SHANGHAI, CHINA, May 23, 2023 – WuXi STA, a subsidiary of WuXi AppTec, and Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced a strategic partnership for the commercial supply of ziresovir, a novel treatment of respiratory syncytial virus (RSV) infections. As a trusted partner, WuXi STA will support ArkBio with the commercial production of ziresovir after its launch in China. The signing ceremony was attended by Dr. Jim Wu, Chairman and CEO of ArkBio, and Dr. Jinling Chen, SVP and Head of Pharmaceutical Development and Manufacturing Services of WuXi STA.
ArkBio is a biopharmaceutical company dedicated to addressing unmet clinical needs in pediatric and respiratory diseases. Arkbio’s innovative drug, ziresovir, is a First-in-Class small molecule RSV fusion (F) protein inhibitor and is the first oral RSV antiviral drug successfully completed the phase III clinical trial globally. Currently, ziresovir’s New Drug Application (NDA) has been accepted and granted Priority Review by the China NMPA. Ziresovir is potentially the world’s first-approved anti-RSV therapeutic drug.
As a long-term partner of ArkBio, WuXi STA has provided customized formulation R&D and manufacturing services for ziresovir during its development process. In the first quarter of 2023, WuXi STA’s Waigaoqiao site successfully passed the NMPA’s Pre-Approval Inspection (PAI) for ziresovir, providing the strong support for its upcoming NDA approval in China. According to the agreement, both companies will continue to strengthen the collaboration in various aspects from customized formulation R&D to commercial manufacturing.
Dr. Jim Wu, Chairman and CEO of ArkBio, said: “ArkBio is about to become a biopharmaceutical company with both R&D and commercial capabilities. We are delighted to expand our cooperation with WuXi STA at this crucial stage. We believe that with WuXi STA’s strong platform capabilities and industry experience, through our close collaboration, ziresovir will have an efficient and robust supply chain after it goes to market, and will soon bring benefits to a broad population of RSV patients.”
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, stated: “We are excited to deepen our cooperation with ArkBio, which demonstrates the capability of our CRDMO platform. Through the successful collaboration between ArkBio and WuXi STA, we will continue to leverage our industry-leading platform with broad capability and extensive capacity, as well as the global standard quality system, empowering the commercialization process of ziresovir to benefit a greater number of patients globally.”
About ArkBio
ArkBio is a global biopharmaceutical company focusing on discovery and development of innovative drugs for unmet medical needs, especially in pediatric and respiratory disease areas. Since its inception in 2014, the company has established core technology platforms and has created innovative drugs with global patent protection. Through in-house R&D efforts and external collaborations, the company has developed a promising and highly differentiated product pipeline. The core product, ziresovir, is the world’s leading anti-RSV therapeutic drug that has received a breakthrough designation from China’s regulatory authority NMPA, and currently under NDA review by the China CDE. Its another near-commercial asset is an attention deficit hyperactivity disorder (ADHD) drug AZSTARYS® recently approved by the FDA. ArkBio owns the right for its development and commercialization in Greater China. The pipeline programs also include a battery of clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global development.
ArkBio strives to become a leading global biopharmaceutical company with integrated technology platforms for drug discovery and development, manufacturing, and commercialization in pediatric and respiratory therapeutic areas.
For more information, please visit www.arkbiosciences.com
For investor relation please contact: IR@arkbiosciences.com
About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: https://sta.wuxiapptec.com/
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