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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
Shanghai Ark Biopharmaceutical Co., Ltd. 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).
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Ark Biopharmaceutical Announces NMPA Acceptance and Priority Review of New Drug Application for Ziresovir for Treatment of RSV Infection
China’s National Medical Products Administration (NMPA) has formally accepted and granted Priority Review of its New Drug Application (NDA) for ziresovir (AK0529) for treatment of respiratory syncytial virus (RSV) infection.
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Ark Biopharmaceutical Presents Positive Results in Phase 3 AIRFLO Study of Ziresovir in RSV-Infected Hospitalized Infants at 12th International RSV Symposium
The study met both the primary endpoint of reduction in signs-and-symptoms (S&S) score on day 3 of treatment, and the key secondary endpoint of reduction in viral load on day 5, compared with placebo
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Ark Biopharmaceutical Announces Positive Results of Phase 3 Study with Ziresovir in Infants and Children Hospitalized with Respiratory Syncytial Virus Infection
The first antiviral drug successfully completing a pivotal phase 3 study in this patient population
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Ark Biopharmaceutical Announces Completion of Patient Enrollment and Dosing in AIRFLO, a Phase III Registration Trial of Ziresovir for Treatment of Respiratory Syncytial Virus Infection
This is the first time ever that a phase III clinical trial of an RSV-specific therapeutic has been completed. Topline results are expected to be available in the first half of 2022.
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Ark Biopharmaceutical Enters Into Exclusive License Agreement For Novel ADHD Treatment AZSTARYS® In Greater China, With Affiliate Of Gurnet Point Capital
SHANGHAI, December 28, 2021 -- Shanghai Ark Biopharmaceutical Co., Ltd., an innovative biopharmaceutical company with a depth of expertise in pediatric drug development, today announced that Ark Biopharmaceutical Limited, a wholly-owned subsidiary of ArkBio, entered into an exclusive license agreement with Commave Therapeutics, SA (Commave), an affiliate of Gurnet Point Capital (GPC), a private investment firm focused on the life sciences and medical technology sectors. The license agreement provides for exclusive rights to develop, manufacture, and commercialize the first-in-class once-daily attention deficit hyperactivity disorder (ADHD) treatment AZSTARYS® (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
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