| Date | Title | Description |
| 14.08.2026 | ArkBio's RSV Antiviral Drug Ziresovir Receives FDA Approval for Phase II Clinical Trial | SHANGHAI, Aug. 14, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has approved ziresovir (AK0529) for a phase II clinical trial in the seve... |
| 13.08.2026 | ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis | SHANGHAI, Aug. 13, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the Investigational New Drug (IND) application for AK0406 injection, the company's first long-acting antiviral drug‑F... |
| 24.07.2026 | ArkBio Completes all Cohort Dosing in Australian Phase I Trial with Influenza AFC Drug AK0406 | SHANGHAI, July 24, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that all cohorts of healthy volunteers have been dosed in an Australian Phase I trial with AK0406, a novel long-acting ant... |
| 10.04.2026 | ArkBio Completed Dosing of First Cohort in Australian Phase I Trial of Antiviral Drug-Fc Conjugate Drug AK0406 | SHANGHAI, April 10, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the first cohort of healthy volunteers has been dosed in a phase I clinical trial of AK0406, a novel long-acting ant... |
| 12.02.2026 | Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF | SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AK3280, a ... |
| 08.01.2026 | Ark Biopharmaceutical Receives China Marketing Authorization for Aizhida for the Treatment of ADHD | SHANGHAI, Jan. 8, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidat... |
| 06.01.2026 | Ark Biopharmaceutical Receives China Marketing Authorization for Azstarys® for the Treatment of ADHD | SHANGHAI, Jan. 6, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidat... |
| 30.10.2025 | ArkBio Initiates Phase II Clinical Trial of AK0610, a Preventive Monoclonal Antibody for Respiratory Syncytial Virus Infection | SHANGHAI, Oct. 30, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced the initiation of a Phase II clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory s... |
| 16.07.2025 | ArkBio's Ziresovir Included into Pediatric RSV Drug Priority List by WHO | SHANGHAI, July 16, 2025 /PRNewswire/ -- In the newly released "Paediatric drug optimization for respiratory syncytial virus (PADO-RSV) meeting report" by Global Accelerator for Paediatric formulations (GAP-f), the World Health Org... |
| 18.06.2025 | A New Dawn in Oncology and ADHD Treatment: Abbisko and ArkBio Lead the Charge | In the ever-evolving landscape of medicine, two companies are making headlines: Abbisko Therapeutics and ArkBio. Both are pushing boundaries, seeking to redefine treatment paradigms in oncology and ADHD. Their recent advancements signal hop... |
| 16.06.2025 | ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA | SHANGHAI, June 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstar... |
| 16.05.2025 | ArkBio Announces Positive Phase II Results of AK3280 for Treatment of Idiopathic Pulmonary Fibrosis (IPF) | SHANGHAI, May 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced positive top-line Phase II study results for its novel anti-fibrotic drug AK3280 in treatment of idiopathic pulmonary fibro... |
| 17.04.2025 | A New Dawn in Pediatric Health: Ziresovir's Breakthrough Against RSV | In the world of pediatric medicine, a storm brews. Respiratory syncytial virus (RSV) is a formidable foe, striking down infants and young children with relentless ferocity. Each year, millions of cases emerge, leading to countless hospitali... |
| 16.04.2025 | The Lancet Child & Adolescent Health Publishes Phase III Trial and 24-Month Follow-Up Results of Ziresovir for RSV in Infants Under 6 Months | SHANGHAI, April 16, 2025 /PRNewswire/ -- The Lancet Child & Adolescent Health, a leading international journal in pediatric and adolescent medicine, has published the Phase III clinical trial results of ziresovir, a novel RSV-targeted a... |
| 24.03.2025 | ArkBio Announces the Completion of Phase III Clinical Study for AK0901 in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in China | SHANGHAI, March 24, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced the successful completion of the Phase III clinical study of AK0901, a novel drug for the treatment of attention deficit ... |
| 26.11.2024 | ArkBio's Breakthrough in RSV Prevention: A New Hope for Vulnerable Infants | In the world of medicine, every breakthrough is a beacon of hope. Ark Biopharmaceutical Co., Ltd. (ArkBio) has recently illuminated the path forward with its Phase 1 clinical study of AK0610, a monoclonal antibody aimed at preventing respir... |
| 26.11.2024 | The Race Against Obesity and RSV: Innovations in Biotech | In the world of biotechnology, two companies are racing to tackle pressing health issues: obesity and respiratory syncytial virus (RSV). Pep2Tango Therapeutics and ArkBio are making strides that could change the landscape of treatment for m... |
| 25.11.2024 | ArkBio Announces Successful Completion of Enrollment and Dosing for Phase 1 Clinical Study of AK0610, a Preventive Antibody Against Respiratory Syncytial Virus Infection | SHANGHAI, Nov. 25, 2024 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") announced today the successful enrollment and dosing of all participants in a Phase 1 clinical study of AK0610, a fully human monoclonal a... |
| 26.09.2024 | ArkBio Announces Publication of Phase 3 Clinical Trial Results of Ziresovir for the Treatment of RSV Infection in The New England Journal of Medicine | SHANGHAI, Sept. 26, 2024 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), a clinical stage biopharmaceutical company focused on the development of therapeutics in respiratory, infectious and pediatric diseases,... |
| 27.08.2024 | ArkBio Presented at the 8th Annual IPF Summit and Announced Completion of Patient Enrollment for Phase 2 Clinical Trial of AK3280, a Next-Generation Drug for IPF Treatment | BEIJING, Aug. 27, 2024 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), a privately held, clinical-stage biopharmaceutical company today announced that Dr. Jim Wu, Chief Executive Officer of ArkBio, gave an ora... |
| 23.11.2023 | Ark Biopharmaceutical Receives IND Approval from NMPA for AK0610, a Respiratory Syncytial Virus Neutralizing Antibody | SHANGHAI, Nov. 23, 2023 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announces that it had received IND approval from National Medical Products Administration (NMPA) for a novel antibody drug AK0610. This antibody drug ... |
| 16.03.2023 | 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... | 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-de... |
