- The first and only China-developed pertuzumab approved for overseas markets, gaining approval in the three major markets of China, the U.S., and the EU
- HANQUYOU and HANBEIYOU become the first domestic trastuzumab-pertuzumab dual-target combination approved in China, the US, and the EU, expected to significantly enhance accessibility to high-quality biopharmaceutical products
- Henlius will continue to advance its comprehensive, full-course and global breast cancer strategy, driven by its commitment to leave no breast cancer patient behind and to help reshape the breast cancer treatment landscape
On May 29, 2026, Henlius (2696.HK) announced that the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY®) has been approved by the National Medical Products Administration (NMPA). It is indicated for neoadjuvant and adjuvant treatment of HER2-positive early-stage breast cancer and for the treatment of metastatic breast cancer, covering all indications approved in the Chinese Mainland for the reference pertuzumab injection. The approval signifies that the product has now been approved in the three major markets of China, the European Union, and the United States. Furthermore, Henlius' HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) and HANBEIYOU have become the first domestic trastuzumab-pertuzumab dual-target combination approved in China, the US, and the EU. This critical milestone further solidifies the company's leading position in the comprehensive, full-course and global layout in the field of breast cancer treatment.
Henlius Senior Vice President and Chief Commercial Officer Kurt Yu stated: "The successful approval of HANBEIYOU in China is not only another significant achievement in the company's breast cancer pipeline but also signifies that the first domestically developed dual-target combination of Trastuzumab and Pertuzumab approved in China, the U.S., and Europe will comprehensively benefit domestic patients. Adhering to the mission of 'leaving no breast cancer patient behind,' we will leverage the synergistic advantages of the internationally high-quality dual-target regimen of HANBEIYOU and HANQUYOU, and collaborate with subsequent diverse innovative pipeline molecules to provide more diverse, affordable, and high-quality therapeutic options for breast cancer patients worldwide.
The First China-Developed Pertuzumab Approved in China, the US, and the EU
Breast cancer is the second most common tumor globally and the most prevalent cancer among women. According to GLOBOCAN data, there were 2.3 million new breast cancer cases worldwide in 2022,1 with 357,200 new cases in China.2 Among these, HER2-positive breast cancer accounts for approximately 20%-25% of all breast cancer cases,3 characterized by aggressive tumor cells, high malignancy, and rapid progression. The dual-target regimen combining pertuzumab and trastuzumab has become the cornerstone of HER2-positive breast cancer treatment.
HANBEIYOU is a pertuzumab biosimilar independently developed by Henlius in compliance with biosimilar regulations in China, the EU, and the US. Its approval in China is primarily based on a comprehensive review of a series of comparative study data between HANBEIYOU and reference pertuzumab, including analytical similarity study, pharmacokinetic similarity study and comparative clinical study. These study data have demonstrated that HANBEIYOU is highly similar to the reference pertuzumab in terms of quality, safety and efficacy.
As the first and only China-developed pertuzumab approved in overseas market, HANBEIYOU was approved by the US Food and Drug Administration (FDA) in November 2025 and is interchangeable with the reference product PERJETA (pertuzumab). It is also the only China-developed pertuzumab with clinical evidence of interchangeability with the reference product. Subsequently, the drug was approved by the European Commission (EC) in April 2026, becoming the first and only PERJETA biosimilar in the US and EU. Data from its pivotal Phase 3 equivalence trial (NCT05346224) were also selected for a mini oral presentation at the 2025 ESMO Congress. International regulatory approval and recognition by authoritative academic conferences have fully validated the global quality of the product.
Henlius adheres to the highest international standards, with its commercial manufacturing facilities and quality management system passing nearly 100 on-site inspections and audits conducted by regulatory agencies and international commercial partners from China, the EU, the US, and multiple PIC/S member countries (e.g., Indonesia, Brazil). The company has achieved commercial supply capabilities in regions including Asia, Europe, North America, and South America. In 2025, the manufacturing site and facilities for HANBEIYOU received EU Good Manufacturing Practice (GMP) certification, successfully passed the FDA's Pre-license Inspection (PLI), fully demonstrating its exceptional quality in compliance with international standards.
Comprehensive Breast Cancer Coverage with International Quality Dual-Target Synergy
In the HER2-positive breast cancer treatment landscape, Henlius' independently developed trastuzumab HANQUYOU is a China-developed monoclonal antibody biosimilar approved in China, the EU, and the US, and has been approved in over 50 countries and regions worldwide. With the approval of HANBEIYOU in China, Europe and the United States, the dual-target combination of HANQUYOU and HANBEIYOU, is expected to accelerate benefits for more HER2-positive breast cancer patients globally.
Additionally, Henlius' neratinib HANNAIJIA for enhanced adjuvant treatment of HER2-positive early-stage breast cancer can be used sequentially with HANQUYOU, potentially further reducing the risk of recurrence in HER2-positive early-stage breast cancer patients. Henlius is also developing HLX319, the first domestic fixed-dose subcutaneous injection of pertuzumab and trastuzumab, which has completed its first subject dosing in a Phase 1 clinical trial (HLX319-001) in China. Furthermore, the company is advancing innovative HER2-targeting therapies, including the novel epitope anti-HER2 monoclonal antibody HLX22 (dulpatatug*), HER2 ADC HLX87, and others, to comprehensively cover the full course of HER2-positive breast cancer treatment.
Through independent research and strategic partnerships, Henlius continues to build a complete treatment ecosystem covering all subtypes of breast cancer. In the HR-positive breast cancer treatment field, the company is developing innovative small-molecule CDK4/6 inhibitor FUTUONING (fulvestrant), novel endocrine therapy lasofoxifene tablets HLX78, and KAT6A/B inhibitor HLX97. In the HR+/HER2- and triple-negative breast cancer domains, Henlius' independently developed PD-L1 ADC drug HLX43 has demonstrated anti-tumor efficacy in preclinical studies using animal models. The company is also advancing the development of LIV-1-targeting ADC HLX41 and HER2xHER2 bispecific ADC HLX49, among other high-potential innovative molecules, to drive clinical research on monotherapy and combination therapy across different breast cancer subtypes and stages, enhancing therapeutic value through pipeline synergy.
Looking ahead, Henlius will continue to focus on the breast cancer treatment field, accelerating the commercialization of high-quality drugs to improve accessibility, while strengthening the development of innovative molecules. With a comprehensive product portfolio and global quality standards, Henlius aims to bring hope to more breast cancer patients.
*As of May 29, 2026, based on the latest search results from the NMPA, FDA, and EMA.
About HANBEIYOU
HANBEIYOU (pertuzumab, trade name in US and Europe: POHERDY®), independently developed and manufactured by Henlius, has been approved for marketing successively by the US Food and Drug Administration (FDA), the European Commission (EC), and the China National Medical Products Administration (NMPA) in November 2025, April 2026, and May 2026, respectively, making it a China-developed pertuzumab approved in China, the European Union, and the United States. It is also the first pertuzumab biosimilar approved in the US and EU. The product is approved in China for use in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2-positive locally advanced and early breast cancer, as well as adjuvant treatment for HER2-positive early breast cancer at high recurrence risk. It is also indicated for HER2-positive metastatic breast cancer in patients with no prior anti-HER2 therapy. This covers all approved indications of the reference pertuzumab injection in Chinese mainland.
References
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.