Shanghai, China, May 23, 2023 - Shanghai Ark Biopharmaceutical Co., Ltd. (hereinafter referred to as "ArkBio") and Wuxi STA (hereinafter referred to as "STA") jointly announced that they have officially signed a commercial supply cooperation agreement for the new drug Aisiwei^® (generic name: ziresovir) against respiratory syncytial virus (RSV) infection. This cooperation represents an important and solid step in the commercialization strategic layout of ArkBio. Dr. Jim Wu, Chairman of Board and CEO of ArkBio, and Dr. Chen Jinling, Senior Vice President and Head of the Formulation Business of STA, jointly attended this signing ceremony.

Aisiwei^® is a brand-new small molecule inhibitor of the RSV fusion protein and is the world's first RSV antiviral drug that has successfully completed Phase III registrational clinical trials. At the same time, Aisiwei^® is the first innovative drug for children discovered, developed, and expanded globally in China. This product has received support from the national "13th Five-Year Plan" "Major New Drug Creation" Science and Technology Major Project and is also the first non-oncology innovative drug recognized as a "Breakthrough Therapy Variety" by the National Medical Products Administration. Currently, the new drug application of Aisiwei^® was accepted by the National Medical Products Administration (NMPA) at the end of 2022 and has been included in the "Priority Review and Approval" process. The drug is expected to become the world's first clinically approved specific anti-RSV virus infection drug. ArkBio is committed to realizing the commercialization of Aisiwei^® as soon as possible to benefit a large number of patients.

As a long-term partner of ArkBio, STA provided comprehensive services for the custom formulation R&D and production of Aisiwei^® during its development process. In the first quarter of 2023, STA Waigaoqiao factory successfully passed the pre-approval inspection (PAI) of Aisiwei^® by the NMPA, which also provided a strong guarantee for the early approval and listing of this new drug in China. In the future, the two sides will continue to strengthen cooperation in various aspects such as custom formulation R&D and commercial production.

Dr. Jim Wu, Chairman of Board and CEO of ArkBio, said: "ArkBio is about to become an innovative biopharmaceutical enterprise with both clinical R&D and commercialization capabilities. I am very glad to further expand cooperation with STA at such an important stage. I believe that in the upcoming commercial production and supply, with the powerful platform capabilities and industry experience of STA and through the close cooperation of both sides, we can complete the production after the listing of Aisiwei® with high quality and efficiency and benefit a large number of RSV patients as soon as possible."

Dr. Chen Minzhang, Co-CEO of WuXi AppTec and CEO of STA, said: "I am very glad to deepen cooperation with ArkBio. This is another powerful manifestation of STA's 'end-to-end' platform continuously empowering customers and winning high recognition. The cooperation between ArkBio and STA in the Aisiwei® project has been highly effective. In the future, we will continue to rely on the industry-leading enabling platform, the quality system that meets international standards, and sufficient formulation production capacity to accelerate and ensure the commercialization process of Aisiwei® and benefit more patients as soon as possible."

About ArkBio·

ArkBio is a global biotech company focusing on discovery and development of innovative drugs for unmet medical needs, especially in the therapeutic areas of respiratory, infectious and pediatric diseases. Since its inception in 2014, the company has established core technology platforms and built an innovative and highly differentiated R&D pipeline through in-house R&D efforts and external collaborations. This strong R&D pipeline program includes innovative clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global clinical development. As one of the core assets, ziresovir is the first direct-acting RSV antiviral drug that has been developed by ArkBio. 

ArkBio has established strategic partnerships with several global pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture investment institutions. 

For more information about the company, please visit our website: www.arkbiosciences.com

Investor Inquiries：IR@arkbiosciences.com

About WuXi STA

Wuxi STA is a subsidiary of WuXi AppTec, with research and development and manufacturing bases in Asia, North America, and Europe. Serving the life sciences industry, STA possesses outstanding capabilities and technological platforms for the research and development and manufacturing of innovative chemical drugs. As a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) in the field of new drug development, STA is committed to providing efficient, flexible, and high-quality one-stop solutions for global partners to support the research and development and manufacturing of small molecules, oligonucleotides, peptides, and various complex chemical conjugated drugs. 

For more information, please visit the company's website: www.stapharma.com.cn