相关临床试验
20
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2014
已完成
12
60.0%
尚未招募
3
15.0%
招募中
3
15.0%
终止
2
10.0%
暂无批准数据
- Shanghai Ark Biopharmaceutical Co., Ltd. announced FDA approval of ziresovir (AK0529) for a phase II clinical trial in severely ill RSV-infected infants, including those in the pediatric intensive care unit (PICU). - Ziresovir is the first direct RSV antiviral drug to successfully complete a phase III trial with positive results, demonstrating reduced viral load and accelerated symptom resolution. - RSV causes approximately 33 million lower respiratory tract infection cases, 3.6 million hospitalizations, and more than 100,000 deaths annually, with no approved RSV-specific antiviral therapy currently available worldwide. - The newly approved multicenter, randomized, double-blind, placebo-controlled phase II trial will evaluate clinical efficacy, particularly length of oxygen treatment and sustained recovery time.
- Shanghai Ark Biopharmaceutical has completed dosing of all healthy volunteer cohorts in its Australian Phase I trial of AK0406, a novel antiviral-Fc conjugate (AFC) drug for influenza prophylaxis. - AK0406 is designed to provide sustained pre- and post-exposure prophylaxis against both influenza A and B viruses, addressing limitations of seasonal vaccines such as antigenic drift and reduced efficacy in vulnerable populations. - Preclinical data demonstrate broad-spectrum, high-potency activity, retained Fc-mediated effector functions, and prolonged protective effect, supporting an optimized pharmacological profile for both prophylaxis and treatment. - The trial has now entered the follow-up phase, marking progress toward a potential new generation of influenza prevention that could offer a safer, more effective, and convenient solution globally.
- Shanghai Ark Biopharmaceutical received FDA clearance for its Investigational New Drug application for AK3280, enabling a Phase 2 proof-of-concept trial in idiopathic pulmonary fibrosis patients. - The multi-center, randomized, partially double-blind trial will evaluate the efficacy, safety, and pharmacokinetics of oral AK3280 compared to placebo and active controls. - Previous Phase 2 results in China showed AK3280 demonstrated statistically significant, dose-dependent improvements in forced vital capacity at Week 24 with favorable safety profile. - The drug addresses significant unmet medical needs in IPF, where current therapies have limited clinical benefit and are associated with gastrointestinal adverse events affecting patient adherence.
- China's National Medical Products Administration has approved Azstarys, a once-daily ADHD medication combining immediate-release and prodrug technologies for patients 6 years and older. - The approval addresses a significant unmet need in China, where ADHD affects approximately 6.4% of children and adolescents, totaling over 23 million individuals. - Azstarys demonstrated statistically significant improvements in core ADHD symptoms in a pivotal Phase III trial, becoming the first medication in China to provide both rapid onset and sustained symptom control. - The drug's unique dual mechanism positions it to reshape ADHD treatment paradigms in China, where current therapeutic options remain limited and many patients discontinue treatment due to suboptimal response or side effects.
- Shanghai Ark Biopharmaceutical has initiated a Phase II clinical trial of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus infection in healthy infants. - The multicenter, randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, and pharmacokinetics across five centers in China, led by Beijing Children's Hospital and West China Second Hospital. - AK0610 targets the pre-fusion F protein of RSV and demonstrates robust neutralizing activity across RSV variants, with preclinical data showing strong antiviral activity and an excellent safety profile. - The antibody's extended half-life may enable season-long protection with a single dose, addressing the significant healthcare burden of RSV infections in China's large infant population.
- The World Health Organization has included ziresovir (10mg) from Shanghai Ark Biopharmaceutical in its PADO-RSV priority list, making it the first and only RSV antiviral drug selected for the program. - RSV causes approximately 33 million lower respiratory tract infections, 3.6 million hospitalizations, and 101,400 deaths annually in infants and young children globally, with 97% of deaths occurring in low- and middle-income countries. - Ziresovir is a novel small-molecule RSV fusion protein inhibitor that has completed phase 3 pivotal clinical studies with positive results published in The New England Journal of Medicine and The Lancet Child & Adolescent Health. - ArkBio plans to expand ziresovir's clinical development globally and formulate accessibility plans for low- and middle-income countries to ensure reasonable pricing worldwide.
- ArkBio's novel anti-fibrotic drug AK3280 demonstrated significant improvement in lung function during Phase II trials for idiopathic pulmonary fibrosis, with the highest dose group showing a 209.4 mL increase in FVC. - Unlike current IPF treatments that merely slow disease progression, AK3280 achieved actual improvement in respiratory function while maintaining a favorable safety profile without the gastrointestinal issues associated with existing therapies. - The multicenter, randomized study conducted across 31 clinical sites in China positions AK3280 as a potential breakthrough for IPF patients, with preparations now underway for pivotal Phase III clinical trials.
- ArkBio has successfully completed Phase III clinical trials for AK0901, a novel methylphenidate-based drug for ADHD treatment, meeting all primary and secondary endpoints with statistical significance. - AK0901 combines immediate-release dexmethylphenidate with prodrug serdexmethylphenidate, offering improved symptom control and reduced blood concentration fluctuations compared to traditional treatments. - The drug addresses a significant unmet need in China, where ADHD affects 6.4% of children and adolescents—approximately 23 million individuals—with limited effective treatment options currently available.
