復宏漢霖與Organon共同宣布歐洲首個帕妥珠單抗生物類似藥POHERDY獲歐盟委員會批準 |...

來源：市場資訊

（來源：正心谷資本）

復宏漢霖

中國上海 & 美國新澤西州澤西市，2026年4月29日 —— 復宏漢霖（2696.HK）與Organon（紐交所代碼：OGN）聯合宣布，歐盟委員會（European Commission, EC）已批準POHERDY?（帕妥珠單抗）420 mg/14 mL靜脈注射液的上市許可。該產品是歐洲首個且目前唯一獲批的PERJETA（帕妥珠單抗）生物類似藥，獲批適用于參比制劑的全部適應癥1。

Organon副總裁、全球生物類似藥商業負責人Joe Azzinaro表示：“作為歐洲首個且目前唯一獲批的帕妥珠單抗生物類似藥，POHERDY的獲批標志著在提升特定HER2陽性乳腺癌患者治療可及性方面邁出了重要一步。乳腺癌是女性中最常見的惡性腫瘤之一，也是歐盟女性癌癥相關死亡的主要原因2,3。Organon不斷豐富的生物類似藥全球產品組合，進一步彰顯了我們在支持醫療體系可持續發展的同時，持續推動女性健康、提升優質藥物可及性的堅定承諾3,4。”

復宏漢霖高級副總裁、首席商務發展官曹平表示：“繼POHERDY在美國獲批成為該市場首個帕妥珠單抗生物類似藥之后，此次在歐盟獲批進一步拓展了我們在全球市場的生物類似藥產品布局，也體現了我們與Organon穩固而富有成效的合作關系。在堅持科學嚴謹與產品質量的基礎上，我們將持續致力于為患者提供更多的治療選擇、提升可及性，造福患者并助力醫療體系的可持續發展。”

在歐洲，POHERDY適用于聯合曲妥珠單抗和多西他賽，用于治療既往未接受抗HER2治療或針對轉移性疾病化療的HER2陽性轉移性或局部復發且不可切除的乳腺癌成人患者。此外，POHERDY還可聯合曲妥珠單抗及化療用于：（i）高復發風險的HER2陽性局部晚期、炎性或早期乳腺癌成人患者的新輔助治療；（ii）高復發風險的HER2陽性早期乳腺癌成人患者的輔助治療。

POHERDY的獲批基于對一整套完整數據資料的審評，包括結構與功能分析數據、臨床藥代動力學（PK）數據以及對比性臨床研究。這些研究從整體證據（totality of evidence）出發，涵蓋分析、藥代動力學、療效、安全性及免疫原性（即生物制劑引發免疫反應的內在能力）等多個方面，充分證明POHERDY在各項關鍵指標上均與參比制劑高度相似5。

2022年，復宏漢霖與Organon達成許可與供應協議，授予Organon包括POHERDY在內的多款生物類似藥在中國以外全球范圍內的獨家商業化權利6。

關于復宏漢霖

復宏漢霖（2696.HK）是一家國際化創新生物制藥企業，致力于為全球患者提供高品質、可負擔的生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域。自2010年成立以來，公司已構建涵蓋全球研發、臨床、注冊、生產及商業化的全產業鏈平臺，擁有全球員工近4,000人，并在中國、美國和日本等多地設有運營及分支機構。依托生物類似藥形成的穩健現金流反哺創新研發，復宏漢霖正穩步邁入“全球化2.0”階段，持續打造可復制、可持續的全球增長模式。截至2026年初，公司共有10款產品在全球60余個國家和地區獲批上市，其中7款已在中國獲批。在歐美主流生物藥市場，復宏漢霖亦取得多項里程碑式突破，已有4款產品獲得美國FDA批準、5款產品獲得歐盟EC批準，充分體現了公司在研發體系、質量管理及生產能力方面已全面對標國際最高標準。

在創新驅動方面，復宏漢霖依托上海、美國等多地協同布局的研發體系，構建了多元化、平臺化的創新技術矩陣，覆蓋免疫檢查點抑制劑、免疫細胞銜接器（包括多特異性TCE）、抗體偶聯藥物（ADC）以及AI驅動的早期研發平臺等前沿方向。目前，公司擁有50余項處于早期階段的創新資產，其中約70%具備同類最佳（Best-in-Class）潛力，并在全球同步推進30余項臨床研究。核心產品H藥 漢斯狀?（斯魯利單抗，歐洲商品名：Hetronifly?）作為全球首個獲批一線治療小細胞肺癌的抗PD-1單抗，正加速全球布局，已在全球40余個市場獲批上市；同時，多款潛力創新資產，包括PD-L1 ADC HLX43及新表位HER2單抗HLX22正全面推進全球關鍵性臨床研究。依托通過中、歐、美三地GMP認證的生產體系，復宏漢霖已建成總產能達84,000升的生物藥生產平臺，形成覆蓋全球六大洲的穩定供應網絡。未來，復宏漢霖將始終堅持以患者為中心，聚焦未滿足的臨床需求，持續推動創新成果向臨床價值與患者可及轉化，在全球生物醫藥創新生態中創造長期而穩健的價值。

關于Organon

Organon（紐約證券交易所代碼：OGN）是一家全球化醫療健康公司，以提供創新性的藥品和解決方案，實現更健康的每一天為使命。Organon在全球提供超過70種藥物和醫療解決方案，并持續推動這些亟需療法在超140個市場的廣泛可及，重點業務包括女性健康與包括生物類似藥在內的經典產品，專注于為女性特有疾病、對女性影響重大或不同的疾病尋求解決方案。

Organon總部設在美國新澤西州澤西市，致力于提升醫藥健康領域的可及性、可負擔性和創新發展。訪問 www.organon.com，并關注我們的 LinkedIn、Instagram、X、YouTube、TikTok 和 Facebook以了解更多有關Organon的信息。

關于前瞻性聲明的注意事項

本新聞稿包含《1995年美國私人證券訴訟改革法案》（US Private Securities Litigation Reform Act of 1995）安全港條款所界定的“前瞻性聲明”，包括但不限于有關POHERDY的治療目標，以及Organon通過提供優質藥物、在促進女性健康的同時持續支持醫療體系可持續發展的相關承諾。前瞻性聲明通常可通過“將”、“計劃”、“持續”、“致力于支持”、“可能”等詞語及類似表達加以識別。上述聲明基于Organon管理層當前的信念和預期，受到多項重大風險和不確定性的影響。若相關假設被證明不準確，或相關風險或不確定性發生，實際結果可能與前瞻性聲明中所述存在重大差異。可能導致實際結果與前瞻性聲明存在重大差異的因素，可參見Organon向美國證券交易委員會（SEC）提交的文件，包括其最新的Form 10-K年度報告及其他相關披露文件，詳見SEC官方網站（www.sec.gov）。除非法律另有要求，Organon不承擔因新信息、未來事件或其他原因而對任何前瞻性聲明進行公開更新的義務。

PERJETA 是 F. Hoffmann-La Roche AG 在歐盟注冊的商標；Organon 與該商標所有者沒有任何關聯。

European Commission (EC) Approves Henlius and Organon’s POHERDY? (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe

SHANGHAI, China & JERSEY CITY, NJ – April 29, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY? (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1

“As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women and the leading cause of cancer related deaths among women in the European Union,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 “Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines.”3,4

“Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system.”

In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).5

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly? in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about POHERDY treatment goals and Organon’s ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicine. Forward-looking statements may be identified by words such as “will,” “plan,” “ongoing,” “commitment to supporting,” “may,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site (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.

PERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG; Organon is not associated with this trademark owner.

參考文獻

References

1. PERJETA. Product Information. Genentech, Inc.; 2025.

2. Breast cancer in the EU. European Commission, Joint Research Centre. October 2023. Accessed April 14, 2026. https://ecis.jrc.ec.europa.eu/sites/default/files/2024-01/jrc_Breast_cancer_2022_Oct_2023.pdf

3. European Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency (EMA). Last Updated October 29, 2019. Accessed April 14, 2026. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

4. Troein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; January 2025. Accessed April 14, 2026. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024.pdf

5. Biosimilar medicines: overview. European Medicines Agency (EMA). April 2, 2025. Accessed April 14, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview

6. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta ?(Pertuzumab) and Prolia ?/Xgeva ?(Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed April 14, 2026. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/