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 severely ill RSV...
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‑Fc conjugate (AFC)...
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 antiviral-Fc conjugate...
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 antiviral drug-Fc...
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 novel anti-fibrotic...
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 Serdexmethylphenidate Chloride and...
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 Serdexmethylphenidate Chloride and...
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 syncytial virus...
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 Azstarys...
ArkBio Announces Positive Phase II Results of AK3280 for treatment of Idiopathic Pulmonary Fibrosis (IPF)
SHANGHAI, May 7, 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 fibrosis (IPF). The...