WuXi Biologics and VISEN Pharmaceuticals have announced the initiation of technology transfer for the commercial production of lonapegsomatropin at the former’s new microbial manufacturing site in Chengdu, China.
Headquartered in China, WuXi Biologics is a contract research, development and manufacturing organisation (CRDMO).
The collaboration, aimed at enhancing drug stability and ease of administration, will also focus on establishing China’s first dual-chamber lyophilised production line. This development follows their initial agreement in December 2023.
VISEN Pharmaceuticals CEO and executive director Pony Lu said: “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.”
Lonapegsomatropin, a long-acting growth hormone for treating paediatric growth hormone deficiency (PGHD), offers a weekly therapeutic option for affected children. Already approved in the US and Europe, the drug is anticipated to receive Chinese regulatory approval this year, with local production expected by 2028.
WuXi Biologics CEO Chris Chen said: “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 recognised process development expertise and cGMP-compliant quality systems, we will deliver a fully integrated solution for VISEN Pharmaceuticals from technology transfer to scaled manufacturing.”
Separately, WuXi Biologics has begun construction of the new microbial manufacturing facility in Chengdu’s Wenjiang district. Covering 95,000m2, the site will include both drug substance and product facilities, capable of producing a diverse range of modalities such as peptides, antibody fragments, and virus-like particles.
The facility is set for GMP release by the end of 2026 and will initially feature a 15,000L fermenter with plans to expand to 60,000L capacity.
It aims to exceed a manufacturing capacity of over 10 million vials annually.
WuXi Biologics will implement its microbial expression platform EffiX to ensure high yield and consistent quality. Designed with energy efficiency in mind, the facility is expected to support sustainability goals while maintaining regulatory compliance and operational efficiency.
Additionally, WuXi Biologics has entered into a partnership with Virogen Biotechnology to facilitate the global market approval of VG712, the latter’s leading clinical-stage asset. This collaboration involves comprehensive services including technology transfer and process validation for both drug substances and products.
