VISEN Pharmaceuticals and WuXi Biologics Partner to Manufacture Lonapegsomatropin at WuXi Biologics Chengdu Microbial Site

(June 9th, 2025, Chengdu) - VISEN Pharmaceuticals (VISEN, 2561.HK), an innovative biopharmaceutical company focused on endocrine diseases, and WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that they will launch the technology transfer for the commercial production of VISEN’s core product, lonapegsomatropin at WuXi Biologics’ new microbial manufacturing site in Chengdu. The two companies will also collaborate to establish China’s first dual-chamber lyophilized production line at this site, an innovative formulation technology designed to significantly enhance drug stability and clinical administration convenience. Building on their initial strategic agreement in December 2023 for lonapegsomatropin’s technology transfer, the launch announcement marks a pivotal milestone in advancing localized production and demonstrates substantial progress toward the next phase of collaboration between the two companies. Lonapegsomatropin is long-acting growth hormone (once-weekly) for the treatment of pediatric growth hormone deficiency (PGHD), offering a new therapeutic option for children with PGHD. Already approved in the US and Europe, it is expected to receive the Chinese regulatory approval in 2025. The local production in China is expected in 2028. Technology transfer for local manufacture and the construction of production line for lonapegsomatropin will be carried forward simultaneously at WuXi Biologics’ Chengdu microbial manufacturing site. The site, spanning 95,000 square meters, will focus on drug substance (DS) and drug product (DP) manufacturing, covering commercial production of peptides, antibody fragments, plasmid DNA, enzymes, cytokines, virus-like particles (VLPs), etc. slated for GMP release by the end of 2026. It will be equipped with a 15,000L fermenter with annual DS production capacity of 80 - 110 batches, and will be able to expand to 60,000L in the long run. Notably, China’s first dual-chamber lyophilized production line will be established at the Chengdu site. With the additional vial filling line, the site will be equipped with the combined annual DP production capacity of over 10 million units. VISEN, leveraging its dual-chamber DP patents and WuXi Biologics’ highly efficient manufacturing capability and capacity, will be able to ensure a steady commercial supply of lonapegsomatropin. This reflects VISEN’s strong local production commitment. Through technology sharing, the two companies aim to enhance production efficiency and quality, driving innovation in the pharmaceutical industry. Dr. Chris Chen, CEO of WuXi Biologics , commented: “The inaugural commercial project of lonapegsomatropin at our Chengdu microbial manufacturing site underscores clients’ trust in our microbial technology platform and commercial manufacturing capabilities. By leveraging our globally recognized process development expertise and cGMP-compliant quality systems, we will deliver a fully integrated solution for VISEN Pharmaceuticals from technology transfer to scaled manufacturing. We are committed to not only strengthening this partnership but also expanding our collaborative horizon to bring more innovative therapies to patients across China.” Pony Lu, CEO and Executive Director of VISEN Pharmaceuticals , stated: “Local manufacture is an essential step to VISEN Pharmaceuticals’ strategy. Our strategic partnership with WuXi Biologics reflects its premier technology and capability, rigorous quality management system, and proven commercial manufacturing track records. With its once - weekly dosing, superior safety profile, and efficacy, lonapegsomatropin represents a transformative treatment for PGHD patients. Through our collaboration with WuXi Biologics, we will harness the synergies between their innovation and manufacturing capabilities and our strategic focus, aiming to translate cutting-edge medical breakthroughs into tangible patient benefits.” Approval No.:COMU2025065/EN/SM About WuXi Biologics WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects). WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain. For more information about WuXi Biologics, please visit: www.wuxibiologics.com About VISEN Pharmaceuticals (2561.HK) VISEN is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' need first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market - have set up HQs in Suzhou and established offices in Shanghai, Beijing, Hong Kong and Taipei. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. On March 21st, 2025, VISEN officially listed on HKEX main board. For more information, please visit our website: http://www.visenpharma.com/ Contact us [email protected]

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