Shanghai Ark Biopharmaceutical Co., Ltd.

Oct. 12, 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. Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and variability in individual immune response can limit vaccine protection, particularly among older adults and people who are immunocompromised. Additional preventive approaches could help address these unmet needs. According to the U.S. Centers for Disease Control and Prevention (CDC), despite the availability of influenza vaccines, the 2025–2026 influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States. AK0406 is a novel AFC drug discovered and developed by ArkBio. By precisely conjugating multiple potent small-molecular antivirals to an antibody Fc domain, AK0406 is designed to combine direct antiviral activity with Fc-mediated immune clearance to prevent influenza, with potential therapeutic applications. In preclinical studies, AK0406 demonstrated broad-spectrum and highly potent antiviral activity against both influenza A and B strains. It has also been optimized for its pharmacokinetics (PK) properties and GMP manufacturing process. In February 2026, AK0406 received approval from a Human Research Ethics Committee (HREC) in Australia to initiate a phase I clinical trial. In July 2026, ArkBio announced that enrollment and dosing of healthy adult participants had been completed across all cohorts and that the study had entered the follow-up phase. In August 2026, National Medical Products Administration (NMPA) of China cleared the IND application for AK0406 for influenza prevention. The FDA clearance marks a further milestone in the global clinical development of AK0406. The U.S. phase II clinical trial will be a multicenter, randomized, double-blind, placebo-controlled study in adults during an influenza season. Its primary objective is to evaluate AK0406 for influenza prevention. The study will also assess safety, tolerability, PK and immunogenicity. The resulting data will inform AK0406's future global development strategy. ArkBio plans to continue discussions with the FDA and the Center for Drug Evaluation (CDE) of China's NMPA to advance phase II development in the United States and China. Through parallel development pathways, the company aims to accelerate the AK0406 program as an additional option for influenza prevention, addressing challenges posed by viral evolution and limited vaccine protection, including in populations at high-risk of severe disease. ArkBio is a commercial-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for treatment of respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated innovative R&D pipeline through internal innovation and strategic collaborations. Key R&D pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive phase III results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase II results for treatment of idiopathic pulmonary fibrosis, currently in a phase III trial; AK0901, approved and commercialized in China for ADHD treatment. The company also has multiple first-in-class or best-in-class innovative drug candidates under clinical or preclinical development.、、 ArkBio has established strategic partnerships with multinational and domestic pharmaceutical companies including Roche, Genentech, and Qilu Pharmaceutical; leading academic institutions including The Scripps Research Institute and the Institute of Microbiology, Chinese Academy of Sciences; and other domestic and international biotech companies and CROs. The content above comes from the network. if any infringement, please contact us to modify.

SHANGHAI, Aug. 12, 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) 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. AK0406 is a new generation, long-acting antiviral agent discovered and developed by ArkBio. By precisely conjugating a highly potent antiviral small molecule with an antibody Fc fragment, AK0406 is designed to provide sustained pre‑ and post‑exposure prophylaxis and potential therapeutic benefits, addressing the high unmet needs for influenza prevention during peak seasons. Preclinical data show that AK0406 exerts broad-spectrum, high-potency activity against both influenza A and B viruses, maintains immune effector function, and provides prolonged exposure. Compared with other AFC molecules, AK0406 is engineered to offer an optimized profile for both prophylaxis and treatment of influenza infection. On the global clinical development front, ArkBio received approval from the Australian Human Research Ethics Committee (HREC) in February 2026 to initiate a phase I clinical trial of AK0406. Enrollment and dosing of healthy adult volunteers in all cohorts have been completed in Australia, and the trial has now entered the follow-up phase. Influenza remains a critical global public health challenge. Current flu preventive measures centered on seasonal vaccines face significant limitations, including the inability to effectively address antigenic drift, uncertainty in annual strain prediction and matching, and substantially reduced protective efficacy among elderly and immunocompromised populations, leaving significant unmet clinical needs. ArkBio will maintain close interactions with the CDE to advance the clinical development of AK0406 in China, while continuing the follow-up work of the ongoing phase I study in Australia. By pursuing a parallel, dual‑track development pathway in China and globally, the company aims to accelerate the clinical program to deliver a safer, more effective, and convenient solution for influenza prevention worldwide. About ArkBio ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations. Key pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive pivotal phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results in idiopathic pulmonary fibrosis, is currently in phase 3 registrational trials; AK0901, approved and commercialized in China for ADHD treatment. The company also has multiple first-in-class or best-in-class innovative candidates in clinical or preclinical development. ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions including The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences, Qilu Pharmaceutical, as well as other domestic and international biotech companies and CROs. For more information, please visit: Investor Inquiries: [email protected] SOURCE Shanghai Ark Biopharmaceutical Co., Ltd. 21% more press release views with Request a Demo

Aug. 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). RSV is the leading pathogen of lower respiratory tract infections (LRTIs) in infants and young children globally, causing approximately 33 million LRTI cases, 3.6 million hospitalizations, and more than 100,000 deaths annually. Severely ill RSV infected infants often require admission to the PICU for intensive care such as respiratory support, with rapid disease progression, high risk and a heavy medical burden. There is currently no approved RSV-specific antiviral therapy worldwide; clinical management remains limited to symptomatic and supportive care, such as oxygenation, leaving an urgent unmet need for effective antiviral treatment in hospitalized RSV infected patients with severe diseases. Ziresovir is the first direct RSV antiviral drug to successfully complete a phase III clinical trial with positive results. The clinical study in 1-24 months age patients conducted in China demonstrated that ziresovir can significantly reduce viral load, accelerate the resolution of respiratory symptoms, and significantly lower the risk of recurrent wheezing and asthma over 24-month follow-up period, with a favorable safety profile. Key findings from the clinical study have been published in The New England Journal of Medicine and The Lancet Child & Adolescent Health. In 2025, ziresovir was included as the only therapeutic drug in the WHO's Paediatric Drug Optimization for Respiratory Syncytial Virus publication. The newly approved phase II clinical trial marks the extension of ziresovir's clinical development into the most critically ill RSV patients, representing a key milestone in the clinical development of ziresovir globally. The approved multicenter, randomized, double-blind, placebo-controlled phase II clinical trial will focus on severely ill RSV infected infants requiring hospitalization in PICU, one of the most critical RSV patient populations with the most urgent clinical treatment needs. This clinical trial is designed to evaluate clinical efficacy of ziresovir, especially the length of oxygen treatment and sustained recovery time, providing the clinical basis for the future registrational trials. ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations. Key pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results in idiopathic pulmonary fibrosis, currently in phase 3 registrational trials; AK0901, approved and commercialized in China for ADHD treatment. The company also has multiple first-in-class or best-in-class innovative drug candidates in clinical or preclinical development. ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions including The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences, Qilu Pharmaceutical, as well as other domestic and international biotech companies and CROs. The content above comes from the network. if any infringement, please contact us to modify.