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About ArkBio

We are committed to our mission of driving R&D through innovation, addressing unmet medical needs of patients worldwide, building a healthy work environment for our employees, and creating value for our investors, partners and society.

AK0529

AK0529 (ziresovir) is a novel small molecule inhibitor targeting RSV fusion protein. It is the world's first RSV specific antiviral drug to achieve positive results in Phase III clinical trials and has been granted the "breakthrough therapy" designation by the Chinese National Medical Products Administration. Filing of new drug application (NDA) is expected in 1H2025.
AK0901

Authorized for marketing in the United States in July 2021, AK0901 (Azstarys) is a best-in-class drug in the methylphenidate class for treatment of children with ADHD. It offers significant advantages in terms of novel mechanism of drug delivery, fast onset, longer duration and ease of administration. Currently it is being tested in a Phase III clinical trial in Chinese pediatric patients.
AK3280

AK3280 is a new generation broadly active anti-fibrotic drug optimized based on the pirfenidone chemical scaffold with significantly improved safety, tolerability, and superior efficacy, making it a potential best-in-class drug for treatment of fibrotic diseases. A Phase II clinical trial in IPF patients is ongoing.
AK0610

AK0610 is a human monoclonal antibody targeting the pre-fusion F protein of RSV. With the highly potent neutralization activity in preclinical models and a long half-life that would provide lasting protection from RSV, it has high potential to become a best-in-class drug of RSV preventive medicine. Currently a Phase I clinical trial in China is being completed.
AK0705

AK0705 is a potential first-in-class neutrophil inhibitor for treating inflammatory respiratory diseases such as COPD. It has a novel mechanism of action of reversible covalent binding, exhibiting excellent inhibitory activity at the picomolar level. Currently it is under IND-enabling development.

R&D Expertise

ArkBio is committed to transformative R&D of drugs for the treatment of respiratory and pediatric diseases that provide patients with safer and more efficacious therapeutic options. Through continuous scientific innovation and technological improvements, we have achieved significant progress in multiple disease areas.

RSV

Respiratory Syncytial Virus

IPF

Idiopathic Pulmonary Fibrosis

COPD

Chronic Obstructive Pulmonary Disease

ADHD

Attention Deficit Hyperactivity Disorder

Respiratory Syncytial Virus

Respiratory syncytial virus (RSV) is the most important viral pathogen causing acute lower respiratory tract infections in children under 5 years old worldwide, and it is the primary factor leading to hospitalization due to viral respiratory infections in infants and young children. It is estimated that there are approximately 33 million cases of RSV associated acute lower respiratory tract infection among children under the age of 5 globally, resulting in approximately 3.6 million hospitalizations and 100,000 deaths. Currently, there is no effective anti-viral treatment available for RSV.

Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disorder characterized by fibrosis of the lungs from an unknown cause. It is estimated that the number of people worldwide suffering from IPF increased from 1.4 million to 1.7 million between 2015 and 2022. IPF has an insidious onset, and the disease progresses continuously and irreversibly thereafter. The median survival time of patients is only 3-5 years, and the estimated five-year survival rate is about 20%, which is lower than many types of cancer. The existing therapies have limited effectiveness with poor tolerability and significant side effects (such as gastrointestinal intolerance, phototoxicity, and hepatotoxicity), which often lead to treatment discontinuation.

Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.COPD patients are at high-risk for heart disease, lung cancer, and poor quality of life. In 2020, there were approximately 218 million COPD patients worldwide, of which around 114 million were in China. The incidence in China is expected to increase to 153 million patients by 2030. There is currently no cure for COPD, and existing therapy may only alleviate symptoms.

Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is a common chronic neurodevelopmental disorder that begins in childhood and can continue into adult life. Its main features are attention deficit and/or hyperactive impulses that are not commensurate with developmental levels. It is estimated that the global prevalence of ADHD in children is about 7.2%, and in Chinese children and adolescents is 6.3%. While the overall prevalence of ADHD is high, the awareness of the condition is low and consultation rate for ADHD in children is under 10% in China.

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Tel：+86-21-50681677
Address：No. 25, Lane 388, Shengrong Road, Pudong
New Area, Shanghai, China
E-mail：ir@arkbiosciences.com

Tel：+86-21-50681677
Address：No. 25, Lane 388, Shengrong Road, Pudong
New Area, Shanghai, China
E-mail：ir@arkbiosciences.com

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