来源：市场资讯
（来源：正心谷资本）
复宏汉霖
中国上海 & 美国新泽西州泽西市，2026年4月29日 —— 复宏汉霖（2696.HK）与Organon（纽交所代码：OGN）联合宣布，欧盟委员会（European Commission, EC）已批准POHERDY®（帕妥珠单抗）420 mg/14 mL静脉注射液的上市许可。该产品是欧洲首个且目前唯一获批的PERJETA（帕妥珠单抗）生物类似药，获批适用于参比制剂的全部适应症1。
Organon副总裁、全球生物类似药商业负责人Joe Azzinaro表示：“作为欧洲首个且目前唯一获批的帕妥珠单抗生物类似药，POHERDY的获批标志着在提升特定HER2阳性乳腺癌患者治疗可及性方面迈出了重要一步。乳腺癌是女性中最常见的恶性肿瘤之一，也是欧盟女性癌症相关死亡的主要原因2,3。Organon不断丰富的生物类似药全球产品组合，进一步彰显了我们在支持医疗体系可持续发展的同时，持续推动女性健康、提升优质药物可及性的坚定承诺3,4。”
复宏汉霖高级副总裁、首席商务发展官曹平表示：“继POHERDY在美国获批成为该市场首个帕妥珠单抗生物类似药之后，此次在欧盟获批进一步拓展了我们在全球市场的生物类似药产品布局，也体现了我们与Organon稳固而富有成效的合作关系。在坚持科学严谨与产品质量的基础上，我们将持续致力于为患者提供更多的治疗选择、提升可及性，造福患者并助力医疗体系的可持续发展。”
在欧洲，POHERDY适用于联合曲妥珠单抗和多西他赛，用于治疗既往未接受抗HER2治疗或针对转移性疾病化疗的HER2阳性转移性或局部复发且不可切除的乳腺癌成人患者。此外，POHERDY还可联合曲妥珠单抗及化疗用于：（i）高复发风险的HER2阳性局部晚期、炎性或早期乳腺癌成人患者的新辅助治疗；（ii）高复发风险的HER2阳性早期乳腺癌成人患者的辅助治疗。
POHERDY的获批基于对一整套完整数据资料的审评，包括结构与功能分析数据、临床药代动力学（PK）数据以及对比性临床研究。这些研究从整体证据（totality of evidence）出发，涵盖分析、药代动力学、疗效、安全性及免疫原性（即生物制剂引发免疫反应的内在能力）等多个方面，充分证明POHERDY在各项关键指标上均与参比制剂高度相似5。
2022年，复宏汉霖与Organon达成许可与供应协议，授予Organon包括POHERDY在内的多款生物类似药在中国以外全球范围内的独家商业化权利6。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60余个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、5款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。
在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。
关于Organon
Organon（纽约证券交易所代码：OGN）是一家全球化医疗健康公司，以提供创新性的药品和解决方案，实现更健康的每一天为使命。Organon在全球提供超过70种药物和医疗解决方案，并持续推动这些亟需疗法在超140个市场的广泛可及，重点业务包括女性健康与包括生物类似药在内的经典产品，专注于为女性特有疾病、对女性影响重大或不同的疾病寻求解决方案。
Organon总部设在美国新泽西州泽西市，致力于提升医药健康领域的可及性、可负担性和创新发展。访问 www.organon.com，并关注我们的 LinkedIn、Instagram、X、YouTube、TikTok 和 Facebook以了解更多有关Organon的信息。
关于前瞻性声明的注意事项
本新闻稿包含《1995年美国私人证券诉讼改革法案》（US Private Securities Litigation Reform Act of 1995）安全港条款所界定的“前瞻性声明”，包括但不限于有关POHERDY的治疗目标，以及Organon通过提供优质药物、在促进女性健康的同时持续支持医疗体系可持续发展的相关承诺。前瞻性声明通常可通过“将”、“计划”、“持续”、“致力于支持”、“可能”等词语及类似表达加以识别。上述声明基于Organon管理层当前的信念和预期，受到多项重大风险和不确定性的影响。若相关假设被证明不准确，或相关风险或不确定性发生，实际结果可能与前瞻性声明中所述存在重大差异。可能导致实际结果与前瞻性声明存在重大差异的因素，可参见Organon向美国证券交易委员会（SEC）提交的文件，包括其最新的Form 10-K年度报告及其他相关披露文件，详见SEC官方网站（www.sec.gov）。除非法律另有要求，Organon不承担因新信息、未来事件或其他原因而对任何前瞻性声明进行公开更新的义务。
PERJETA 是 F. Hoffmann-La Roche AG 在欧盟注册的商标；Organon 与该商标所有者没有任何关联。
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.
参考文献
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/
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