Here is the professional English translation of the Chinese title: **Henlius’ Pertuzumab (HanbeiYou®) Receives NMPA Approval, Strengthening Breast Cancer Strategy with First China-US-EU Approved Domestic Trastuzumab-Pertuzumab Combination**

• Hanbeiyou^®, as the first and only* overseas-approved “Chinese-origin” pertuzumab, has now been approved in all three major markets: the United States, the European Union, and China.
• The combination of Hanquyou^® and Hanbeiyou^® becomes the first* domestically produced trastuzumab-pertuzumab dual-target combination approved in China, the U.S., and the EU, which is expected to significantly improve the accessibility of high-quality biologics.
• Henlius will continue to deepen its “full-course, full-region, global” breast cancer strategy, committed to “leaving no breast cancer patient behind” and reshaping the breast cancer treatment ecosystem.

ShanghaiMay 29, 2026 /PRNewswire/ — On May 29, 2026, Henlius (2696.HK) announced that the New Drug Application (NDA) for its independently developed pertuzumab (trade name: Hanbeiyou^®, U.S. and European trade name: POHERDY^®) has been approved by the National Medical Products Administration (NMPA) of China. The approval covers neoadjuvant and adjuvant treatment for HER2-positive early breast cancer, as well as treatment for metastatic breast cancer, encompassing all indications already approved in China for the original pertuzumab injection. This approval of Hanbeiyou^® in China means the product has now been fully approved in all three major markets: China, the European Union, and the United States. Together with the company’s independently developed Hanquyou^® (trastuzumab, U.S. trade name: HERCESSI^™, European trade name: Zercepac^®), it forms the first* domestically produced “trastuzumab-pertuzumab dual-target” combination approved in China, the U.S., and the EU. This key milestone further solidifies the company’s leading position in the “full-course, full-region, global” breast cancer treatment landscape.

Yu Cheng, Senior Vice President and Chief Commercial Officer of Henlius, stated: “The successful approval of Hanbeiyou^® in China is not only a major achievement for the company’s breast cancer pipeline but also means that the first domestically produced trastuzumab-pertuzumab dual-target combination approved in China, the U.S., and the EU will now fully benefit domestic patients. Adhering to our mission of ‘leaving no breast cancer patient behind,’ we will leverage the synergistic advantages of the internationally qualified ‘dual-target’ regimen of Hanbeiyou^® and Hanquyou^®, and collaborate with subsequent innovative pipeline molecules, to provide more diverse and affordable high-quality treatment options for breast cancer patients worldwide.”

The first* domestically produced pertuzumab approved in China, the U.S., and the EU

Breast cancer is the second most common cancer globally and the most frequently diagnosed cancer among women worldwide. According to GLOBOCAN data, there were 2.3 million new cases of breast cancer globally 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 cancers^[3]. This type of tumor cell is characterized by strong invasiveness, high malignancy, and rapid progression. The dual-target regimen combining pertuzumab and trastuzumab has become the cornerstone of standard treatment for HER2-positive breast cancer. Hanbeiyou^® is a pertuzumab developed by Henlius in accordance with relevant biosimilar regulations in China, the EU, and the U.S. This approval in China is primarily based on the review of a series of studies comparing Hanbeiyou^® with the original pertuzumab, including analytical similarity studies, pharmacokinetic similarity studies, and clinical comparative studies, demonstrating a high degree of similarity in quality, safety, and efficacy to the original product.

Henlius consistently adheres to the highest international standards. The company’s commercial manufacturing base and supporting quality management system have passed nearly 100 on-site inspections and audits conducted by drug regulatory authorities in China, the EU, the U.S., and several PIC/S member countries (Indonesia, Brazil), as well as international commercial partners, enabling commercial supply across Asia, Europe, North America, and South America. In 2025, the manufacturing site for Hanbeiyou^®, Songjiang Base (I), and its supporting facilities obtained EU Good Manufacturing Practice (GMP) certification and successfully passed the U.S. FDA’s Pre-license Inspection (PLI), fully demonstrating its excellent quality meeting international standards.

International quality dual-target synergy, full-course, full-region, global breast cancer coverage

In the treatment landscape for HER2-positive breast cancer, Henlius’s independently developed trastuzumab (Hanquyou^®, U.S. trade name: HERCESSI^™, European trade name: Zercepac^®) is a “Chinese-origin” monoclonal antibody biosimilar approved in China, the EU, and the U.S., and has been approved for marketing in over 50 countries and regions worldwide. With the successive approvals of Hanbeiyou^® in markets such as China, the U.S., and the EU, the trastuzumab-pertuzumab dual-target combination of Hanquyou^® and Hanbeiyou^® is expected to accelerate benefits for more HER2-positive breast cancer patients globally. Additionally, Henlius’s intensified adjuvant treatment drug for HER2-positive early breast cancer, neratinib (Hannaijia^®), can be used sequentially with Hanquyou^®, potentially further reducing the risk of recurrence in patients with HER2-positive early breast cancer. Furthermore, Henlius has also laid out plans for HLX319, the first domestically produced subcutaneous fixed-dose combination of pertuzumab and trastuzumab, with its Phase I clinical trial (HLX319-001) having completed the first patient dosing in China; as well as the neoepitope anti-HER2 monoclonal antibody HLX22 (generic name: dulpatatug*) and the HER2 ADC HLX87, comprehensively covering the full-course treatment of HER2-positive breast cancer.

Through independent R&D and strategic introductions, Henlius continues to build a comprehensive treatment ecosystem covering all subtypes of breast cancer. In the field of HR-positive breast cancer treatment, the company has laid out innovative small molecule CDK4/6 inhibitor Futuoning^® (voveciclib), novel endocrine therapy lasofoxifene tablet HLX78, and KAT6A/B inhibitor HLX97, among others. In the areas of HR-positive HER2-negative and triple-negative breast cancer, the broad-spectrum anti-tumor PD-L1 ADC drug HLX43 has shown significant anti-tumor efficacy in preclinical animal models. At the same time, Henlius is accelerating the layout of diverse high-potential innovative molecules such as the HER2 dual-epitope ADC HLX49 and the LIV-1-targeted ADC HLX41, continuously advancing clinical research on monotherapies and combination therapies covering various subtypes and stages of breast cancer, enhancing therapeutic value through pipeline synergy.

In the future, Henlius will continue to deepen its presence in the breast cancer treatment field, accelerate the commercialization of high-quality drugs, continuously improve accessibility, and strengthen the R&D layout of innovative molecules, bringing hope for treatment to more breast cancer patients with a comprehensive product matrix and global quality.

*As of the latest query results from NMPA, FDA, and EMA on May 29, 2026

About Hanbeiyou^®

Hanbeiyou^® is a pertuzumab (U.S. & European trade name: POHERDY^®) independently developed and manufactured by Henlius. The product received marketing approvals from the U.S. Food and Drug Administration (FDA) in November 2025, the European Commission (EC) in April 2026, and the China National Medical Products Administration (NMPA) in May 2026, making it a “Chinese-origin” pertuzumab approved in all three regions—China, the EU, and the U.S.—and also the first pertuzumab biosimilar approved in the U.S. and the EU. In China, the product is approved for use in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2-positive locally advanced and early breast cancer, adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, and treatment of HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy, covering all indications already approved in China for the original pertuzumab.

About Henlius

Henlius (2696.HK) is an international innovative biopharmaceutical company dedicated to providing high-quality, affordable biologics to patients worldwide, covering areas such as oncology, autoimmune diseases, and ophthalmic diseases. Since its establishment in 2010, the company has built a full-industry-chain platform covering global R&D, clinical development, registration, manufacturing, and commercialization, with nearly 4,000 employees globally and operations and branches in multiple locations including China, the U.S., and Japan. Leveraging the stable cash flow generated by biosimilars to support innovative R&D, Henlius is steadily entering the “Globalization 2.0” phase, continuously building a replicable and sustainable global growth model. As of early 2026, the company has had 10 products approved for marketing in over 60 countries and regions worldwide, 8 of which have been approved in China. In major Western biologics markets, Henlius has also achieved several milestone breakthroughs, with 4 products approved by the U.S. FDA and 5 products approved by the European Commission, fully demonstrating that the company’s R&D system, quality management, and production capabilities have comprehensively met the highest international standards.

In terms of innovation-driven development, Henlius relies on a collaborative R&D system across multiple locations including Shanghai and the U.S. to build a diversified, platform-based innovative technology matrix, covering cutting-edge directions such as immune checkpoint inhibitors, immune cell engagers (including multispecific TCEs), antibody-drug conjugates (ADCs), and AI-driven early R&D platforms. Currently, the company has over 50 early-stage innovative assets, approximately 70% of which have Best-in-Class potential, and is simultaneously advancing over 30 clinical studies globally. The core product, H drug Hansizhuang^® (serplulimab, European trade name: Hetronifly^®), as the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer, is accelerating its global expansion and has been approved for marketing in over 40 markets worldwide. Meanwhile, several potential innovative assets, including the PD-L1 ADC HLX43 and the neoepitope HER2 monoclonal antibody HLX22, are comprehensively advancing global pivotal clinical studies. Relying on a production system that has passed GMP certification in China, the EU, and the U.S., Henlius has built a biologics production platform with a total capacity of 84,000 liters, forming a stable supply network covering six continents. In the future, Henlius will always adhere to a patient-centered approach, focus on unmet clinical needs, continuously promote the transformation of innovative achievements into clinical value and patient accessibility, and create long-term, stable value in the global biomedical innovation ecosystem.

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