产品速递 | 帕妥珠单抗生物类似药HLX11临床III期对照研究达到主要研究终点

中国上海和美国新泽西，2024年9月30日，复宏汉霖（2696.HK）与Organon（NYSE: OGN）共同宣布，在研帕妥珠单抗（PERJETA^®）生物类似药HLX11的临床III期对照研究达到了主要研究终点。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。

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，3款产品在国际获批上市，24项适应症获批，3个上市申请分别获中国药监局和欧盟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50多个分子，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）以及汉奈佳^®（奈拉替尼），此外，创新产品汉斯状^®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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医疗健康公司。Organon提供超过60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 -

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”，包括但不限于基于Organon与复宏汉霖商业计划的预期表述。前瞻性陈述可通过“寻求”、“机会”、“愿景”、 “将”或具有类似含义的措辞识别。这些前瞻性陈述基于Organon管理层当前的看法和预期，并受到重大风险和不确定性的影响，如果这些风险和不确定性真实发生，可能导致实际结果可能与前瞻性陈述中所述的结果存在重大差异。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。

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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China 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 proactively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products 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) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.

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

Cautionary Note Regarding Forward-Looking Statements

Some statements and disclosures in this press release are “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 the business plans of Organon and Henlius. Forward-looking statements may be identified by words such as “pursuing,” “opportunities,” “vision,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of 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 Securities and Exchange Commission (“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).