复星医药子公司复宏汉霖再获欧盟GMP认证，两款生物类似药欧盟登陆再提速！

2025年7月2日，复星医药子公司复宏汉霖（2696.HK）宣布，公司正式获得比利时联邦药品和保健产品管理局（Federal Agency for Medicines and Health Products）就其在研Prolia/Xgeva（地舒单抗）生物类似药HLX14和Perjeta（帕妥珠单抗）生物类似药HLX11的相关产线签发的GMP证书（Certificate of GMP Compliance of a Manufacturer），根据欧盟成员国之间的GMP互认制度，这标志着HLX14和HLX11相关生产线已符合欧盟GMP标准。这也是继曲妥珠单抗汉曲优和PD-1抑制剂H药 汉斯状（斯鲁利单抗）后，复宏汉霖生产质量体系再获欧盟GMP认证。

HLX14和HLX11为复宏汉霖按照中国、欧盟和美国等生物类似药相关法规自主研制的生物类似药。2022年6月，复宏汉霖与Organon LLC达成授权许可和供应合作，授予其对HLX14和HLX11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。复宏汉霖分别针对HLX14和HLX11开展一系列头对头对比原研药物的研究，此前已就HLX14获得欧盟、美国、加拿大上市许可申请受理，拟用于骨折高风险的绝经后妇女的骨质疏松症等适应症，并就HLX11获得中国、欧盟、美国、加拿大上市许可申请受理，拟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的新辅助治疗，或作为早期乳腺癌完整治疗方案的一部分，以及用于具有高复发风险的HER2 阳性早期乳腺癌患者的辅助治疗等其他原研获批适应症。

自成立之初，复宏汉霖始终对标国际最高标准，建立起符合各国药监要求的质量管理体系，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。公司商业化生产基地及配套的质量管理体系已通过近100项由中国、欧盟、美国及多个PIC/S成员国（印尼、巴西）等药监机构和国际商业合作伙伴实施的多项实地核查及审计，实现中国、东南亚、北美、欧洲、中东及拉丁美洲等地区商业化供货。未来，复宏汉霖将继续以全球领先的质量体系为基石，扩大高质量生物药的可及范围，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。

Henlius Receives New EMA GMP Certification, Accelerating European Market Entry of Two Biosimilar Candidates

Shanghai, China, July 2, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the GMP Certificate, issued by the Federal Agency for Medicines and Health Products in Belgium, for the production lines of HLX14, an investigational biosimilar candidate of Prolia and Xgeva (denosumab), and HLX11, an investigational biosimilar candidate of Perjeta (pertuzumab). According to the GMP mutual recognition system among European Union (EU) member states, it marks that the related production lines have met the EU GMP standards. The inspection success, as well as the previous certification by the EMA GMP for Henlius’ self-developed trastuzumab biosimilar HANQUYOU and innovative PD-1 inhibitor serplulimab HANSIZHUANG, reconfirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards.

HLX14 and HLX11 are biosimilar candidates independently developed by Henlius in accordance with regulatory guidelines for biosimilars in China, the EU and the United States (US). In 2022, Henlius entered into a license and supply agreement with Organon LLC, granting Organon LLC the exclusive commercialization rights to the two biosimilar candidates. The agreement covers markets such as the US, the EU, and Canada. An exception to the agreement is China. Henlius has conducted a series of head-to-head studies comparing HLX14 and HLX11 with their respective reference biologics. Previously, the marketing applications for HLX14 have been accepted in the EU, the US, and Canada. HLX14 is indicated for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The marketing applications for HLX11 have been accepted in China, the EU, the US, and Canada. HLX11 is indicated for combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer as part of a complete treatment regimen for early-stage breast cancer, and adjuvant treatment of patients with HER2-positive early-stage breast cancer at high risk of recurrence, among other approved indications of the reference product.

Since its inception, Henlius has aligned itself with the highest international standards and established a quality management system that complies with regulatory requirements across multiple countries. The system covers the entire product continuum ranging from research and development to material management, product manufacturing, quality control, product supply management and product post-marketing surveillance. The manufacturing sites and the supporting quality management system have passed nearly 100 on-site inspections and audits conducted by international business partners and regulatory authorities，including the NMPA, the EMA, the US FDA, and PIC/S members such as Indonesia and Brazil. Henlius has built stable manufacturing and supply capabilities to support markets in China, Southeast Asia, North America, Europe, the Middle East, and Latin America.

Looking ahead, Henlius will continue building on its world-class quality system to expand access to high-quality biologics and benefit a broader population of 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, 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.

(复星医药)