首发中东，目标沙特！中美欧获批生物类似药汉曲优®实现中东商业化_新闻动态_新闻及媒体资源

首发中东，目标沙特！中美欧获批生物类似药汉曲优^®实现中东商业化

发布时间:2024-06-06 内容来源于：浏览量：

内容来源：复宏汉霖

汉曲优^®有望成为首个登陆中东市场的国产单抗生物药，再拓海外销售版图

汉曲优^®已成功于全球40多个国家和地区获批上市

复宏汉霖首次发货中东地区，实现中国、欧洲、东南亚、拉美、中东商业化供货

2024年6月6日，复宏汉霖自主研发和生产的汉曲优^®（美国商品名：HERCESSI™，欧洲商品名：Zercepac^®）正式从公司徐汇基地发出，前往沙特阿拉伯，有望成为首个登陆中东市场的国产单抗生物药。这标志着公司首次商业化发货至中东北非区域，这一里程碑的达成得益于公司与国际合作伙伴Intas及其子公司Accord达成的独家商业化合作，广泛覆盖欧洲、北美、部分中东及北非地区、部分独联体国家市场。

汉曲优^{^®}（美国商品名：HERCESSI™，欧洲商品名：Zercepac^{^®}）是在中国、欧盟、美国获批的“中国籍”单抗生物类似药，现已成功于美国、英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、泰国等超过40个国家和地区获批上市，覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，并进入中国、英国、法国和德国等多个国家的医保目录。截至目前，汉曲优^{^®}已惠及逾19万名患者。

复宏汉霖执行董事、首席执行官兼首席财务官

朱俊先生

此次汉曲优^®启航前往沙特，加速拓展至中东及北非市场，乃至全球市场，不仅仅是复宏汉霖国际化战略的体现，也是我们践行向全球患者提供可负担的高品质生物药的坚定承诺。我们期待与国际合作伙伴共同努力，让生命的希望之光传递到每一个需要的角落。

汉曲优^{^®}（美国商品名：HERCESSI™, 欧洲商品名：Zercepac^{^®}）的研发、生产和质量控制环节遵循国际最高标准。此次汉曲优^{^®}的发货基地徐汇基地是国内首个获得中欧双GMP认证用于生产自主研发抗体生物药的生产基地。该生产基地及配套的质量管理体系已通过近百项由NMPA、欧洲药品管理局（EMA）、PIC/S成员印尼食品药品监督管理局（BPOM）和巴西国家卫生监督管理局（ANVISA）、欧盟质量受权人（QP）及公司国际商业合作伙伴进行的多项实地核查及审计。2023年，汉曲优^{^®}（美国商品名：HERCESSI™, 欧洲商品名：Zercepac^{^®}）相关生产场地和设施接受并顺利通过美国FDA的批准前检查（Pre-license Inspection, PLI），复宏汉霖成为通过中国、欧盟、美国GMP认证的自主研发和生产抗体药物的生物制药企业。

围绕汉曲优^{^®}，复宏汉霖前瞻性地开展了国际商业化布局，积极开拓海外市场，携手全球商业合作伙伴Accord、Abbott、Eurofarma、Elea和KGbio等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球约100个国家和地区。公司将继续与国际合作伙伴共同推进汉曲优^{^®}以及其他产品在国际市场的全球上市进程，惠及更广泛的患者群体。

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，已在中国上市5款产品，在国际获批上市3款产品，23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。继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）和汉贝泰^{^®}（贝伐珠单抗）相继获批上市，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。

Henlius Trastuzumab Begins its Journey to Saudi Arabia

HANQUYOU is poised to be the first Chinese monoclonal antibody to enter the Middle Eastern market, further expanding its global presence -
HANQUYOU was approved in more than 40 countries and regions around the world -
With the first shipment to the Middle East, Henlius has realized commercialized supply across China, Europe, Southeast Asia, Latin America, and now the Middle East -

On June 6, 2024, Henlius' independently developed and produced product, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac^{^®} in Europe), left Henlius’ Xuhui Facility, heading to Saudi Arabia, with the expectation of being the first Chinese monoclonal antibody (mAb) biosimilar to hit the market in the Middle East. This milestone signifies the company’s first commercialized delivery to the Middle East and North African (MENA) countries and is a testament to the exclusive commercial partnership formed with the international partner Intas and its subsidiary Accord, covering parts of Europe, North America, certain areas of MENA, and CIS countries.

Mr. Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius stated, “The launch of HANQUYOU to Saudi Arabia, accelerating its expansion to the markets of the MENA, and beyond to the global market, is not only a reflection of Henlius’ globalization strategy but also a solid demonstration of our commitment to providing patients worldwide with quality and affordable biologics. We look forward to working with our global business partners to bring the beacon of hope to every corner of the world that needs it.”

HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac^{^®} in Europe) is a China-developed mAb biosimilar approved in China, the European Union (EU) and U.S. It is now approved in more than 40 countries and regions including the U.S., United Kingdom (UK), France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. To date, HANQUYOU has benefited over 190,000 patients.

The development, manufacturing and the quality management system of HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac^{^®} in Europe) are in line with global standards. The Xuhui Facility, from which HANQUYOU has been shipped, is the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners. In 2023, the manufacturing site and facility where HANQUYOU is manufactured underwent and successfully passed the Pre-License Inspection (PLI) by the FDA. The success of the FDA PLI, as well as the previous GMP certifications from China and EU regulatory agencies, makes Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs.

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, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 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 pro-actively 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) and HANBEITAI (bevacizumab), 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.