复宏汉霖HLX22头对头K药胃癌III期临床拉美研究者会在巴西成功召开 加速创新药全球开发进程

胃癌是拉美地区高发癌种，据GLOBOCAN数据显示，在拉美地区，胃癌的癌症发病率和死亡率中均位列第6位^[1]。多数胃癌患者早期症状隐匿，确诊时已处于疾病晚期，总体预后不良，5年生存率仅为6%^[2,3]。尽管近年来靶向治疗（如抗HER2药物）和免疫检查点抑制剂（如抗PD-1/PD-L1单抗）在胃癌的治疗中取得了一定进展^[4]，但鉴于该疾病具有高度分子异质性，不同亚型患者对化疗、靶向治疗和免疫治疗的反应差异显著^[5]。免疫治疗局限于PD-L1阳性人群，且疗效改善有限。胃癌尤其是HER2阳性胃癌的整体治疗仍存在巨大的未满足的临床需求。

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-GC-301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。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。

HLX22-GC-301研究的牵头主要研究者、北京大学肿瘤医院沈琳教授在线上致辞中表示

智利RedSalud癌症研究所

Juan Pablo Miranda Olivares博士表示

秘鲁肿瘤学和放射治疗研究所

Manuel Philco博士表示

阿根廷Pergamino研究中心

Susana Kahl博士表示

复宏汉霖临床运营副总经理

于浩宇表示

本次研究者会通过深入交流，进一步明确了拉美地区患者管理、诊疗标准与临床试验实施规范，为后续临床工作奠定了坚实基础。未来，复宏汉霖将继续秉持“持续创新，卓越运营；以优质生物药，造福全球病患”的使命，加速推进HLX22等创新药的全球临床开发，为全球胃癌患者提供新的治疗选择。

The LATAM Investigator Meeting for the Head-to-Head Trial of HLX22 Versus Pembrolizumab Successfully Held in Brazil

Recently, Henlius successfully hosted an in-person clinical investigator meeting for the HLX22-GC-301 study in Rio de Janeiro, Brazil. The meeting focused on the international phase 3 clinical trial (HLX22-GC-301) of HLX22, our innovative anti-HER2 monoclonal antibody (mAb), in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer. The meeting brought together over 65 leading oncologists and clinical researchers from more than 35 clinical sites in Brazil, Argentina, Chile, Peru and other countries and regions. Together, they explored the clinical advantages of HLX22 as a potential Best-in-Class candidate and discussed strategies for its development in LATAM. The HLX22-GC-301 study, co-led by Dr. Lin Shen of Peking University Cancer Hospital and Dr. Jaffer A. Ajani (MD Anderson Cancer Centre; Chair of the NCCN Guidelines Panel for Gastric and Esophageal Cancers), has already been approved and initiated in China, the U.S., Japan, Australia, Argentina and other countries and regions. 

Gastric cancer is a highly prevalent malignancy in Latin America. According to the latest GLOBOCAN data, gastric cancer mortality ranked 6th among all cancer types in Latin America^[1].Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6% ^[2,3]. Despite the advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years ^[4], the disease's high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes ^[5]. Immunotherapy remains limited to PD-L1 positive populations with only modest efficacy improvements. This underscores the urgent unmet clinical needs in the overall management of HER2 positive gastric cancer.

HLX22 is a differentiated HER2-targeting monoclonal antibody that binds to a novel epitope on the HER2 extracellular domain. It can bind HER2 simultaneously with trastuzumab, effectively promoting internalization and degradation of HER2 homodimers and HER2/EGFR heterodimers. Preclinical studies demonstrated HLX22 increases HER2 internalization efficiency by 40–80%, leading to stronger HER2 blockade. Importantly, HLX22-GC-301 does not limit enrolment by PD-L1 status, aiming to overcome clinical limitations of current first-line treatment for HER2-positive gastric cancer.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,aiming to compare the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer.

Professor Lin Shen, principal investigator of the study from Peking University Cancer Hospital, said:" Henlius' HLX22 is a highly promising HER2-targeted therapy distinguished by both its mechanism of action and clinical performance. Its differentiated molecular design enables simultaneous binding to HER2 alongside trastuzumab, demonstrating exceptional antitumor efficacy. The initiation of this study in Latin America holds substantial importance in addressing the region's high incidence of gastric cancer. We will collaborate closely with all participating research centers to advance the clinical development of this therapy."

Dr. Juan Pablo Miranda Olivares of the RedSalud Cancer Institute in Chile stated: "During this investigator meeting, the interpretation of the HLX22-GC-301 study protocol and clarification of the regulatory requirements were particularly insightful, which lays a solid foundation for high-quality implementation in the following phases. We look forward to continuing our close collaboration with the Henlius team to jointly advance the progress of this study."

Dr. Manuel Philco of the Peruvian Institute of Oncology and Radiotherapy in Peru remarked: "As a key research center in the region, we have a deep understanding of the urgent needs of local gastric cancer patients. This investigator meeting has helped us clarify the critical details of the study protocol, and we are committed to promoting the smooth conduct of the clinical trial in Peru, enabling innovative therapies to benefit patients as soon as possible."

Dr. Susana Kahl of the Pergamino Research Center in Argentina noted: "The professionalism and enthusiasm demonstrated by all participating researchers were truly impressive. Through in-depth communication with the Henlius team, we gained a better understanding of the clinical value of the innovative therapy in this trial. We look forward to providing new treatment options for gastric cancer patients in Argentina and across Latin America through rigorous clinical research."

Gary Yu, Deputy General Manager of Clinical Operations at Henlius, shared the company’s broader expectations for the study: " HLX22 is a key global innovative drug project that the company is focusing on. Previously, the first patient in Latin America was administered the drug in Argentina, marking a new stage in the global clinical development of Henlius. We look forward to accelerating clinical research through close cooperation with local research institutions and bringing new treatment hope to more patients as soon as possible."

The investigator meeting facilitated in-depth discussions that further clarified patient management practices, diagnostic and treatment standards, as well as clinical trial protocol in Latin America, laying a solid foundation for the high-quality execution of the study. Looking forward, Henlius will remain committed to our mission of " To improve patients' lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence. " The company will accelerate the global clinical development of innovative therapeutics, including HLX22, to provide new treatment options for patients with gastric cancer globally.

媒体：PR@Henlius.com

投资者：IR@Henlius.com