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2026-08-14

ArkBio's RSV Antiviral Drug Ziresovir Receives FDA Approval for Phase II Clinical Trial

Shanghai, August 14, 2026 — 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 infected infant patients, including the ones in pediatric intensive care unit (PICU).

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2026-08-13

ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis

Shanghai, August 13, 2026 – 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) candidate for influenza prophylaxis, has been approved by the National Medical Products Administration (NMPA) of China, making AK0406 the first influenza AFC drug to enter clinical development in China.

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2026-07-24

ArkBio Completes all Cohort Dosing in Australian Phase I Trial with Influenza AFC Drug AK0406

Shanghai, July 24, 2026 – 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 (AFC) drug for influenza prophylaxis. The clinical trial has now entered the follow up phase.

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2026-04-10

ArkBio Completed Dosing of First Cohort in Australian Phase I Trial of Antiviral Drug-Fc Conjugate Drug AK0406

Shanghai, April 10, 2026 – 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 conjugate (ADFC) drug for influenza infection, following approval by the Human Research Ethics Committee (HREC) in Australia. This milestone marks the first-in-human (FIH) evaluation of AK0406 and an important step in the global clinical development of ArkBio’s influenza pipeline.

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2026-03-23

ArkBio Publishes the Molecular Mechanism of Ziresovir for Treatment of RSV in “PLOS Pathogens”

Shanghai, March 23, 2026 – Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), in collaboration with the research group led by Professor Wei Peng from the Innovative Center for Pathogen Research at Guangzhou National Laboratory, has published a mechanistic work of ziresvior in the international journal PLOS Pathogens . Utilizing cryo-electron microscopy (cryo-EM), the study reveals the molecular mechanism how the anti-respiratory syncytial virus (RSV) drug ziresovir interacts with the RSV fusion glycoprotein at the atomic levels, providing the direct structural information for the future development of RSV therapeutics.

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2026-02-12

Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF

Shanghai, February 12, 2026 —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 therapy for the treatment of idiopathic pulmonary fibrosis (IPF). This clearance enables ArkBio to initiate a Phase 2 proof-of-concept (PoC) clinical trial of AK3280 in the United States.

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2026-01-06

ArkBio Receives China Marketing Authorization for Aizhida for the Treatment of ADHD

Shanghai, China, January 6, 2026 – 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 Dexmethylphenidate Hydrochloride Capsules (Aizhida) for treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older in China.

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2025-10-30

ArkBio Initiates Phase II Clinical Trial of AK0610, a Preventive Monoclonal Antibody for Respiratory Syncytial Virus Infection

Shanghai, China, October 30, 2025 – 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 (RSV) infection. Building on ArkBio's previous experience and knowledge in development of RSV therapeutics, this milestone marks a major step forward in RSV prevention and enriches the company's innovative anti-RSV drug portfolio.

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2025-07-16

ArkBio' Ziresovir Included into Pediatric RSV Drug Priority List by WHO

Shanghai, China, July 16, 2025------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 Organization (WHO) host network, ziresovir (10mg) has been included in the PADO-RSV priority list. Ziresovir, developed by Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio"), is the first and only RSV antiviral drug to be included in the list. This is the first time WHO has included an anti-RSV drug developed from China in the paediatric drug optimization priority list.

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2025-06-16

ArkBio's New Drug Application for ADHD Therapeutic AK0901 Accepted and Granted Priority Review by China NMPA

Shanghai, China, June 16, 2025 — Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for AK0901 (serdexmethylphenidate/dexmethylphenidate extended-release capsules) and granted it Priority Review designation. The investigational therapeutic drug is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged six years and above.

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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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