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2025-06-16

ArkBio's New Drug Application for ADHD Therapeutic Azstarys 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 Azstarys (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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2025-03-24

ArkBio Announces the Completion of Phase III Clinical Study for AK0901 in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in China

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 hyperactivity disorder (ADHD). This milestone represents a substantial step forward for ArkBio in the research and development of drugs for pediatric psychiatric disorders, potentially offering new treatment options and improved therapeutic outcomes for children with ADHD in China.

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2024-12-27

Shanghai Ark Biopharmaceutical Announces Strategic Collaboration with Partex for Partnership and Out-Licensing of Phase 1 Autotaxin Inhibitor AK0707

Shanghai, China – December 30, 2024 – Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), a clinical-stage, privately held biopharmaceutical company, today announced a strategic collaboration with Partex, a leader in AI-driven pharmaceutical innovation. This partnership aims to explore the full potential of ArkBio’s proprietary autotaxin inhibitor, AK0707, and identify the ideal partner for out-licensing the asset.

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2024-11-25

ArkBio Announces Successful Completion of Enrollment and Dosing for Phase 1 Clinical Study of AK0610, a Preventive Antibody Against Respiratory Syncytial Virus Infection

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 antibody designed to prevent respiratory syncytial virus (RSV) infection. This milestone marks a significant advancement in ArkBio' RSV portfolio, offering a new potential option for preventing RSV infection for vulnerable infants susceptible to RSV.

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2024-09-27

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, China September 27, 2024: Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), a clinical stage biopharmaceutical company focused on the development of therapeutics in respiratory, infectious and pediatric diseases, announced that the results of the phase 3 clinical trial of ziresovir, an oral drug for treatment of respiratory syncytial virus (RSV) infection in infants and young children, have been published as an original article entitled “Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus”in The New England Journal of Medicine (NEJM). This marks the first time that NEJM has published phase 3 clinical trial results of a direct-acting antiviral drug treating RSV infection.

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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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