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.