In July 2025, Henlius celebrates the fifth anniversary of the global approval of its blockbuster breast cancer therapy, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe). As the first "China-developed" monoclonal antibody (mAb) biosimilar approved in China, the EU, and the U.S., HANQUYOU has been launched in over 50 countries and regions worldwide, with more than 7.5 million units shipped globally. Its out-licensing covers over 100 countries and regions, benefiting more than 260,000 patients worldwide. Over the past five years, Henlius has been deeply engaged in the breast cancer field—starting with HANQUYOU, the first Chinese trastuzumab biosimilar; then with HANNAIJIA (neratinib), the leader in extended adjuvant therapy; and now with an innovative pipeline covering more subtypes and treatment stages—committed to building a full-course, all-domain, global breast cancer treatment ecosystem, with the mission of "leaving no breast cancer patient behind".

China’s First Trastuzumab Biosimilar: A Benchmark Benefiting Patients Worldwide

As China’s first independently developed trastuzumab, HANQUYOU has reshaped the treatment landscape for HER2-positive breast cancer with international quality. In 2020, HANQUYOU received approvals from both the European Union and China, pioneering the internationalization of China’s biosimilars. In 2024, it successfully entered the U.S. market, becoming the first "China-developed" mAb biosimilar approved in China, the U.S., and Europe—demonstrating the global competitiveness of China’s biopharmaceutical industry. Entirely developed and manufactured by a Chinese company, this biologic not only filled the domestic gap for trastuzumab but also ushered in the era of "Trastuzumab 2.0" in China with dual dosage strengths (150mg/60mg) and preservative-free formulation for more precise and safer treatment.

HANQUYOU’s international journey has become a model for Chinese biosimilars going global. It is now approved in over 50 countries and regions, covering major markets in Europe and the U.S. as well as many emerging markets, with out-licensing agreements in over 100 countries and regions and total shipments exceeding 7.5 million units. Furthermore, HANQUYOU has been included in the national medical insurance catalogues of countries such as China, the UK, France, and Germany, ultimately benefiting over 260,000 patients with HER2-positive breast and gastric cancer worldwide. This global success is underpinned by robust clinical evidence—led by Academician Binghe Xu, the global multicenter Phase III trial HLX02-BC01 covered 89 research centers ^[1]. Its latest three-year follow-up data, published in the prestigious journal The Breast in February 2025, confirmed comparable efficacy and safety to the originator trastuzumab.

From a domestic breakthrough to a pioneer in global markets, HANQUYOU showcases Henlius' strong R&D capabilities and testifies to the rise of China's innovative biopharma industry in the global landscape. Its global commercialization journey has provided valuable experience for the internationalization of other Chinese medicines. Today, HANQUYOU stands as a benchmark for Chinese biologics going global, continually offering high-quality, affordable treatment options for breast cancer patients worldwide.

Building a Full-Course, All-Domain Breast Cancer Treatment Ecosystem: Leaving No Patient Behind

The breast cancer is the cancer with highest incidence and mortality rates among women globally. According to the data from GLOBOCAN, there were 2.3 million new cases of breast cancer worldwide and 670,000 deaths in 2022^[2]. With the mission of "leaving no breast cancer patient behind", Henlius is creating a comprehensive treatment ecosystem covering all breast cancer subtypes through independent R&D and strategic collaborations. In the HER2-positive breast cancer segment, Henlius has established a complete treatment loop from neoadjuvant to extended adjuvant therapy: HANQUYOU (trastuzumab) as the treatment cornerstone, sequentially combined with HANNAIJIA (neratinib) for extended adjuvant therapy, significantly reducing recurrence risk in early-stage patients. Meanwhile, Henlius’ pertuzumab biosimilar HLX11 has filed marketing applications with regulators in China, the U.S., and Europe and will be potentially combined with HANQUYOU for dual-target therapy to bring better outcomes for patients.

For the treatment of other subtypes, Henlius' HLX78 (lasofoxifene), an investigational novel endocrine therapy for breast cancer, completed first patient dose in China for phase 3 MRCT on ER+/HER2- breast cancer in December 2024. Notably, the company’s novel anti-HER2 antibody HLX22, in combination with trastuzumab deruxtecan(T-DXd), has entered a phase 2 clinical trial (HLX22-BC201) in HER2-low, HR-positive breast cancer, with the first patient dosed in China in April 2025—potentially addressing unmet needs in this field. Moreover, leveraging its innovative technology platforms, Henlius is actively developing more therapies for hard-to-treat subtypes, continuously enriching its treatment ecosystem to offer better options for patients globally.

In the past five years, from HANQUYOU's breakthrough in international markets to a carefully built full treatment portfolio, Henlius is writing the global story of Chinese innovative biopharma. Standing at a new starting point, Henlius embraces global collaboration with openness, responds to clinical needs with innovation, and serves patients comprehensively through an integrated ecosystem. Making every drug a beacon of hope and every treatment choice full of possibilities—this is Henlius’ best interpretation of its promise to "leave no breast cancer patient behind." On the journey to defeat breast cancer, Henlius will continue to partner with global collaborators, contributing Chinese innovation to global health and delivering high-quality treatment to every corner of the world.

References:

[1] Xu B, Zhang Q, Sun T, et a;. Efficacy, Safety, and Immunogenicity of HLX02 Compared with Reference Trastuzumab in Patients with Recurrent or Metastatic HER2-Positive Breast Cancer: A Randomized Phase III Equivalence Trial. BioDrugs. 2021 May;35(3):337-350.

[2] International Agency for Research on Cancer. Global Cancer Observatory: Cancer Today [DB/OL]. http://gco.iarc.who.int/today [2024-02-01]