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2026-10-13

ArkBio Announces FDA Clearance to Initiate Phase II Trial of AK0406 for Influenza Prevention

Shanghai, October 13, 2026 — Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States.

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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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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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