汉霖头条 | 复宏汉霖曲妥珠单抗获美国FDA批准上市

• 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；

• 汉曲优现已在全球40余个国家和地区获批上市，惠及逾18万患者；

• 复宏汉霖加快全球布局，令高品质生物药惠及全球患者

2024年4月26日，复宏汉霖（2696.HK）宣布，公司商务合作伙伴Accord BioPharma Inc.（Intas美国子公司，“Accord”）于近日收到美国食品药品监督管理局（FDA）通知，由复宏汉霖自主研发、生产的曲妥珠单抗生物类似药HERCESSI（HLX02，中国商品名：汉曲优，欧洲商品名：Zercepac）获美国批准上市，用于辅助治疗人表皮生长因子受体-2（HER2）过表达的乳腺癌、HER2过表达的转移性乳腺癌，以及HER2过表达的转移性胃腺癌或胃食管交界腺癌。汉曲优是在中国、欧盟、美国获批的“中国籍”单抗生物类似药，此前已于2020年7月及8月先后获得欧盟委员会与中国国家药监局（NMPA）批准上市。

复宏汉霖执行董事、首席执行官兼首席财务官

朱俊先生

汉曲优是复宏汉霖严格按照中国、欧盟和美国等生物类似药法规自主研发的曲妥珠单抗，也是公司首个通过FDA批准在美国开展商业化的产品。以患者为中心的初心驱使我们不断探索优质高效、更可负担和可及的治疗选择，而坚定推动汉曲优在全球40余个市场获批上市，正是复宏汉霖对患者关切的真实回应。我们期待将更多的北美患者纳入我们惠及的范围，让他们能够以更具性价比的方式获得高品质的生物药。

Intas副董事长兼董事总经理

Binish Chudgar先生

Intas首款FDA批准生物类似药是公司美国分部的一项重要业务成就，而这仅仅是一个起点。我们希望可以构建最为全面的生物类似药组合，为满足患者和医疗服务提供方的需求，并助力美国医疗系统实现大幅节约。我们的愿景和初心始终围绕让医疗更加可负担，而这项获批无疑将助推我们实现这一愿景，为治疗过程中涉及的各个关键利益相关方提供更多价值，确保他们能够获得所需的药物。

Accord美国总裁

Chrys Kokino先生

我们在美国市场获得批准的首款生物类似药HERCESSI，代表了Accord在提升患者用药机遇上迈出的关键一步。乳腺癌和胃癌是最常见的癌症类型之一，而癌症治疗常常伴随着沉重的经济负担，因此有必要为患者提供更多经济实惠的治疗选择，例如生物类似药。

秉心而行，以国际品质惠及更多患者

乳腺癌是全球第二高发肿瘤^[1]。据美国癌症协会数据显示，2024年美国乳腺癌新发病例预计将超过37万例，位居该国癌症发病率第一，并呈现逐年增长的态势^[2]。其中，HER2过表达的乳腺癌约占乳腺癌总数的15%-20%^[2]。另一方面，胃癌患者的HER2过表达比率约为12%-23%^[3]。曲妥珠单抗正是治疗HER2阳性乳腺癌和胃癌的基石类药物。自2020年7月及8月先后于欧盟和中国获批上市以来，汉曲优（美国商品名：HERCESSI, 欧洲商品名：Zercepac）目前已成功于英国、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（美国商品名：HERCESSI, 欧洲商品名：Zercepac）已惠及逾18万名患者。

此次FDA批准主要基于复宏汉霖递交的全面的分析结果、临床前及临床研究数据。自2015年以来，复宏汉霖针对汉曲优（美国商品名：HERCESSI, 欧洲商品名：Zercepac）开展了一系列的头对头比对研究，包括质量对比研究、临床I期和国际多中心临床III期研究等。这些数据充分证明了汉曲优（美国商品名：HERCESSI, 欧洲商品名：Zercepac）与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。

矢志不渝，以最高标准践行汉霖品质

汉曲优（美国商品名：HERCESSI, 欧洲商品名：Zercepac）多次获得国际权威药监机构的认可，也得益于复宏汉霖长期对产品质量的严格要求。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）。这是继中国和欧盟药品生产质量管理规范（GMP）认证后复宏汉霖再获国际认可，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。

复宏汉霖现已建立一套符合国际质量标准的质量管理体系，覆盖从项目研发到物料管理、产品生产、质量控制、产品供应链管理以及产品上市后跟踪的全生命周期。公司建有徐汇基地、松江基地（一）及松江基地（二）三个生产基地，现有商业化总产能已达48,000升，实现全球产品常态化供应，全面覆盖中国、东南亚、欧洲及拉丁美洲。此前，公司商业化生产基地及配套的质量管理体系已通过中国国家药监局、欧洲药品管理局（EMA）、美国食药监局（FDA）、欧盟质量受权人（QP）以及公司国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟和美国GMP认证。

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和Elea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。随着汉曲优不断拓展到更广阔市场，复宏汉霖将加速为全球患者提供可负担的高品质生物药。

【参考文献】

[1] Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: .who.int/today, accessed [29 January 2024]

[2] American Cancer Society. Cancer Facts and Figures 2024. Atlanta: American Cancer

Society; 2024.

[3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer V.3.2023

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，在国际上市2款产品，19项适应症获批，6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 Receives FDA Approval in the United States

• HLX02 (trastuzumab-strf, trade name: HANQUYOU in China, HERCESSI in the U.S. and Zercepac in Europe) is a China-developed mAb biosimilar approved in China, Europe, and U.S.

• HLX02 was approved in more than 40 countries and regions around the world, benefiting more than 180,000 patients

• Henlius accelerates global expansion, delivering high-quality biologics to patients worldwide

Shanghai, China, April 26, 2024 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty division of Intas Pharmaceuticals, Ltd.), has received approval from the United States Food and Drug Administration (FDA) for HERCESSI (HLX02, trastuzumab-strf, biosimilar to Herceptin trade name: HANQUYOU in China and Zercepac in Europe), a trastuzumab biosimilar self-developed and -manufactured by Henlius. The product has been approved in the United States (U.S.) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HLX02 is a China-developed monoclonal antibody (mAb) biosimilar approved in China, the European Union (EU) and U.S., with previous approvals for commercialisation by the European Commission (EC) and National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively.

Mr. Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius remarked, “Henlius independently developed HLX02 in accordance with the NMPA, the European Medicines Agency (EMA), the FDA and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius' response to patients' concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics.”

“Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we’re just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings,” said Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals. “Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”  

“The approval of HERCESSI - our first biosimilar to be approved in the U.S. - marks an important milestone for Accord BioPharma in our efforts to improve access for patients," said Chrys Kokino, U.S. president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”

HLX02 to benefit global patients

Breast cancer is the second most diagnosed cancer ^[1]. According to the American Cancer Society, over 370,000 new cases of breast cancer will be diagnosed in the U.S. in 2024, ranking first in the country's cancer incidence rates and showing year-over-year growth ^[2]. About 15% to 20% of breast tumors are HER2-positive breast cancers ^[2]. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23% ^[3]. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers. Since its approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, HERCESSI in the U.S., Zercepac in Europe) has been successfully approved in more than 40 countries and regions, including the United Kingdom, 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 United Kingdom (UK), France and Germany. To date, HLX02 has benefited more than 180,000 patients.

HLX02 (trade name: HANQUYOU in China, HERCESSI in the U.S., Zercepac in Europe) was granted approval by the FDA based on a comprehensive package of analytical, pre-clinical and clinical study data submitted by Henlius. Since 2015, Henlius has conducted a series of head-to-head studies for HLX02, including comparative quality analytical studies, a phase 1 PK similarity study and a global multicentre phase 3 clinical study. The data indicates that HLX02 is highly similar to reference trastuzumab in terms of quality, safety, and efficacy.

Henlius Quality in line with highest quality standards

HLX02 (trade name: trade name: HANQUYOU in China, HERCESSI in the U.S., Zercepac in Europe) has received recognition from global regulatory authorities for its longstanding commitment to maintaining manufacturing systems that comply with the highest quality standards. In 2023, the manufacturing site and facility where HLX02 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, make Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs.

Henlius has established a quality management system in accordance with the highest quality standards. The system covers the entire product life cycle from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. The company has built 3 manufacturing facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current total commercial production capacity has reached 48,000 liters and maintains stable supply in China, Southeast Asia, Europe, and Latin America. The company's commercial production facilities and supporting quality management system have passed on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person, as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies.

Henlius has aggressively pursued international commercialization of HLX02 and is actively collaborating with global partners such as Accord, Abbott, Eurofarma, and Elea to bring its therapeutics to patients in the U.S., Canada, Europe, and other emerging markets, covering about 100 countries and regions. As the product expands into more countries, Henlius will accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.

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, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 6 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 for injection, 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.    

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