ShanghaiApril 29, 2026 /PRNewswire/ — Henlius (2696.HK) and Organon (NYSE: OGN) today jointly announced that the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL solution for intravenous infusion. This product is the first and currently only approved biosimilar to PERJETA (pertuzumab) in Europe, approved for all indications of the reference product[1].
Joe Azzinaro, Vice President and Head of Global Biosimilars Commercial at Organon, stated: “As the first and currently only approved pertuzumab biosimilar in Europe, the approval of POHERDY marks a significant step forward in improving access to treatment for specific patients with HER2-positive breast cancer. Breast cancer is one of the most common malignancies among women and the leading cause of cancer-related death among women in the EU[2],[3]. Organon’s expanding global portfolio of biosimilars further underscores our steadfast commitment to advancing women’s health and improving access to quality medicines while supporting the sustainability of healthcare systems[3],[4].”
Cao Ping, Senior Vice President and Chief Business Development Officer at Henlius, commented: “Following the approval of POHERDY in the U.S. as the first pertuzumab biosimilar in that market, this approval in the EU further expands our biosimilar product portfolio in the global market and reflects our solid and productive partnership with Organon. Based on scientific rigor and product quality, we will continue to provide patients with more treatment options, improve accessibility, benefit patients, and support the sustainable development of healthcare systems.”
In Europe, POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Additionally, POHERDY is indicated in combination with trastuzumab and chemotherapy for: (i) neoadjuvant treatment of adult patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence; (ii) adjuvant treatment of adult patients with HER2-positive early-stage breast cancer at high risk of recurrence.
The approval of POHERDY was based on a review of a comprehensive data package, including structural and functional analyses, clinical pharmacokinetic (PK) data, and comparative clinical studies. These studies, based on the totality of evidence covering analysis, pharmacokinetics, efficacy, safety, and immunogenicity (i.e., the inherent ability of a biologic to elicit an immune response), fully demonstrate that POHERDY is highly similar to the reference product across all key parameters[5].
In 2022, Henlius and Organon entered into a license and supply agreement, granting Organon exclusive commercialization rights for multiple biosimilars, including POHERDY, outside of China[6].
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 worldwide and operations and branches in multiple locations including China, the United States, and Japan. Leveraging a robust cash flow from 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 10 products approved for marketing in over 60 countries and regions worldwide, 7 of which have been approved in China. In major Western biologics markets, Henlius has also achieved multiple 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 leverages its collaborative R&D system across multiple locations including Shanghai and the United States 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 innovative assets in early stages, approximately 70% of which have Best-in-Class potential, and is simultaneously advancing over 30 clinical studies globally. The core product 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, multiple potential innovative assets, including the PD-L1 ADC HLX43 and the neo-epitope HER2 monoclonal antibody HLX22, are advancing global pivotal clinical studies. Relying on a production system certified under GMP standards in China, Europe, and the United States, Henlius has established 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-centric approach, focus on unmet clinical needs, continuously drive the transformation of innovation into clinical value and patient accessibility, and create long-term, stable value within the global biopharmaceutical innovation ecosystem.
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver innovative medicines and solutions for a healthier every day. Organon offers over 70 medicines and healthcare solutions worldwide and continues to promote broad access to these urgently needed therapies in over 140 markets, with key business areas including women’s health and established products, including biosimilars, focusing on solutions for diseases specific to women or that affect women differently or disproportionately.
Headquartered in Jersey City, New Jersey, USA, Organon is committed to improving accessibility, affordability, and innovation in the pharmaceutical and healthcare field. Visit www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok, and Facebook to learn more about Organon.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined by the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the therapeutic goals of POHERDY, and Organon’s commitments to supporting the sustainable development of healthcare systems while promoting women’s health through the provision of quality medicines. Forward-looking statements can often be identified by words such as “will,” “plan,” “continue,” “committed to supporting,” “may,” and similar expressions. These statements are based on the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or if risks or uncertainties materialize, actual results may differ materially from those expressed in the forward-looking statements. Factors that could cause actual results to differ materially from those expressed in forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K and other relevant disclosure documents, available on the SEC’s website (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
PERJETA is a trademark of F. Hoffmann-La Roche AG registered in the European Union; Organon is not affiliated with the trademark owner.
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1. PERJETA. Product Information. Genentech, Inc.; 2025. |