WUXI, China, Oct. 2, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner, Amicus Therapeutics ("Amicus") (Nasdaq:FOLD), on receiving U.S. FDA's approval for Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This two-component therapy is indicated for those adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).

Pombiliti™, a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), was started at WuXi Biologics in 2012 with just an initial concept and now realizes commercialization enabled by WuXi Biologics' proprietary integrated technology platform and unparalleled manufacturing capacity. As the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier, WuXi Biologics is now providing commercial manufacturing services for Pombiliti™ at five facilities across its global manufacturing network.

Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, commented, "This approval marks a major milestone for the Pompe disease community in the United States. Bringing this new treatment option to market has required immense dedication and strong partnership between the WuXi Biologics team and Amicus, relying on our shared dedication to patients and our ability to execute on our vision to bring high quality therapies to the rare disease community. Over many years of hard work, our joint efforts have brought this medicine from an idea, to a molecule, to clinical manufacturing and commercial supply, delivering on our commitment to people living with late-onset Pompe disease."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're honored to enable Amicus to achieve this great milestone, which we've been looking forward to for over 11 years. This close partnership not only showcases our successful strategy, 'follow the molecule', but also inspires us to accelerate the discovery, development and manufacturing of more rare disease biologic therapeutics for global partners. I am confident that the collaboration between our two companies, both of which share a passion for patients, will achieve greater successes in the journey of benefiting global patients with rare diseases."

About Pompe Disease

Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to accumulation of glycogen in cells, which is believed to result in the clinical manifestations of Pompe disease. Pompe disease ranges from a rapidly deteriorating infantile form with significant impact to heart function, to a more slowly progressive, late-onset form primarily affecting skeletal muscle and progressive respiratory involvement. Late-onset Pompe disease can be severe and debilitating with progressive muscle weakness throughout the body that worsens over time, particularly skeletal muscles and muscles that control breathing.

About Pombiliti + Opfolda

Pombiliti + Opfolda, is a two-component therapy that consists of cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that facilitates high-affinity uptake through the M6P receptor while retaining its capacity for processing into the most active form of the enzyme, and the oral enzyme stabilizer, miglustat, that's designed to reduce loss of enzyme activity in the blood.

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 June 30, 2023, WuXi Biologics is supporting 621 integrated client projects, including 22 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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