挑战全球一线治疗，复宏汉霖HLX22头对头III期临床美国首例患者给药

HLX22-GC-301由北京大学肿瘤医院沈琳教授与NCCN胃癌与食管癌专委会主席，MD安德森癌症中心的Jaffer A. Ajan教授牵头开展，此前已于中国、日本、澳大利亚、韩国完成首例受试者给药，并已在智利、巴西、阿根廷等国家和地区获得临床试验开展许可。此外，HLX22已于2025年获得美国食品药品监督管理局（FDA）和欧盟委员会（EC）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。

据GLOBOCAN数据显示，2022年全球约有100万胃癌新发病例，逾66万死亡病例，疾病负担呈现显著地域不平衡^[1]，构成了一大健康问题。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联合汉曲优^®（曲妥珠单抗，美国商品名：HERCESSI^™️，欧洲商品名：Zercepac^®）治疗HER2阳性胃癌II期临床研究（HLX22-GC-201）更新结果于2025年美国临床肿瘤学会（ASCO）发布^[6]，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。

HLX22-GC-301临床研究是一项双盲、国际多中心随机对照III期研究，旨在比较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癌/胃食管结合部癌患者的疗效和安全性。符合条件的受试者将以1:1的比例随机分配至试验组（接受HLX22（15 mg/kg）联合曲妥珠单抗和化疗）或对照组（接受安慰剂联合曲妥珠单抗和化疗，联合或不联合帕博利珠单抗）。该研究的主要终点为独立影像评估委员会（IRRC）基于RECIST v1.1评估的无进展生存期（PFS）和总生存期（OS）。次要终点包括研究者评估的PFS、IRRC或研究者评估的客观缓解率（ORR）、下一线治疗的PFS2、缓解持续时间（DOR）、生活质量、安全性、免疫原性和药代动力学特征。

除胃癌外，复宏汉霖近期亦启动一项HLX22联合德曲妥珠单抗治疗HER2低表达HR阳性乳腺癌的II期临床研究（HLX22-BC201）并于中国境内完成首例患者给药。未来，复宏汉霖也将持续探索新型抗HER2靶向疗法在肿瘤中的治疗潜力，高效推进HLX22的全球临床开发进展，为全球患者提供更多可负担、疗效更好的治疗方案。

Henlius’ HLX22 International Multicentre Phase 3 Head-to-Head Trial Administers First Dose to US Patient in HER2+ GC

Shanghai, China, July 14, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the United States has been dosed in the company’s international multicentre phase 3 head-to-head clinical trial (HLX22-GC-301) comparing its novel anti-HER2 monoclonal antibody (mAb) HLX22 in combination with trastuzumab and chemotherapy with the current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) as the first-line treatment for HER2-positive advanced gastric cancer. As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally.

The study is co-led by Prof. Lin Shen from Peking University Cancer Hospital and Professor Jaffer A. Ajani (MD Anderson Cancer Center; Chair of the NCCN Guidelines Panel for Gastric and Esophageal Cancers), and has previously dosed first patients in China, Japan, Australia, and South Korea, with investigational new drug (IND) approvals obtained in Chile, Brazil, Argentina and other countries and regions. HLX22 has been granted Orphan Drug Designation (ODD) by both the US Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of gastric cancer. 

Until now, gastric cancer still constitutes a major global health problem. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally ^[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, 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. Updated results from a phase 2 study (HLX22-GC-201) of HLX22 in combination with HANQUYOU (trastuzumab, trade name: HERCESSI^™ in the U.S., Zercepac^® in Europe) and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at ASCO 2025 ^[6]. The data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up (median follow-up exceeding two years), outperforming previous data.

This double-blind, randomized, controlled multicenter phase 3 study aims to compare the efficacy and safety of HLX22 in combination with Trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab as first-line treatment in patients with HER2-positive, locally advanced or metastatic gastroesophageal junction cancer and gastric cancer. Eligible participants will be randomized at 1:1 to the experimental arm (treated with HLX22 (15 mg/kg) in combination with Trastuzumab and chemotherapy) or the control group (placebo plus Trastuzumab and chemotherapy with or without pembrolizumab). The primary endpoints of this study are progression-free survival (PFS) assessed by independent radiology review committee (IRRC) per RECIST v1.1 and overall survival (OS), the secondary endpoints include investigator-assessed PFS, IRRC or investigator-assessed objective response rate (ORR), PFS2, duration of response (DOR), quality of life, safety, immunogenicity and pharmacokinetic characteristics.

Beyond gastric cancer, Henlius has also recently initiated a phase 2 clinical trial (HLX22-BC201) of HLX22 in combination with trastuzumab deruxtecan (T-DXd) as second-line therapy for HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer and has dosed the first patient in China. Moving forward, Henlius will continue to explore the therapeutic potential of novel HER2-targeted therapies in tumours, accelerating HLX22’s global development to deliver more affordable and effective treatment options for patients worldwide.

媒体：PR@Henlius.com

投资者：IR@Henlius.com