HLX22头对头国际多中心III期临床试验于欧盟获批，HER2双靶疗法一线治疗HER2阳性胃癌

迄今为止，胃癌/胃食管交界部（G/GEJ）癌依旧构成了一大全球健康问题。据GLOBOCAN数据显示，2022年全球约有100万新发病例^[1]。多数G/GEJ癌患者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]，这其中HER2 阳性患者占比约为12%-23%，且其预后较HER2阴性患者更差^[2,4]。目前，对于HER2阳性的局部晚期/转移性G/GEJ患者，其标准一线疗法为曲妥珠单抗联用化疗，针对PD-L1 阳性（PD-L1 CPS≥1）的患者，一些指南亦推荐进一步叠加联用免疫治疗，但持续疗效和预后仍有待进一步改善^[5]。

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，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，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）结果显示，在汉曲优^®联用化疗的基础上加入HLX22可提高HER2阳性G/GEJ癌患者一线治疗的生存期和抗肿瘤反应，且安全性可控^[6-8]。该研究最新结果已于2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）发布^[9]。

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联合德曲妥珠单抗二线治疗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，公司也将继续秉持以患者为中心，聚焦未满足的临床需求，积极探索优化HER2阳性肿瘤联合疗法并推进HLX22的全球开发进程，为更多患者带去福音。

Henlius Receives Clinical Approval in EU for Head-to-Head Phase 3 MRCT of Dual HER2 Blockade Therapy on First-Line HER2+ GC

Shanghai, China, April 28, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the application for clinical trial for head-to-head phase 3 international multicenter clinical study (HLX22-GC-301) of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved in Germany. Previously, the first patient was dosed in China, Japan, and Australia, and the study has obtained investigational new drug (IND) approvals in countries and regions including the United States (U.S.) and Korea. Besides, HLX22 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally.

Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million new cases in 2022 ^[1]. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6% ^[2,3]. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease used to be even worse than those with HER2-negative disease ^[2-4]. Currently, for patients with HER2-positive locally advanced/metastatic G/GEJ cancer, the current standard first-line treatment is trastuzumab plus chemotherapy. Immunotherapies are recommended to be added for tumours with PD-L1 expression levels by CPS (Combined Positive Score) of greater than 1. However, the effectiveness and prognosis for these treatments need to be further improved ^[5].

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. Results from HLX22-GC-201, a phase 2 study of HLX22 in combination with trastuzumab injection (HLX02) and XELOX, as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety ^[6-8]. Updated results were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) ^[9].

HLX22-GC-301 is a 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 gastric/gastroesophageal junction cancer. Eligible participants will be randomized at 1:1 to the experimental arm (treated with HLX22 (15 mg/kg, intravenous injection) plus 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) accessed by independent radiology review committee (IRRC) per RECIST 1.1 and overall survival (OS), the secondary endpoints include investigator-assessed PFS, IRRC or investigator-accessed objective response rate (ORR), PFS2, duration of response (DOR), quality of life, safety, immunogenicity, and pharmacokinetic characteristics.

Apart from gastric cancer, the company initiated a phase 2 clinical trial of HLX22, in combination with trastuzumab deruxtecan (T-DXd) for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer and completed the first patient dosage in China. Moving forward, the company will continue to uphold a patient-centric approach, focus on unmet medical needs, and actively explore the optimization of combination therapies for HER2-positive cancer. This includes advancing clinical development for HLX22 to bring hope to more patients around the world.

媒体：PR@Henlius.com

投资者：IR@Henlius.com