复星医药子公司复宏汉霖与Organon共同宣布美国首个帕妥珠单抗生物类似药POHERDY获美国FDA批准

Source

（来源：复星医药）

转自：复星医药

中国上海 & 美国新泽西州泽西市，2025年11月17日 —— 复星医药子公司复宏汉霖（2696.HK）与Organon（纽交所代码：OGN）今日共同宣布，帕妥珠单抗注射液（420 mg/14 mL）POHERDY®（pertuzumab-dpzb）生物制品许可申请（BLA）获美国食品药品监督管理局（FDA）批准，并可与原研产品PERJETA（pertuzumab）互换使用，成为美国首款且唯一的PERJETA生物类似药，覆盖其在美国已获批的所有适应症1, 2。这一获批标志着在提升特定HER2阳性乳腺癌患者获得兼具品质与潜在更可负担治疗的可及性方面迈出了具有里程碑意义的一步。

Organon生物类似药和成熟药业务美国商业主管Jon Martin

表示：“提升女性高发疾病的治疗可及性，包括乳腺癌这一美国女性最常见的癌症（不含皮肤癌）3，是我们始终坚守的核心使命。POHERDY®不仅是首个在美获批的PERJETA生物类似药，它的获批也延续了Organon近来在女性健康与肿瘤领域不断丰富生物类似药管线的良好势头。我们与复宏汉霖的紧密合作，对于实现我们为美国患者打造更可持续医疗体系的目标至关重要。”

复宏汉霖执行董事、首席执行官

朱俊博士表示

POHERDY®的获批代表复宏汉霖在生物药领域全球布局和质量开发方面实现了又一次具有里程碑意义的突破。作为美国首个获批的帕妥珠单抗生物类似药2，这一重要成果展现了我们以严谨的科学和监管标准构建可持续全球研发体系的核心能力，也印证了复宏汉霖秉持‘以患者为中心’的核心理念，坚定推进全球化战略的长期承诺。我们将加速推动具有品质的生物药惠及全球更多患者，为人类健康事业创造更大价值。

复宏汉霖首席商务发展官兼高级副总裁

曹平表示

POHERDY®的获批进一步体现了公司在国际注册方面的良好成绩，以及我们在质量管理和商业化协作方面的综合实力。我们期待与合作伙伴Organon紧密协作，充分发挥双方在供应链、市场与渠道方面的协同优势，共同提升高品质生物药的可及性，为更多患者提供兼具品质与经济性的治疗选择。

帕妥珠单抗是一种针对HER2受体的单克隆抗体，是HER2阳性乳腺癌治疗的重要组成部分，适用于：转移性乳腺癌，即与曲妥珠单抗和多西他赛联合，治疗既往未接受过转移性乳腺癌抗HER2治疗或化疗的HER2阳性、转移性乳腺癌患者；以及早期乳腺癌，即与曲妥珠单抗和化疗联合，作为早期乳腺癌整体治疗方案的一部分，用于HER2阳性、局部晚期、炎性或早期乳腺癌患者（直径＞2cm或淋巴结阳性）的新辅助治疗，以及用于具有高复发风险HER2阳性早期乳腺癌患者的辅助治疗。完整适应症见文末。

帕妥珠单抗可导致亚临床和临床心力衰竭，表现为左心室射血分数（LVEF）下降及充血性心力衰竭（CHF）。治疗前和治疗期间需要评估患者的心脏功能。如果确认发生具有临床意义的左心室功能下降，应停止POHERDY治疗。暴露帕妥珠单抗可导致胚胎-胎儿死亡和出生缺陷。应向患者告知这些风险并在用药时采取有效的避孕措施。更多安全性信息见文末。

此次FDA的批准主要是基于一整套全面数据的审查，包括分析相似性研究、临床药代动力学研究及临床比对研究。研究表明，POHERDY®在安全性、纯度和效力方面（即安全性和有效性）与原研产品PERJETA高度相似，并可实现互换使用4,5。

2022年，复宏汉霖与 Organon 签订许可与供应协议，授予 Organon 对包括POHERDY®在内的多个生物类似药在除中国以外的全球区域的独家商业化权益6。POHERDY®在美国的获批，将进一步丰富双方在肿瘤领域的产品组合并助力将具有品质的生物药带给更多患者。

PERJETA为基因泰克公司（Genentech, Inc.）在美国注册的商标；Organon与该商标持有人不存在任何关联。

【参考文献】

  1. PERJETA. Prescribing Information. Genentech Inc.; 2025.

  2. Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed November 10, 2025. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals

  3. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

  4. Review and approval. U.S. Food and Drug Administration. December 13, 2022. Accessed July 28, 2025. https://www.fda.gov/drugs/biosimilars/review-and-approval

  5. Biosimilar product regulatory review and approval. U.S. Food and Drug Administration. Accessed May 1, 2025. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf

  6. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed July 28, 2025. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，3个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、地舒单抗生物类似药Bildyos®和Bilprevda®，以及帕妥珠单抗POHERDY®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

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、经典产品和生物类似药，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

除历史信息外，本新闻稿包含的某些陈述和披露属于1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性陈述”，包括但不限于有关扩大HER2阳性乳腺癌患者治疗可及性、POHERDY的潜在市场机会、Organon生物类似药产品组合的扩展、Organon与复宏汉霖的合作，以及复宏汉霖的全球布局和生物药研发的相关表述。前瞻性陈述通常可通过以下词语识别： “目标”“、继续”、“向前”、“愿景”、“使命”、“预期”、“探索”、“未来”、“相信”、“将”、“潜在”等类似表达。这些前瞻性陈述基于公司管理层当前的信念和预期，但同时受到重大风险和不确定性的影响。如果基础假设不准确或风险/不确定性事项发生，实际结果可能与这些前瞻性声明中所述存在重大差异。风险和不确定性因素包括但不限于：无法在欧洲上市HLX11（Perjeta®（帕妥珠单抗）在研生物类似药）；Organon所在市场的品牌与品类竞争加剧；贸易保护措施、进出口许可要求，以及美国或其他政府实施的关税（包括可能的医药行业关税）、贸易制裁或类似限制措施的直接或间接影响；美国及其他国家/地区政府各级财政预算分配的变化，包括分配给Organon客户或业务合作伙伴的时间及金额；Organon无法控制的宏观经济因素，如通胀、利率变化、经济衰退压力及外汇波动；Organon依赖的第三方未能按预期履行职责导致业务增长受阻；供应商未能按照约定提供原料、材料或服务，或未能履行相关义务；供应、生产、包装及运营成本上升；与商业合作伙伴建立或维持合作关系的困难；全球范围内的价格压力，包括由医疗保险管理组织、司法判决及政府法律法规（涉及或影响医保、医疗改革、药品定价、报销、准入制度、国际参考定价（包括“最低优惠国家”规则）及其他定价政策）所带来的影响；Organon未能全面落实产品开发与商业化计划；生产困难或延迟；美国FDA、美国证券交易委员会（SEC）及其他美国或海外监管机构的运作中断；美国及其他司法辖区内法律法规的变动，包括与产品研发、审批、注册、生产、供应、分销和/或营销相关的法规及知识产权和环境保护法规的变化及其执法力度；产品出现或被认为出现疗效、安全性或其他质量问题（无论是否有科学依据），导致产品召回、退市、标签变更或销售下降；第三方未来行为的影响，包括客户关系的重大变化，或医疗产品与服务购买者消费行为、医疗消费模式变化，例如推迟医疗程序、限用处方药、减少就诊频率或放弃医疗保险；Organon或其第三方合作伙伴及其供应商未能履行监管或质量义务；大宗商品价格、燃料、运输费用的波动影响产品供应成本或供货能力。公司不承担因新信息、未来事件或其他原因而更新前瞻性声明的义务。更多可能导致实际结果与前瞻性声明存在重大差异的因素，可见公司向美国SEC提交的文件，包括最新的Form 10-K年度报告（及其修订版）、Form 10-Q 季度报告（及其修订版）、Form 8-K当前报告及其他SEC文件，相关资料可在SEC官网（www.sec.gov）查询。

PERJETA为基因泰克公司（Genentech, Inc.）在美国注册的商标；Organon与该商标持有人不存在任何关联。

Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US

SHANGHAI, China & JERSEY CITY, NJ – November 17, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.1 POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers.2

"Expanding access to treatments for diseases that disproportionately impact women, including breast cancer, the most common cancer among women in the US excluding skin cancer, is at the core of our mission,” said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.3 “Not only is POHERDY the first approved biosimilar to PERJETA in the US, but its approval also builds on Organon’s recent momentum of expanding our biosimilars portfolio in women's health and oncology. Our collaboration with Henlius is critical to our goal of making health care more sustainable for US patients.”

“The FDA approval of POHERDY marks a significant milestone in Henlius’ global expansion and quality biologics development. As the first pertuzumab biosimilar approved in the US, this important achievement demonstrates our core capability to build a sustainable global R&D system grounded in rigorous scientific and regulatory standards. It also reflects Henlius’ steadfast commitment to its patient-centric philosophy and long-term global strategy,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “We will continue accelerating the delivery of quality biologics to benefit more patients worldwide and create greater value for human health.”2

“The approval of POHERDY further underscores Henlius’ track record in international registration, together with our strength in quality management and commercialization collaboration,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “We look forward to working closely with our partner Organon to leverage our complementary strengths in supply chain, market, and distribution networks, jointly enhancing access to quality biologics and providing patients with treatment options that combine quality and affordability.”2

POHERDY is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic 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 (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence. See full indications below.

Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function. Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. See additional safety information below.

POHERDY was approved based on the review of a comprehensive data package, which includes analytical similarity, clinical pharmacokinetic studies, and comparative clinical studies demonstrating that POHERDY is highly similar to and interchangeable with the reference product PERJETA in terms of safety, purity, and potency (safety and effectiveness).4,5

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to multiple biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6 The FDA approval of POHERDY will further enhance the partners’ oncology portfolio and their ability to deliver quality biologics to more patients.2

About POHERDY® (pertuzumab-dpzb)

POHERDY is a HER2/neu receptor antagonist indicated for:

  • Metastatic Breast Cancer (MBC): POHERDY is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

  • Early Breast Cancer (EBC): POHERDY is indicated for use in combination with trastuzumab and chemotherapy for:

    ◽The neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer

    ◽The adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence

SELECTED SAFETY INFORMATION

LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY

  • Pertuzumab products can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue POHERDY treatment for a confirmed clinically significant decrease in left ventricular function.

  • Exposure to pertuzumab products can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception.

CONTRAINDICATIONS

POHERDY is contraindicated in patients with known hypersensitivity to pertuzumab products or to any of its excipients.

WARNINGS AND PRECAUTIONS

Left Ventricular Dysfunction Pertuzumab products can cause left ventricular dysfunction, including symptomatic heart failure. Decreases in LVEF have been reported with drugs that block HER2 activity, including pertuzumab products.

Assess LVEF prior to initiation of POHERDY and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of POHERDY and trastuzumab.

In the pertuzumab-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients, and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction.

In patients receiving pertuzumab as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to <50% occurred in 8% of patients, and left ventricular dysfunction occurred in 3% of patients. LVEF recovered to ≥50% in all of these patients.

In patients receiving neoadjuvant pertuzumab in TRYPHAENA, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with pertuzumab plus trastuzumab and fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by pertuzumab plus trastuzumab and docetaxel, 16% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 11% of patients treated with pertuzumab in combination with docetaxel, carboplatin, and trastuzumab (TCH). Left ventricular dysfunction occurred in 6% of patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel, 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, and 3% of patients treated with pertuzumab in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC, 1% of patients treated with pertuzumab in combination with TCH, and none of the patients treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel. LVEF recovered to ≥50% in all but 1 patient.

In patients receiving neoadjuvant pertuzumab in BERENICE, in the neoadjuvant period, LVEF decline ≥10% and a drop to <50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and 2% of patients treated with pertuzumab plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and 4% of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (New York Heart Association [NYHA] Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with pertuzumab plus trastuzumab and paclitaxel following ddAC and none of the patients treated with pertuzumab plus trastuzumab and docetaxel following FEC in the neoadjuvant period.

In patients receiving adjuvant pertuzumab in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was 0.6%. Of the patients who experienced symptomatic heart failure, 47% of pertuzumab-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥10% and a drop to <50% were reported in 3% of pertuzumab-treated patients, of whom 80% recovered at the data cutoff.

Pertuzumab products have not been studied in patients with a pretreatment LVEF value of <50%; a prior history of CHF; decreases in LVEF to <50% during prior trastuzumab therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment, or a cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equivalent.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings in animal studies, pertuzumab products can cause fetal harm when administered to a pregnant woman. Pertuzumab products are HER2/neu receptor antagonists. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy.

Verify the pregnancy status of females of reproductive potential prior to the initiation of POHERDY. Advise pregnant women and females of reproductive potential that exposure to POHERDY in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of POHERDY in combination with trastuzumab.

Infusion-Related Reactions

Pertuzumab products can cause serious infusion reactions, including fatal events.

In CLEOPATRA, on the first day, when only pertuzumab was administered, infusion-related reactions occurred in 13% of patients, and <1% were Grade 3 or 4. The most common infusion reactions (≥1%) were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity, and vomiting. During the second cycle when all drugs were administered on the same day, the most common infusion reactions in the pertuzumab-treated group (≥1%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting.

In APHINITY, when pertuzumab was administered in combination with trastuzumab and chemotherapy on the same day, infusion-related reactions occurred in 21% of patients, with <1% of patients experiencing Grade 3-4 events.

Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of POHERDY. If a significant infusion-related reaction occurs, slow or interrupt the infusion, and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions.

Hypersensitivity Reactions/Anaphylaxis

Pertuzumab products can cause hypersensitivity reactions, including anaphylaxis.

In CLEOPATRA, the overall frequency of hypersensitivity/anaphylaxis reactions was 11% in pertuzumab-treated patients, with Grade 3-4 hypersensitivity reactions and anaphylaxis occurring in 2% of patients.

In NeoSphere, TRYPHAENA, BERENICE, and APHINITY, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the pertuzumab-treated group. The incidence was highest in the pertuzumab plus TCH–treated group (8%), with 1% Grade 3-4 events.

Observe patients closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis and fatal events, has been observed in patients treated with pertuzumab products. Angioedema has been described in postmarketing reports. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use prior to administration of POHERDY.  

ADVERSE REACTIONS

Metastatic Breast Cancer The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Neoadjuvant Treatment of Breast Cancer The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.

The most common adverse reactions (>30%) with pertuzumab in combination with TCH were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.

The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.

Adjuvant Treatment of Breast Cancer The most common adverse reactions (>30%) with pertuzumab in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

Before prescribing POHERDY, please read the Prescribing Information, including the Boxed Warning about left ventricular dysfunction and embryo-fetal toxicity.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 10 products have been approved for marketing across multiple countries and regions, and 3 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos® and Bilprevda®, and pertuzumab Poherdy®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

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

Except for historical information, 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 expanding access to treatments for patients with HER2-positive breast cancer, the potential market opportunity for POHERDY, the expansion of Organon’s biosimilars portfolio, Organon’s collaboration with Henlius, and Henlius’ global expansion and biologics development. Forward-looking statements may be identified by words such as “goal,” “continue,” “forward,” “vision,” “mission,” “expect,” “explore,”  “future,” “believes,” “will,” “potential,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’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. Risks and uncertainties include, but are not limited to, an inability to market HLX11, an investigational biosimilar of PERJETA (pertuzumab), in Europe; expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the US or other governments; changes in US and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; an inability to fully execute on Organon’s product development and commercialization plans; manufacturing difficulties or delays; disruptions at the US Food and Drug Administration, the US Securities and Exchange Commission (the “SEC”) and other US and comparable foreign government agencies; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).

PERJETA is a trademark registered in the US by Genentech, Inc.; Organon is not associated with this trademark owner.