Ark Biopharmaceutical and Calibr, a Division of Scripps Research, Announce Co-development Collaboration on AK0705, a Potential First-in-Class Drug for Treating a Broad Spectrum of Respiratory Diseases, Including COPD

• Ark Biopharmaceutical will lead development activities for AK0705 with the goal of initiating clinical studies in 2024.
• Calibr will continue to collaborate in the development of AK0705.
• The collaboration is an extension of the current co-development collaboration.

SHANGHAI, March 16, 2023 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio), a global biopharmaceutical company focusing on discovery and development of innovative drugs for unmet medical needs in pediatric and respiratory disease areas, today announced that it has renewed its co-development collaboration with Calibr, a division of Scripps Research. The collaboration centers on AK0705, a potential first-in-class drug targeting an enzyme that plays an important role in respiratory inflammation. AK0705 is being developed to treat a broad spectrum of respiratory diseases, including chronic obstructive pulmonary disease (COPD).

Under terms of the agreement, ArkBio will lead the preclinical development activities, with Calibr contributing its expertise to jointly guide the program forward. This renewed collaboration extends an ongoing collaboration that identified AK0705 as the pre-clinical candidate (PCC). Upon completion of the next stage of development, AK0705 is expected to enter human clinical studies in 2024.

"We are delighted to continue our collaboration with Calibr and take AK0705 forward together," said Dr. Jim Wu, Chairman and CEO of ArkBio. "Our teams have made great progress so far, and I am confident that we will continue to unlock the value of AK0705 as a well-differentiated therapeutic option for treating respiratory diseases with high unmet needs."

"New therapies are desperately needed for respiratory diseases resulting from chronic inflammation—the hundreds of millions of people suffering from these disorders globally have few options," said Dr. Peter Schultz, CEO and President of Scripps Research and Calibr. "Through novel chemistry, AK0705 has potential to be a targeted therapy that corrects an enzyme imbalance that underlies multiple respiratory disorders. ArkBio has been an exemplary collaborator, and we look forward to progressing this therapy toward human clinical trials."

About AK0705

AK0705 is a potential first-in-class drug candidate targeting a key enzyme activated under inflammatory conditions. It demonstrated a picomolar potency via a novel reversible covalent binding mechanism.

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. 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: [email protected]

About Calibr and Scripps Research

Calibr is a first-of-its kind non-profit translational research institute dedicated to creating the next generation of medicines. Part of Scripps Research situated in the heart of San Diego's Torrey Pines Mesa biomedical research hub, Calibr is uniquely positioned to create and proliferate innovative collaborations. Calibr has created a broad therapeutic pipeline extending from early-stage discovery through clinical-ready programs, including candidate medicines ranging from small molecules and peptides to biotherapeutics and cell-based therapies.

Scripps Research is ranked one of the most influential scientific institutions in the world for its impact on innovation. A non-profit research organization, Scripps Research expands basic knowledge in the biosciences and uses these fundamental advancements to develop profound innovations that improve well-being. Scripps Research scientists lead breakthrough studies that address the world's most pressing health concerns, accelerating the creation and delivery of medical breakthroughs to better human health across the globe. Its educational and training programs mold talented and committed students and postdocs into the next generation of leading scientists.

For more information about Calibr and Scripps Research visit www.calibr.org and www.scripps.edu. Follow @ScrippsResearch on Twitter, Facebook or LinkedIn.

SOURCE Shanghai Ark Biopharmaceutical Co., Ltd.