve the consistency and standardization of the trial execution in different regions, which provides strong support for the high-quality advancement of the HLX22-GC-301 trial. Looking ahead, Henlius will continue to collaborate closely with its global clinical network to accelerate the international development of HLX22 and other innovative assets, and to explore more clinically meaningful treatment options for patients with HER2-positive gastric cancer worldwide.

Dr. Janjigian provides advisory services to Henlius.

媒体：PR@Henlius.com

投资者：IR@Henlius.com