复星医药子公司复宏汉霖帕妥珠单抗生物类似药HLX11获欧洲药品管理局人用药品委员会积极意见
中国上海，2026年2月27日 —— 复星医药子公司复宏汉霖（2696.HK）宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已发布积极意见，推荐公司参照原研药Perjeta®（帕妥珠单抗）自主开发的在研生物类似药HLX11（美国商品名：POHERDY®）获得上市许可，建议批准其用于原研产品在欧盟已获批的全部适应症，涵盖HER2阳性早期及转移性乳腺癌。此次CHMP的积极意见是HLX11在欧洲的一项重要监管里程碑，并在获得欧盟委员会批准的前提下，有望推动该产品未来在欧洲地区惠及更多患者。
复宏汉霖首席商务发展官兼高级副总裁
曹平女士表示
HLX11获得CHMP积极意见，是复宏汉霖全球化战略的又一重要进展。这不仅彰显了公司在国际注册和全球质量体系的深厚积淀，也体现我们跨区域商业化协作方面的综合实力。我们将继续与合作伙伴Organon紧密协作，提升高品质生物药在欧洲市场的可及性，为患者提供兼具品质与可负担性的治疗选择。
HLX11是一款拟用于与曲妥珠单抗及化疗联合使用的生物类似药候选产品，适用于：（i）作为新辅助治疗，用于治疗具有高复发风险的HER2阳性局部晚期、炎性或早期乳腺癌成人患者；以及（ii）作为辅助治疗，用于治疗具有高复发风险的HER2阳性早期乳腺癌成人患者。
此外，HLX11还拟与曲妥珠单抗及多西他赛联合使用，用于治疗HER2阳性转移性或局部复发且不可切除的、此前未接受过针对其转移性疾病的抗HER2治疗或化疗的乳腺癌成人患者。
HLX11是复宏汉霖在HER2靶向治疗领域布局的重要生物类似药产品。此次CHMP积极意见主要是基于对HLX11一系列研究数据的审查，包括分析相似性研究及临床比对研究，证明了其与原研产品在质量、安全性和有效性方面的相似。此前，该产品已在美国获批上市，并被认定为可互换（interchangeable）生物类似药，其在加拿大的上市申请也已获得Health Canada的受理。此次获得CHMP积极意见，进一步体现了国际主流监管机构对HLX11的认可。
根据欧盟法规，CHMP的积极意见将提交至欧盟委员会进行最终审议。若获欧盟委员会批准，HLX11将可在欧盟成员国及欧洲经济区国家上市。复宏汉霖于2022年与Organon达成授权许可和供应合作，授予其对包括HLX11在内的两款在研生物类似药在除中国以外的全球区域进行独家商业化的权益。
未来，复宏汉霖将持续以高质量标准推进全球化布局，携手合作伙伴加快后续注册和商业化进程，造福更多患者，进一步巩固公司在全球生物制药领域的综合竞争力和品牌影响力。
*POHERDY®为N.V. Organon在美国注册的商标。
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、4款产品获得欧盟EMA上市授权，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。
EMA CHMP Recommends EU Approval of Henlius’ Pertuzumab Biosimilar HLX11
Shanghai, China, February 27, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for HLX11 (trade name in U.S.: POHERDY), a biosimilar candidate to Perjeta® (pertuzumab) independently developed by Henlius. The positive opinion recommends approval of HLX11 for all indications approved for the reference product in the European Union, covering HER2-positive early and metastatic breast cancer.
The positive CHMP opinion marks a significant regulatory milestone for HLX11 in Europe and supports the potential future availability of the products to patients across the region, subject to European Commission approval.
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, said: “The positive CHMP opinion for HLX11 represents another important advancement in Henlius’ global strategy. It not only underscores our strong capabilities in international regulatory submissions and global quality systems, but also demonstrates our strength in cross-regional commercialization collaboration. We will continue to work closely with our partner Organon to enhance access to high-quality biologics in the European market and provide patients with treatment options that combine quality and affordability.”
HLX11 is a biosimilar candidate intended for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence; and (ii) adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. HLX11 also has a proposed indication for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
HLX11 is a key biosimilar product in Henlius’ HER2-targeted therapy portfolio. The CHMP positive opinion was primarily based on a comprehensive review of analytical similarity studies and clinical comparative studies, which demonstrated similarity to the reference product in terms of quality, safety, and efficacy.
HLX11 has previously been approved in the United States, where it was also designated as an interchangeable biosimilar. Its marketing authorization application in Canada has been accepted for review by Health Canada. The CHMP positive opinion further confirms recognition by major international regulatory authorities of HLX11.
Under EU regulatory procedures, the CHMP’s positive opinion will be submitted to the European Commission (EC) for final decision. If approved by the European Commission, HLX11 will be authorized for marketing in all EU Member States and European Economic Area (EEA) countries.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to multiple biosimilars, including HLX11. The agreement covers exclusive global commercialization rights except for China.
Looking ahead, Henlius will continue to uphold high standards to advance its global footprint, work closely with partners to accelerate registrations and commercialisation, benefit more patients, and further strengthen the company's competitiveness and brand influence in the global biopharmaceutical industry.
POHERDY® is a trademark registered in the U.S. in the name of N.V. Organon.
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 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 four products authorized by the European Medicines Agency (EMA), 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/ and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
