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WuXi Biologics, a leading global CRDMO, and VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, announced that they will launch the technology transfer for the commercial production of VISEN Pharmaceuticals’ 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, an innovative formulation technology designed to significantly enhance drug stability and clinical administration convenience.
Building on their initial strategic agreement in December 2023 for the technology transfer of lonapegsomatropin, 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 paediatric 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.
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.”
WuXi Biologics 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.
Virogen is a clinical stage biotechnology company with expertise in both US and Asia. Its leading development program is VG712, invented at NIH by a pioneer in immunotoxin, Dr. David Neville.
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