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

2025-12-09

Henlius (2696.HK) announced today that the National Medical Products Administration (NMPA) has approved two phase 2/3 clinical trials evaluating the company’s 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.




【Reference】

  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/s12032-022-01849-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.


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.