2025年7月2日，復星醫藥子公司復宏漢霖（2696.HK）宣布，公司正式獲得比利時聯邦藥品和保健產品管理局（Federal Agency for Medicines and Health Products）就其在研Prolia/Xgeva（地舒單抗）生物類似藥HLX14和Perjeta（帕妥珠單抗）生物類似藥HLX11的相關產線簽發的GMP證書（Certificate of GMP Compliance of a Manufacturer），根據歐盟成員國之間的GMP互認制度，這標志著HLX14和HLX11相關生產線已符合歐盟GMP標準。這也是繼曲妥珠單抗漢曲優和PD-1抑制劑H藥 漢斯狀（斯魯利單抗）后，復宏漢霖生產質量體系再獲歐盟GMP認證。

HLX14和HLX11為復宏漢霖按照中國、歐盟和美國等生物類似藥相關法規自主研制的生物類似藥。2022年6月，復宏漢霖與Organon LLC達成授權許可和供應合作，授予其對HLX14和HLX11在除中國以外的全球區域進行獨家商業化的權益，協議覆蓋美國、歐盟、加拿大等市場。復宏漢霖分別針對HLX14和HLX11開展一系列頭對頭對比原研藥物的研究，此前已就HLX14獲得歐盟、美國、加拿大上市許可申請受理，擬用于骨折高風險的絕經后婦女的骨質疏松癥等適應癥，并就HLX11獲得中國、歐盟、美國、加拿大上市許可申請受理，擬聯合曲妥珠單抗和化療用于HER2陽性、局部晚期、炎性或早期乳腺癌患者的新輔助治療，或作為早期乳腺癌完整治療方案的一部分，以及用于具有高復發風險的HER2 陽性早期乳腺癌患者的輔助治療等其他原研獲批適應癥。

自成立之初，復宏漢霖始終對標國際最高標準，建立起符合各國藥監要求的質量管理體系，覆蓋從項目研發到物料管理、產品生產、質量控制、產品供應鏈管理以及產品上市后跟蹤的全生命周期。公司商業化生產基地及配套的質量管理體系已通過近100項由中國、歐盟、美國及多個PIC/S成員國（印尼、巴西）等藥監機構和國際商業合作伙伴實施的多項實地核查及審計，實現中國、東南亞、北美、歐洲、中東及拉丁美洲等地區商業化供貨。未來，復宏漢霖將繼續以全球領先的質量體系為基石，擴大高質量生物藥的可及范圍，惠及更廣泛的患者群體。

關于復宏漢霖

復宏漢霖（2696.HK）是一家國際化的創新生物制藥公司，致力于為全球患者提供可負擔的高品質生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域，已有6款產品在中國獲批上市，4款產品在國際獲批上市，5個上市申請分別獲中國藥監局、美國FDA和歐盟EMA受理。自2010年成立以來，復宏漢霖已建成一體化生物制藥平臺，高效及創新的自主核心能力貫穿研發、生產及商業運營全產業鏈。公司已建立完善高效的全球創新中心，按照國際藥品生產質量管理規范（GMP）標準進行生產和質量管控，不斷夯實一體化綜合生產平臺，其中，公司商業化生產基地已相繼獲得中國、歐盟和美國GMP認證。

復宏漢霖前瞻性布局了一個多元化、高質量的產品管線，涵蓋約50個分子，并全面推進基于自有抗PD-1單抗H藥漢斯狀的腫瘤免疫聯合療法。截至目前，公司已獲批上市產品包括國內首個生物類似藥漢利康（利妥昔單抗）、自主研發的中美歐三地獲批單抗生物類似藥漢曲優（曲妥珠單抗，美國商品名：HERCESSI，歐洲商品名：Zercepac）、漢達遠（阿達木單抗）、漢貝泰（貝伐珠單抗）、全球首個獲批一線治療小細胞肺癌的抗PD-1單抗漢斯狀（斯魯利單抗，歐洲商品名：Hetronifly）以及漢奈佳（奈拉替尼）。公司亦同步就19個產品在全球范圍內開展30多項臨床試驗，對外授權全面覆蓋歐美主流生物藥市場和眾多新興市場。

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.

(復星醫藥)