WuXi Biologics and VISEN Pharmaceuticals Expand Partnership to Localize Production of Lonapegsomatropin in China
WuXi Biologics ,a global leader in Contract Research, Development, and Manufacturing Organization (CRDMO) services, and VISEN Pharmaceuticals (HKEX: 2561), a clinical-stage biopharmaceutical company dedicated to advancing endocrine disease treatments, have announced the formal launch of the technology transfer process for the commercial production of lonapegsomatropin. This milestone marks a significant step forward in their collaboration, originally initiated in December 2023, and signifies the beginning of domestic manufacturing for VISEN’s flagship product in China.
The manufacturing of lonapegsomatropin will take place at WuXi Biologics’ newly commissioned microbial manufacturing facility in Chengdu, Sichuan Province. This facility will also house China’s first-ever dual-chamber lyophilized production line—a novel technological advancement intended to improve the drug’s stability, simplify administration, and enhance overall patient experience. This new chapter in the strategic partnership between WuXi Biologics and VISEN Pharmaceuticals underscores a shared commitment to innovation, localization, and improved patient care.
A Game-Changing Growth Hormone Therapy
Lonapegsomatropin is a long-acting recombinant human growth hormone (rhGH) therapy designed to be administered once weekly. It is currently approved for the treatment of pediatric growth hormone deficiency (PGHD) in the United States and Europe, where it has demonstrated a favorable safety and efficacy profile. As a next-generation therapy, lonapegsomatropin addresses the significant unmet needs of PGHD patients and their caregivers, offering a more convenient alternative to traditional daily growth hormone injections.
VISEN Pharmaceuticals expects to obtain regulatory approval for lonapegsomatropin in China by 2025. Localized commercial production is anticipated to begin by 2028, following the completion of the technology transfer and necessary scale-up processes.
Advancing Local Biomanufacturing Capabilities
The decision to initiate production at WuXi Biologics’ Chengdu site is not only strategic but symbolic. The microbial manufacturing site is one of WuXi Biologics’ newest facilities, equipped with state-of-the-art bioprocessing technology and compliant with global cGMP (current Good Manufacturing Practice) standards. By choosing this facility, VISEN Pharmaceuticals is reinforcing its commitment to ensuring high-quality, locally manufactured biotherapeutics for Chinese patients.
The dual-chamber lyophilized formulation line being developed at the site represents a first-of-its-kind capability in China. This innovative technology is designed to enable reconstitution of lyophilized drugs in a user-friendly, prefilled system, reducing complexity in clinical administration and increasing product stability—a crucial consideration for therapies like lonapegsomatropin that target pediatric populations.
Leadership Perspectives on the Collaboration
Dr. Chris Chen, CEO of WuXi Biologics, emphasized the importance of the new project within the broader context of the company’s capabilities and strategic growth in microbial biologics manufacturing.
“The inaugural commercial project of lonapegsomatropin at our Chengdu microbial manufacturing site underscores clients’ trust in our microbial technology platform and commercial manufacturing capabilities,” Dr. Chen said. “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.”
This integrated model aligns with WuXi Biologics’ goal of offering end-to-end solutions—from early-stage development to commercial production—to its global and domestic partners. The company has rapidly expanded its manufacturing infrastructure in recent years, particularly in China, to support the growing demand for biologics.
Pony Lu, CEO and Executive Director of VISEN Pharmaceuticals, shared similar optimism regarding the expanded partnership.
“Local manufacture is an essential step to VISEN Pharmaceuticals’ strategy,” Lu said. “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.”
Aligning with China’s Biopharmaceutical Development Agenda
This collaboration is also aligned with broader national and industry trends. As China continues to invest heavily in biopharmaceutical innovation and local manufacturing capacity, partnerships such as this one between WuXi Biologics and VISEN Pharmaceuticals demonstrate how global-standard biomanufacturing can be brought to Chinese soil. The project not only supports VISEN’s long-term commercialization goals but also contributes to China’s aspirations to become a global hub for biologics innovation and production.
By investing in localized production of advanced biologics, companies can reduce dependency on imported products, streamline regulatory processes, and enhance supply chain resilience—key factors in ensuring sustainable access to critical therapies for the Chinese population.
Lonapegsomatropin: Positioned for Strong Market Entry in China
Once approved, lonapegsomatropin is expected to capture significant market share in the Chinese pediatric endocrinology space. Growth hormone deficiency affects thousands of children in China, and current treatment options—typically requiring daily injections—pose adherence challenges for both young patients and caregivers. With a once-weekly dosing regimen and improved tolerability, lonapegsomatropin stands out as a potentially best-in-class solution for PGHD.
VISEN’s strategy to secure early regulatory approval and local production capacity is likely to support rapid uptake once the therapy is introduced into the Chinese market. Furthermore, the domestic manufacturing infrastructure established in partnership with WuXi Biologics could serve as a launchpad for future expansion into other Asia-Pacific markets, thereby boosting the regional availability of this next-generation growth hormone therapy.
The launch of technology transfer for lonapegsomatropin and the construction of a novel dual-chamber lyophilization line mark important inflection points in the WuXi-VISEN collaboration. These developments pave the way for not only the commercial production of a transformative therapy but also broader advancements in China’s biopharmaceutical manufacturing capabilities.
As the companies deepen their partnership over the coming years, they are likely to explore additional areas of collaboration, including pipeline expansions and potential co-development opportunities in other therapeutic categories.
With VISEN Pharmaceuticals’ deep clinical and regulatory expertise in endocrine diseases and WuXi Biologics’ comprehensive, globally recognized CDMO platform, the two organizations are well positioned to bring more high-impact therapies to Chinese patients—and potentially, the world.
WuXi Biologics and VISEN Pharmaceuticals have initiated the commercial technology transfer for lonapegsomatropin at a state-of-the-art facility in Chengdu, which will also house China’s first dual-chamber lyophilized formulation line. The project, targeting local production by 2028 following expected regulatory approval in 2025, reflects both companies’ strategic commitment to improving access to innovative endocrine therapies for Chinese patients
