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 /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:

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

2. Long-Term Safety and Respiratory Health Benefits

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

BANGKOK, April 23, 2025 /PRNewswire/ -- The International Education group at Cambridge University Press & Assessment (Cambridge) today announced primary teacher, Polly Neville from Denla British School Bangkok, as the regional winner of the 2025 Cambridge Dedicated Teacher Awards in Southeast Asia & Pacific. Selected by the judges for her dedication to making sure all her learners feel seen, Polly is the first teacher in Thailand to be recognised as a regional winner in the competition's seven-year history. 

Polly is one of nine regional winners of the global Cambridge competition that celebrates the achievements of teachers around the world. As a regional winner, she will win £500 worth of books for her class, a trophy, take part in a regional awards ceremony and receive publicity for herself and her school during the coming year. She will also appear on a 'Thank you' page at the front of a range of new Cambridge textbooks, available to the public from November 2025.

Originally from the UK, Polly has been a primary school teacher for 16 years and is currently Head of Section for Years 5 and 6 at Denla British School. She is passionate about pastoral care and thrives in her role supporting the wellbeing of all children in the section. Polly was nominated by the parent of one of her students, thanking her for the 'Friday Friends Club' – a social group where students discuss empathy, effective conversation, and feelings.

Polly said, 'The greatest reward in my role is watching students grow in confidence, develop independence and find joy in facing challenges. Through my pastoral care initiatives, I aim to create a space where every child feels seen, heard, and valued. Strong partnerships between school, parents and students are essential to me. I want children and parents to know they have a solid support network here. If I've helped even one child and their family feel more accepted and empowered, then I've fulfilled my purpose.' 

Global winner voting 

The Cambridge Dedicated Teacher Awards gives students, parents and peers the chance to nominate a current primary or secondary teacher for outstanding commitment to their students' education. By going to dedicatedteacher.cambridge.org/vote, the public can now vote for Polly, or another of the nine regional winners to become the overall, global winner of the Cambridge Dedicated Teacher Awards 2025. The deadline to vote is 30 April 2025 and the winner will be announced on 21 May 2025.

The 2025 competition received over 5000 nominations for teachers in 101 different countries around the world. Nominations not only thanked teachers for the hard work they put into teaching, but also for all the extra things they do to ensure their students are happy and healthy.

Rod Smith, Managing Director of International Education said, 'At Cambridge, we are constantly inspired by the stories of teachers who go above and beyond, not for recognition but because they believe in the power of education to change lives. In an industry where AI is making all the headlines, it's uplifting to see the warmth and humanity that this year's winners have brought to their classrooms.

'These awards are a yearly reminder that teachers remain the most vital part of delivering a rounded education. Technology, no matter how sophisticated, cannot replicate the empathy, creativity, social guidance and the sheer inspiration that a great teacher like Polly can provide. I congratulate Polly on her immense accomplishments, which I'm sure will inspire teachers and learners across Thailand.'

To find out more about Cambridge and vote for your favourite teacher in the competition, please visit dedicatedteacher.cambridge.org/vote

-ENDS-

About Cambridge

Cambridge University Press & Assessment is part of the University of Cambridge. Our International Education group works with over 10,000 schools in 160 countries to provide education that shapes knowledge, understanding and skills. Together, we give learners the confidence they need to thrive and make a positive impact in a changing world. We offer a globally trusted and flexible framework for education from age 3 to 19 (the Cambridge Pathway), informed by research, experience, and listening to educators. With internationally recognised qualifications (such as Cambridge IGCSE and International AS & A Level), high-quality resources, comprehensive teaching support and continuing professional development, we help schools prepare every student for the opportunities and challenges ahead. Together, we help Cambridge learners be ready for the world.

Learn more at www.cambridgeinternational.org

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Thailand celebrates first ever regional winner in Cambridge Dedicated Teacher Awards