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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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2025-05-30

ArkBio and Partex Deepen Strategic Collaboration to Advance Novel ATR Inhibitor AK0658 Through AI-Driven Global Development

Shanghai, China – May 30, 2025 –Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), a leading Chinese biopharmaceutical company, today announced an expanded strategic collaboration with Partex, a leader in AI-driven pharmaceutical innovation, to jointly develop and out-license AK0658, a preclinical-stage ATR inhibitor demonstrating best-in-class potential. This follow-up partnership builds on the successful launch of their initial collaboration focused on autotaxin inhibitor AK0707.

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2025-05-16

ArkBio Announces Positive Phase II Results of AK3280 for Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Shanghai, May 16, 2025 — 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 study, led by Professor Huaping Dai of the Department of Pulmonary and Critical Care Medicine at China-Japan Friendship Hospital, Beijing, was conducted across 31 clinical sites in China.

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2025-04-16

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 — 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 antiviral drug developed by Shanghai Ark Biopharmaceutical Ltd. The article, titled "Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up", presents detailed subgroup analysis of infants under six months of age, following the primary results published in The New England Journal of Medicine in September 2024.

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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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