Shanghai, China, 4th December 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11, in combination with trastuzumab and chemotherapy, as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, and in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China, the United States (U.S.) and the European Union (EU). The filing was based on data from a series of head-to-head studies of HLX11 in comparison with reference pertuzumab, including analytical studies of similarities, phase 1 clinical studies and international multicenter phase 3 clinical studies. These data demonstrated that HLX11 is highly similar to the reference pertuzumab in terms of quality, safety and efficacy.
Breast cancer is the second most common tumour worldwide and the most common cancer among women globally. According to GLOBOCAN, there were 2.3 million new cases of breast cancer worldwide in 2022[1], including 357,200 new cases in China[2]. Among these, HER2-positive breast cancer accounts for approximately 20-25% of all breast cancer cases[3]. This type of tumour cells is characterised by high aggressiveness, high malignancy and rapid progression. Pertuzumab can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, pertuzumab can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Clinical studies have shown that the combination of pertuzumab and trastuzumab exhibits good synergy, significantly improving clinical efficacy and noticeably enhancing patient prognosis[4]. The dual-target therapy combining pertuzumab and trastuzumab has become a cornerstone in the treatment of HER2-positive breast cancer, recommended by guidelines at home and abroad, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines, the Guidelines for Breast Cancer Diagnosis and Treatment by China Anti-cancer Association (CACA).
Henlius has been deeply engaged in the anti-HER2 treatment field. Its comprehensive product pipeline includes multiple HER2-targeted drugs that can work synergistically to form effective treatment combinations, thereby benefiting more patients with HER2 tumours. Among them, the company’s self-developed HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) is a Chinese monoclonal antibody (mAb) biosimilar approved in China, the EU and the U.S. Up to now, it has been approved for marketing in 50 countries and regions and has been licensed out to about 100 countries and regions. The company’s newly-approved small-molecule anti-tumor drug HANNAIJIA (neratinib) has rapidly entered clinical application as a sequential therapy after completion of HANQUYOU, offering a new treatment option for patients with HER2-positive early-stage breast cancer. HLX11 also has the potential to be used in combination with HANQUYOU, further strengthening Henlius’ market position and competitiveness in the HER2 breast cancer treatment field while providing patients with more comprehensive and effective treatment options. The phase 3 international multicenter clinical trial of company’s self-developed innovative anti-HER2 mAb HLX22, has recently completed its first patient dosing in China. It is expected to further improve treatment outcomes for patients with HER2-positive gastric cancer, leading to better survival benefits.
Going forward, Henlius will remain dedicated to oncology, continuously enriching and optimising its product pipeline to offer patients a broader range of high-quality, accessible and affordable treatment options.
【Reference】
[1] https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services.
[2] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He,
Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024.
[3] Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40.
[4] Agus DB, Akita RW, Fox WD, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002; 2: 127–37