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SHANGHAI, April 16, 2025 /PRNewswire/ -- 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.
RSV: An Urgent Unmet Medical Need
Respiratory syncytial virus (RSV) is a leading cause of hospitalization and mortality in children under six years old. With millions of cases annually worldwide, especially among infants under six months, RSV imposes a significant burden on families and healthcare systems. Current treatments are limited to symptomatic and supportive care, with no approved direct-acting antiviral therapies available.
Ziresovir's Phase III results mark a significant milestone, representing the first clinical validation of an antiviral's efficacy in hospitalized infants ≤6 months, and demonstrating long-term benefits in reducing recurrent wheezing and asthma.
Study Design
This multicenter, randomized, double-blind, placebo-controlled Phase III trial was conducted at 30 sites in 28 hospitals across China. The trial included two parts:
- Part 1 assessed safety and pharmacokinetics
- Part 2 evaluated clinical efficacy and antiviral effects
Infants were randomized in a 2:1 ratio to receive ziresovir or placebo for five days, with a 24-month follow-up. The latest publication focuses on infants aged six months or younger.
Key Findings
1. Significant Efficacy
- Improved Bronchiolitis Symptoms: By Day 3, ziresovir-treated infants had a 3.5-point reduction in Wang Bronchiolitis Clinical Score (WBCS), compared to 2.2 points in the placebo group—a 54.5% difference (p<0.001). Improvements in respiratory rate, wheezing, and retractions were also statistically significant (p<0.05).
- Rapid Viral Load Reduction: By Day 5, viral load decreased by 2.51 logâ‚â‚€ copies/mL in the treatment group, versus 1.87 logâ‚â‚€ in the placebo group (p=0.024), confirming ziresovir's antiviral activity.
- Faster Symptom Relief: Time to wheezing resolution (HR=1.53, p=0.021) and retraction relief (HR=1.49, p=0.018) were shorter in the treatment group. Hospital stay and oxygen use showed a reduction trend, though not statistically significant.
2. Long-Term Safety and Respiratory Health Benefits
- Favorable Safety Profile: Treatment-emergent adverse events (TEAEs) occurred in 18% of the treatment group vs. 11% in placebo. No drug-related severe adverse events or deaths were reported.
- Reduced Risk of Recurrent Wheezing and Asthma:
- Wheezing incidence was 3.6 times lower in the treatment group (0.18% vs. 0.65%, p=0.0048).
- Wheezing episodes were reduced by 2.6 times (1.2 vs. 3.1 episodes).
- Asthma rates were also lower (3% vs. 5%).
These long-term benefits suggest early antiviral intervention may reduce the risk of chronic respiratory conditions.
A New Era in RSV Treatment
Unlike existing RSV treatments focused solely on symptom relief, ziresovir is the first RSV-targeted antiviral therapy with demonstrated clinical efficacy in infants under six months—those most at risk of severe complications. These findings introduce a new therapeutic paradigm for RSV treatment and prevention of long-term sequelae.
The results were presented by Dr. Jim Wu, CEO of ArkBio, at the 13th International RSV Symposium in Brazil, receiving recognition from the global RSV research community.
Prof. Xin Ni, principal investigator of the Airflo study and professor at Beijing Children's Hospital, Capital Medical University, commented:
"This pivotal Phase III trial provides the first solid evidence of an effective antiviral treatment for RSV in high-risk infants. Following our initial publication in The New England Journal of Medicine, this deeper analysis in infants under six months published in The Lancet Child & Adolescent Health further validates ziresovir's safety, efficacy, and long-term benefit. We are proud of our team's commitment and look forward to bringing this drug to patients in China and worldwide."
For public readers, the article can be accessed at the following link:
https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(25)00067-7/fulltext
About Ziresovir
Ziresovir is a first-in-class, oral small-molecule inhibitor targeting the RSV fusion (F) protein. It prevents viral entry and cell-to-cell transmission by blocking syncytia formation, a hallmark of RSV infection. It is the first oral RSV antiviral to successfully complete a pivotal Phase III trial with positive results and has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of China.
About ArkBio
ArkBio is a global biotech company focused on developing innovative therapies for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house research and collaborations. Key assets include ziresovir, the first direct-acting RSV antiviral with positive pivotal phase III results globally, and AK0901, an FDA-approved pediatric ADHD therapy with commercialization rights in Greater China.
ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology, Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture investment institutions.
For more information about the company, please visit our website: www.arkbiosciences.com
Investor Inquiries: IR@arkbiosciences.com
SHANGHAI, April 16, 2025 /PRNewswire/ -- 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.
RSV: An Urgent Unmet Medical Need
Respiratory syncytial virus (RSV) is a leading cause of hospitalization and mortality in children under six years old. With millions of cases annually worldwide, especially among infants under six months, RSV imposes a significant burden on families and healthcare systems. Current treatments are limited to symptomatic and supportive care, with no approved direct-acting antiviral therapies available.
Ziresovir's Phase III results mark a significant milestone, representing the first clinical validation of an antiviral's efficacy in hospitalized infants ≤6 months, and demonstrating long-term benefits in reducing recurrent wheezing and asthma.
Study Design
This multicenter, randomized, double-blind, placebo-controlled Phase III trial was conducted at 30 sites in 28 hospitals across China. The trial included two parts:
- Part 1 assessed safety and pharmacokinetics
- Part 2 evaluated clinical efficacy and antiviral effects
Infants were randomized in a 2:1 ratio to receive ziresovir or placebo for five days, with a 24-month follow-up. The latest publication focuses on infants aged six months or younger.
Key Findings
1. Significant Efficacy
- Improved Bronchiolitis Symptoms: By Day 3, ziresovir-treated infants had a 3.5-point reduction in Wang Bronchiolitis Clinical Score (WBCS), compared to 2.2 points in the placebo group—a 54.5% difference (p<0.001). Improvements in respiratory rate, wheezing, and retractions were also statistically significant (p<0.05).
- Rapid Viral Load Reduction: By Day 5, viral load decreased by 2.51 logâ‚â‚€ copies/mL in the treatment group, versus 1.87 logâ‚â‚€ in the placebo group (p=0.024), confirming ziresovir's antiviral activity.
- Faster Symptom Relief: Time to wheezing resolution (HR=1.53, p=0.021) and retraction relief (HR=1.49, p=0.018) were shorter in the treatment group. Hospital stay and oxygen use showed a reduction trend, though not statistically significant.
2. Long-Term Safety and Respiratory Health Benefits
- Favorable Safety Profile: Treatment-emergent adverse events (TEAEs) occurred in 18% of the treatment group vs. 11% in placebo. No drug-related severe adverse events or deaths were reported.
- Reduced Risk of Recurrent Wheezing and Asthma:
- Wheezing incidence was 3.6 times lower in the treatment group (0.18% vs. 0.65%, p=0.0048).
- Wheezing episodes were reduced by 2.6 times (1.2 vs. 3.1 episodes).
- Asthma rates were also lower (3% vs. 5%).
These long-term benefits suggest early antiviral intervention may reduce the risk of chronic respiratory conditions.
A New Era in RSV Treatment
Unlike existing RSV treatments focused solely on symptom relief, ziresovir is the first RSV-targeted antiviral therapy with demonstrated clinical efficacy in infants under six months—those most at risk of severe complications. These findings introduce a new therapeutic paradigm for RSV treatment and prevention of long-term sequelae.
The results were presented by Dr. Jim Wu, CEO of ArkBio, at the 13th International RSV Symposium in Brazil, receiving recognition from the global RSV research community.
Prof. Xin Ni, principal investigator of the Airflo study and professor at Beijing Children's Hospital, Capital Medical University, commented:
"This pivotal Phase III trial provides the first solid evidence of an effective antiviral treatment for RSV in high-risk infants. Following our initial publication in The New England Journal of Medicine, this deeper analysis in infants under six months published in The Lancet Child & Adolescent Health further validates ziresovir's safety, efficacy, and long-term benefit. We are proud of our team's commitment and look forward to bringing this drug to patients in China and worldwide."
For public readers, the article can be accessed at the following link:
https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(25)00067-7/fulltext
About Ziresovir
Ziresovir is a first-in-class, oral small-molecule inhibitor targeting the RSV fusion (F) protein. It prevents viral entry and cell-to-cell transmission by blocking syncytia formation, a hallmark of RSV infection. It is the first oral RSV antiviral to successfully complete a pivotal Phase III trial with positive results and has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of China.
About ArkBio
ArkBio is a global biotech company focused on developing innovative therapies for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house research and collaborations. Key assets include ziresovir, the first direct-acting RSV antiviral with positive pivotal phase III results globally, and AK0901, an FDA-approved pediatric ADHD therapy with commercialization rights in Greater China.
ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology, Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture investment institutions.
For more information about the company, please visit our website: www.arkbiosciences.com
Investor Inquiries: IR@arkbiosciences.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
The Lancet Child & Adolescent Health Publishes Phase III Trial and 24-Month Follow-Up Results of Ziresovir for RSV in Infants Under 6 Months
Thoughtful engineering and refined design come together as Tineco presents its latest smart floor care solutions in immersive, modern living spaces
SEATTLE, Jan. 2, 2026 /PRNewswire/ -- Tineco, a global leader in intelligent home appliances, is returning to CES 2026 to showcase a new lineup of floor care solutions engineered for modern living. Over the years, Tineco has built a global community of more than 23 million users and been recognized as the world's No. 1 household wet & dry vacuum cleaner brand. Its latest collection brings together enhanced performance, refined design, and advanced technology to elevate cleaning experience.
This year at CES, Tineco moves beyond the traditional booth format to create a fully immersive, visually rich space designed to reflect how people live and interact with their homes every day. In this immersive environment, Tineco will introduce multiple experiential zones, each crafted around unique product identities and contemporary living concepts. Across a series of distinct zones, visitors will discover how Tineco integrates into the rhythms of everyday life through the following floor washers:
The Innovation Lab
FLOOR ONE S9 Scientist – In a futuristic, cyberpunk-inspired environment illuminated with LED accents and bold lighting, the S9 Scientist highlights Tineco's technical expertise, featuring intelligent mess detection with Tineco's iLoop™ Smart Sensor and a high-temperature deep cleaning for precision removal of tough stains.
The Creative Studio
FLOOR ONE Station S9 Artist — Designed for refined, design-forward living spaces, the Station S9 Artist blends elevated aesthetics with advanced care performance. It delivers a streak-free, barefoot-ready finish with its StreakFree Scraper, while HydroBurst™ technology uses a high-pressure angled water jet to tackle heavy and dried-on stains. Paired with a Smart Refresh Station that automatically replenishes hot water and a FlashDry™ self-cleaning system with steam, the Station S9 Artist ensures powerful, quiet, and effortless maintenance for modern homes.
The Urban Retreat
FLOOR ONE i7 Fold – Designed for compact, upscale urban homes and tailored to fast-paced, space-conscious lifestyles. This floor washer will make its debut at CES this year. It weighs just under 8 lbs. and features a slim, foldable design for easy storage and a 180° foldable base engineered to reach effortlessly beneath low furniture.
The Flagship Residence
FLOOR ONE S9 Master – Setting the standard for modern luxury living, the S9 Master serves as the flagship of the Master series and represents Tineco's highest level of performance, including a purposeful design, a 180° lay-flat profile, wide-angle DustReveal™ lighting, anti-tangle brush technology, and a responsive color-shifting display for real-time cleaning guidance.
"CES has always been a place to introduce what's next, and this year we're rethinking how we show it," said Mr. Leng, CEO of Tineco. "Through our Modern Living concept, we're moving beyond a traditional booth to create design-led environments that bring thoughtful engineering and refined design to life. Introducing the FLOOR ONE Master Series and FLOOR ONE i7 Fold in this setting reflects our commitment to delivering dependable performance and intentional design for modern households."
At CES, attendees can also explore the brand's broader lineup, including the PURE ONE A90S and S70 stick vacuums, and the award-winning CARPET ONE Cruiser (TIME Best Inventions of 2025 winner).
Visit Tineco at the Venetian Expo, Bellini Boardroom, Spaces 2103 & 2104, on January 6–9, 2026, for a home-inspired showcase designed for hands-on demonstrations and in-depth conversations.
About Tineco
Tineco ("tin-co") was founded in 1998 with its first product launch as a vacuum cleaner and, in 2019, pioneered the first-ever smart vacuum. Today, the brand has evolved into a global leader in intelligent appliances spanning floor care, kitchen, and personal care categories. With a growing user base of over 23 million households and availability in approximately 30 countries worldwide, Tineco remains committed to its brand vision of making life easier through smart technology and continuous innovation. For more information, visit au.tineco.com.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Tineco Debuts Modern Living Concept and Latest Smart Cleaning Lineup at CES 2026
