摘要：中国上海和美国新泽西，2025年3月28日，复星医药子公司复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，Perjeta®（帕妥珠单抗）生物类似药HLX11的上市许可申请（MAA）获欧洲药品管理局（EMA）受理。

转自：复星医药

中国上海和美国新泽西，2025年3月28日，复星医药子公司复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，Perjeta®（帕妥珠单抗）生物类似药HLX11的上市许可申请（MAA）获欧洲药品管理局（EMA）受理。

目前帕妥珠单抗已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2阳性、局部晚期、炎性或早期乳腺癌患者，以及部分HER2阳性早期乳腺癌患者的辅助治疗等。

此次递交主要基于一项多中心、随机、双盲、平行对照的III期临床试验（NCT05346224），旨在比较HLX11与原研帕妥珠单抗用于HER2阳性、HR阴性的早期或局部晚期乳腺癌患者新辅助治疗的疗效和安全性。研究达到由独立评审委员会（IRC）评估的总体病理完全缓解（tpCR）率这一主要终点，次要终点指标在两组间亦呈现可比性。

复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX11在内的两款产品在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。

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，已有6款产品在中国获批上市，4款产品在国际获批上市，5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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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是一家专注于守护女性全生命周期健康的全球化独立医疗健康公司。Organon提供超过70种女性健康相关药物和医疗解决方案的产品组合，另有持续增长的生物类似药业务和覆盖一系列疾病治疗领域的大量经典品牌业务。依靠现有业务，Organon能够以强健的现金流优势，持续投资女性健康和生物类似药领域的创新和未来增长机会。此外，Organon也在积极探求与生物制药创新企业开展合作，发挥公司在快速增长的国际市场中的规模与资源优势，帮助它们实现产品的商业化。

Organon在全球已实现大规模、广覆盖的发展，并具备世界一流的商业运营能力，总部设在美国新泽西州泽西市，全球约有10,000名员工。

- 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HLX11上市许可申请及市场前景预期的相关表述。前瞻性陈述可通过“探索”、“机会、“有望”、“寻求”、“未来”或具有类似含义的措辞识别。这些前瞻性陈述基于Organon管理层当前的计划和预期，并受到重大风险和不确定性的影响，如基本假定不准确或风险或不确定性成为现实，实际结果可能与前瞻性声明中所述的结果有重大差异。风险和不确定性包括但不限于：作为Perjeta®（帕妥珠单抗）在研生物类似药的HLX11可能无法在欧洲完成市场准入令Organon业务发展战略面临实施障碍；经济状况恶化可能对HLX11需求水平造成不利影响；全球定价压力加剧，包括医保管理机构规则与实务、司法裁决、涉及Medicare/Medicaid的医疗改革法案、药品报销与定价的政府法规；Organon药品开发及商业化计划可能无法充分落实；政府行为可能对市场营销活动产生不利影响；生产环节的障碍或延迟；生产延迟、供应商违约导致的原料断供、包装及运营成本上升等供应链问题；与商业合作伙伴关系维护困难；产品专利到期后面临仿制药竞争；美国食品药品监督管理局（FDA）、美国证券交易委员会（SEC）及其他可比境外监管机构运作中断，以及Organon或其第三方合作方/供应商未履行法规或质量义务等情形。

Organon不承担因新信息、未来事件或其他因素公开更新任何前瞻性声明的义务。Organon在提交给美国证券交易委员会（SEC）的资料中列出了可能导致实际结果与前瞻性声明中描述内容产生显著偏差的其它因素，包括在表格10-K中提交的Organon最新年报和之后提交给SEC的文件。详情可在SEC网站（www.sec.gov）查阅。提供网站参考和链接仅供参考，任何此类网站上的信息均不构成本新闻稿的一部分，也不通过引用并入本新闻稿。Organon不对第三方网站内容负责。

European Medicines Agency (EMA) Validates Henlius and Organon

Filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11

SHANGHAI, China & JERSEY CITY, N.J - March 28, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications.

The submission was based on a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study (NCT05346224) aimed to compare the efficacy and safety of HLX11 with reference Perjeta® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early-stage, or locally advanced breast cancer as part of a complete treatment regimen. HLX11 met the primary endpoint, which was the total pathological complete response (tpCR) rate assessed by an Independent Review Committee (IRC). Other secondary endpoint indicators are also comparable between the two groups.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.

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. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

About Organon

Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon’s scale and agile presence in fast growing international markets.

Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

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 U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding marketing authorization applications and prospects for HLX11. Forward-looking statements may be identified by words such as “explore,” “opportunity,” “expect,” “pursuing,” “future,” or 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. Risks and uncertainties include, but are not limited to, an inability to market HLX11, an investigational biosimilar of Perjeta® (pertuzumab), in Europe, an inability to execute on Organon’s business development strategy; weakening of economic conditions that could adversely affect the level of demand for HLX11; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans; governmental initiatives that adversely impact Organon’s marketing activities; manufacturing difficulties or delays; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; disruptions at the U.S. Food and Drug Administration, the U.S. Securities and Exchange Commission (the “SEC”) and other U.S. and comparable foreign government agencies; and the failure by Organon or its third party collaborators and/or their suppliers to fulfill its or their regulatory or quality obligations. Organon 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 Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

来源：新浪财经