In August 2026, Henlius' independently developed HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) marks the sixth anniversary of its approval in China. This core oncology product, indicated for the treatment of HER2-positive breast cancer and gastric cancer, was first approved by the European Commission (EC) on July 27, 2020, becoming the first China-developed monoclonal antibody (mAb) biosimilar to enter the EU market and marking a milestone in the globalization of China's biopharmaceutical industry. In August of that year, HANQUYOU was also approved in China, becoming the country's first independently developed trastuzumab.
Over six years of dedicated development, HANQUYOU has become a benchmark among “China-developed” mAb biosimilars, now approved in more than 50 countries and regions worldwide, including China, the EU, and the U.S., with out-licensing agreements covering over 100 countries and regions. From “China's first” to a “global benchmark,” HANQUYOU has charted an internationalization path through which China's biopharmaceutical industry has built global credibility on the strength of quality. Building on this foundation, HANQUYOU, together with HANBEIYOU (trade name in the U.S. and Europe: POHERDY®), HANNAIJIA (neratinib), and FOVINACICLIB, is jointly constructing a treatment ecosystem covering all molecular subtypes and the full course of breast cancer management—launching a new chapter in Henlius’ mission to empower patients worldwide.
International-Quality Foundation, Multiple Measures to Enhance Drug Accessibility
Backed by a robust global clinical evidence chain and a high-standard manufacturing system, HANQUYOU has earned broad recognition from regulatory agencies, clinical experts, and patients around the world. The three-year follow-up data from the global multicenter Phase 3 trial HLX02-BC01—led by Academician Binghe Xu of the Cancer Hospital, Chinese Academy of Medical Sciences and covering 89 research centers—was published in the international journal The Breast. The head-to-head equivalence study fully confirmed that HANQUYOU exhibited comparable long-term efficacy and safety to the reference trastuzumab.1 In addition, multiple real-world studies led by leading domestic institutions, including the Cancer Hospital, Chinese Academy of Medical Sciences and Peking University Cancer Hospital, have further validated its equivalence in the neoadjuvant and first-line metastatic treatment of HER2-positive breast cancer, providing ample local evidence to support standardized treatment in China.
Superior quality is the foundation, while innovative design tailored to local clinical needs is key to continuously improving the accessibility of HANQUYOU. The product pioneered a dual dosage-strength design (150mg/60mg) paired with a preservative-free formulation, breaking the long-standing limitation of imported products offering only a single strength: the 60mg strength can be flexibly combined with the 150mg strength for precise dosing, effectively minimizing drug wastage, while the preservative-free formulation reduces the risk of potential adverse reactions, offering safer treatment assurance for patients on long-term therapy.
On the manufacturing side, Henlius continuously benchmarks its entire production process against the most stringent global standards. Its commercial manufacturing system has passed GMP certification from regulatory agencies in China, the EU, the U.S., and multiple PIC/S member countries, ensuring the consistency and stability of HANQUYOU’s global supply from the source. To date, HANQUYOU has been successfully included in the national medical insurance systems of China, the UK, France, Germany, and other countries, further reinforcing international clinical confidence in the product.3
In recognition of its outstanding clinical value and innovative design, the 60mg strength of HANQUYOU was officially included in the National Essential Medicines List (2026 Edition) in July 2026.4 This follows the inclusion of trastuzumab (150mg strength) in the Essential Medicines List in 2018, further enriching and refining the dosage strengths of the drug covered under the national essential medicines system. Leveraging the expanded reach of the Essential Medicines List into grassroots healthcare institutions, HANQUYOU will extend its coverage to a broader range of primary care facilities, bringing affordable, high-quality treatment options closer to home for more female patients.
Leveraging the Core Strength of the Trastuzumab-Pertuzumab Dual-Target Regimen to Build a "Full-Course, All-domain, Global" Breast Cancer Treatment Landscape
In the core arena of HER2-positive breast cancer, the success of a single agent is only the starting point of Henlius’ broader strategy. Breast cancer is one of the most prevalent cancers among women worldwide,2 with the HER2-positive subtype accounting for approximately 20%-25% of cases. The dual-target regimen combining trastuzumab and pertuzumab has become the standard treatment option for this patient population. In May of this year, HANBEIYOU (trade name in the U.S. and Europe: POHERDY®) was officially approved by China’s NMPA, with indications covering the full scope approved for the reference pertuzumab product in China. HANBEIYOU has thus become the first “China-developed” pertuzumab approved in China, the EU, and the U.S., and the only one approved for sale overseas, joining HANQUYOU to form the first domestic trastuzumab-pertuzumab “dual-target” combination approved across China, the U.S., and the EU. In the adjuvant treatment setting, this dual-target regimen can also be sequenced with the enhanced adjuvant therapy HANNAIJIA® (Neratinib Maleate) to help reduce the risk of recurrence in early-stage patients, further completing the full treatment loop for HER2-positive breast cancer.
While consolidating its dual-target advantage, Henlius is also continuously exploring innovative breakthroughs in delivery methods and molecular formats. In April 2026, the company dosed the first subject in a clinical trial for HLX319, its independently developed fixed-dose subcutaneous formulation combining trastuzumab and pertuzumab in a single “dual-target-in-one” product—the first pertuzumab-trastuzumab subcutaneous combination biosimilar in China to advance to the clinical stage. Furthermore, at the level of deep molecular innovation, the company continues to advance a differentiated portfolio, including the novel epitope anti-HER2 monoclonal antibody HLX22 (INN: dulpatatug), the HER2-targeting ADC HLX87, and the HER2 bispecific ADC HLX49 developed on the company’s proprietary ADC platform Hanjugator™, continuously enriching diversified, cutting-edge treatment options for HER2-positive breast cancer.
In addition to HER2-positive disease, the company is simultaneously advancing its pipeline in HR-positive and triple-negative breast cancer, aiming to achieve comprehensive coverage across all molecular subtypes. In the field of HR-positive/HER2-negative breast cancer, the innovative small-molecule CDK4/6 inhibitor FOVINACICLIB has been approved in China for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer, for use in combination with an aromatase inhibitor as initial endocrine therapy, or in combination with fulvestrant for patients who have progressed following prior endocrine therapy. The product was successfully included in the National Reimbursement Drug List in 2025, substantially improving patient access. This robust commercialization is underpinned by rigorous evidence: two pivotal registrational Phase III trials were selected for presentation at this year’s ASCO Annual Meeting, with the results of the first-line metastatic Phase III trial published concurrently in the prestigious journal JAMA Oncology. In addition, the next-generation oral selective estrogen receptor modulator (SERM) lasofoxifene (HLX78) is undergoing an international multicenter Phase III trial in ESR1-mutated ER+/HER2- breast cancer, while the KAT6A/B inhibitor HLX97 is concurrently advancing through a Phase I trial, building out a comprehensive, tiered pipeline for HR-positive breast cancer treatment.
In triple-negative breast cancer (TNBC), an area of urgent clinical need, Henlius has also proactively built out a forward-looking pipeline. On one hand, the broad-spectrum anti-tumor PD-L1 ADC HLX43 has demonstrated significant anti-tumor activity in multiple preclinical models, and a Phase II proof-of-concept (POC) study in TNBC has now been initiated. On the other hand, the company is actively advancing its pembrolizumab biosimilar HLX17, for which the first subject in China has been dosed in an international multicenter Phase I trial—further strengthening the company’s product reserves in this difficult-to-treat field through both cutting-edge innovation and classic immunotherapy pathways.
Over six years of continuous progress, starting with HANQUYOU, Henlius has gradually built a full-cycle breast cancer product matrix covering the HER2-positive, HR-positive, and triple-negative subtypes, spanning neoadjuvant, adjuvant, first-line metastatic, and later-line treatment settings—charting a clear “full-course, all-domain, global” treatment landscape. Looking ahead, Henlius will remain guided by clinical needs, accelerate the clinical translation of its innovative pipeline, deepen its global commercialization strategy, and honor its commitment to “leaving no breast cancer patient behind,” bringing affordable, high-quality treatment options to more patients around the world.
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