复宏汉霖HLX22用于HER2阳性乳腺癌新辅助及一线治疗的II/III期临床研究...

今日，复宏汉霖（2696.HK）宣布，公司自主研发的新表位HER2单克隆抗体HLX22，联合创新抗HER2抗体偶联药物（ADC）HLX87，用于新辅助及一线治疗HER2阳性乳腺癌的两项II/III期临床研究已获国家药品监督管理局（NMPA）批准开展。这一进展标志着复宏汉霖在乳腺癌治疗领域的创新探索迈出了重要一步。

2022年全球肿瘤流行病统计数据（GLOBOCAN）显示，乳腺癌已成为女性中最常见的癌症（发病率和死亡率）1。HER2是乳腺癌治疗最重要的靶标之一，大约15～20%的乳腺癌存在HER2过表达，HER2阳性乳腺癌具有高度侵袭性和高复发率2,3。随着抗HER2治疗手段的不断发展，曲妥珠单抗、帕妥珠单抗及靶向HER2的ADC等药物已逐渐成为HER2阳性乳腺癌的重要治疗策略。

过去二十年来，HER2靶向治疗虽显著改善了临床结局4，但在HER2阳性早期乳腺癌的新辅助治疗中，标准方案通常为HER2靶向药联合4–5种化疗药物，短期和长期毒性显著，且仍有相当比例患者复发甚至死亡5,6。此外，HER2阳性转移性乳腺癌（mBC）患者最终仍会因耐药而出现疾病进展。目前，一线标准方案为HER2靶向治疗联合化疗，但化疗及HER2靶向药均存在各自的安全风险7,8。因此，临床对更高效、更安全、“免化疗”的新型HER2治疗策略的需求日益迫切。

HLX22为靶向HER2的新表位单克隆抗体，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，能通过与曲妥珠单抗“非重叠表位协同结合”，放大HER2内吞和降解作用。HLX22联合德曲妥珠单抗的动物实验结果以及同类临床研究的数据显示，HER2单抗联合HER2 ADC的治疗策略具有协同抗肿瘤作用，且整体安全性良好。基于以上背景，复宏汉霖进一步探索HLX22与其它抗肿瘤药物的联合治疗方案，针对胃癌、乳腺癌等实体瘤开展临床研究，旨在为患者提供协同作用更强、毒性更可控的新治疗选择。除本次获批的两项临床研究外，复宏汉霖2025年亦启动一项HLX22联合标准治疗或德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究（HLX22-BC201），并于中国境内完成首例患者给药，有望为不同治疗阶段的乳腺癌患者提供新的临床选择。

复宏汉霖深耕乳腺癌治疗领域，通过自主研发与合作引进，已建立覆盖乳腺癌全程全域治疗管线。公司乳腺癌核心产品曲妥珠单抗汉曲优（美国商品名：HERCESSI，欧洲商品名：Zercepac）已在全球50多个国家和地区获批上市；HER2阳性乳腺癌早期强化辅助治疗药物汉奈佳（奈拉替尼）与汉曲优续贯协同，降低复发风险；帕妥珠单抗POHERDY为美国首款且唯一的PERJETA生物类似药，并同步推进中国、欧洲与加拿大的上市申请，有望与汉曲优联用实现双靶协同增效；创新CDK4/6抑制剂复妥宁已在中国获批用于晚期HR+/HER2-乳腺癌的一线和二线治疗。同时，复宏汉霖加速布局新表位抗HER2单抗HLX22、新型内分泌疗法拉索昔芬片HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2 ADC HLX87等多元类型高潜创新分子。未来，公司将持续强化管线协同，构建贯穿全病程的诊疗生态，为更多乳腺癌患者提供全面的解决方案。

【参考文献】

1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751.

2. Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med. 2014;138(2):241-256. doi:10.5858/arpa.2013-0953-SA.

3. Dean-Colomb W, Esteva FJ. Her2-positive breast cancer: herceptin and beyond. Eur J Cancer. 2008;44(18):2806-2812. doi:10.1016/j.ejca.2008.09.013.

4. Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372(8):724-34.

5. Dawood S, Broglio K, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutionalbased review. J Clin Oncol. 2010;28(1):92-98. doi:10.1200/JCO.2008.19.9844

6. Gupta R, Gupta S, Antonios B, et al. Therapeutic landscape of advanced HER2-positive breast cancer in 2022. Med Oncol. 2022;39(12):258. Published 2022 Oct 12. doi:10.1007/s129-y.

7. Loibl S, Gianni L. HER2-positive breast cancer. Lancet 2017;389(10087):2415-29.

8. Li H, Fu W, Gao X, Xu Q, Wu H, Tan W. Risk of severe diarrhea with dual anti-HER2 therapies: a meta-analysis. Tumour Biol 2014;35(5):4077-85.

关于HLX22

HLX22为靶向HER2的新表位单克隆抗体，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，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。除胃癌外，复宏汉霖2025年亦启动一项HLX22联合标准治疗或德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究（HLX22-BC201），并于中国境内完成首例患者给药。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，4个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）、自主研发的中美欧三地获批单抗生物类似药汉曲优（曲妥珠单抗，美国商品名：HERCESSI，欧洲商品名：Zercepac）、国内首个生物类似药汉利康（利妥昔单抗）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius Receives NMPA Approval to Initiate Phase 2/3 Clinical Trials of HLX22 for Neoadjuvant and First-Line Treatment of HER2-Positive Breast Cancer

Henlius (2696.HK) announced today that the National Medical Products Administration (NMPA) has approved two phase 2/3 clinical trials evaluating the company’s self-developed novel-epitope HER2 monoclonal antibody HLX22 in combination with its innovative anti-HER2 antibody–drug conjugate (ADC) HLX87 for the neoadjuvant and first-line treatment of HER2-positive breast cancer. This milestone marks an important step forward in Henlius’ innovative efforts in breast cancer therapy.

According to the 2022 GLOBOCAN global cancer statistics, breast cancer remains the most commonly diagnosed cancer and the leading cause of cancer death among women worldwide.1 HER2 is one of the most critical therapeutic targets in breast cancer, with approximately 15–20% of patients exhibiting HER2 overexpression—an aggressive subtype associated with high recurrence rates.2,3

Over the past two decades, HER2-targeted therapies have significantly improved patient outcomes.4 However, in early-stage HER2-positive breast cancer, standard neoadjuvant therapy typically involves HER2-targeted agents combined with 4–5 chemotherapies, resulting in substantial short- and long-term toxicities, while recurrence and mortality rates remain considerable.5,6 In addition, patients with HER2-positive metastatic breast cancer (mBC) eventually develop resistance, leading to disease progression. In the metastatic first-line setting, standard regimens rely on HER2-targeted therapy plus chemotherapy, which brings adverse event affecting adherence and outcomes.7,8 The clinical demand for more effective, safer, and chemotherapy-free HER2 treatment strategies is therefore increasingly urgent.

HLX22 is a novel-epitope monoclonal antibody targeting HER2 that binds to subdomain 4 of the HER2 extracellular region at a distinct epitope from trastuzumab. This allows HLX22 to synergistically bind with trastuzumab at non-overlapping epitopes, enhancing HER2 internalization and degradation. Animal studies of HLX22 plus trastuzumab deruxtecan (T-DXd) and data from similar clinical combinations further suggest that combining a HER2 monoclonal antibody with a HER2 ADC may yield synergistic antitumour effects with manageable toxicity. Building on this background, Henlius is further exploring combination regimens of HLX22 with other anti-tumour therapies across solid tumours such as gastric and breast cancer, with the aim of providing patients with new treatment options that offer enhanced synergistic activity and improved toxicity manageability. In addition to the newly approved phase 2/3 studies, Henlius also initiated a phase 2 clinical trial in 2025 evaluating HLX22 in combination with standard of care or trastuzumab deruxtecan (T-DXd) for patients with HER2-low, HR-positive locally advanced or metastatic breast cancer (HLX22-BC201), with the first patient in China already dosed, and is expected to offer new treatment options across disease stages for patients with breast cancer.

Henlius has built a comprehensive pipeline covering the full continuum of breast cancer care through internal innovation and strategic collaborations. Its core product, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), has been approved in more than 50 countries and regions worldwide. HANNAIJIA (neratinib) can be used sequentially after HANQUYOU to reduce the risk of recurrence for patients with early-stage HER2-positive breast cancer. POHERDY (pertuzumab), the first—and only—FDA-approved PERJETA biosimilar in the U.S., is currently under review in China, the EU and Canada, and may be used in combination with HANQUYOU for dual HER2 blockade. Henlius’ innovative CDK4/6 inhibitor FUTUONING (fovinaciclib) has been approved in China for first- and second-line treatment of HR+/HER2- advanced breast cancer. Meanwhile, Henlius is accelerating development of multiple high-potential innovative assets, including novel-epitope HER2 antibody HLX22, endocrine therapy candidate lasofoxifene HLX78, KAT6A/B inhibitor HLX97, LIV-1-targeting ADC HLX41, HER2×HER2 biparatopic ADC HLX49, and HER2 ADC HLX87. The company aims to strengthen its synergistic pipeline and build an end-to-end therapeutic ecosystem covering the entire disease course, bringing comprehensive solutions to breast cancer patients worldwide.

About HLX22

HLX22 is a novel-epitope monoclonal antibody targeting HER2. It binds to subdomain 4 of the HER2 extracellular region at an epitope distinct from that of trastuzumab, enabling simultaneous binding of HLX22 and trastuzumab to the HER2 receptor. This dual, non-overlapping epitope engagement effectively promotes the internalization and degradation of HER2 dimers (including HER2 homodimers and HER2/EGFR heterodimers), increasing HER2 internalization efficiency by 40%–80% and thereby achieving a more potent HER2 receptor blockade. Updated results from the phase 2 clinical trial of HLX22 in combination with HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) for HER2-positive gastric cancer (HLX22-GC-201) were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The data showed that, after long-term follow-up (median follow-up exceeding two years), HLX22 continued to deliver durable clinical benefits in HER2-positive gastric cancer, significantly outperforming historical benchmarks. Beyond gastric cancer, Henlius also initiated a phase 2 clinical trial in 2025 evaluating HLX22 in combination with standard of care or trastuzumab deruxtecan (T-DXd) for patients with HER2-low, HR-positive locally advanced or metastatic breast cancer (HLX22-BC201), with the first patient in China already dosed.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 10 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

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(复宏汉霖)