Riding the Momentum! Successful Protocol Discussion Meeting Held for Onradivir Granules Phase III Trial in Pediatric Influenza A
Following the recent approval of Onradivir tablets (brand name: ANRUIWEI®) by China’s National Medical Products Administration (NMPA) on May 22, 2025, and the positive topline results from the Phase II trial of Onradivir granules in children and adolescents aged 2–17 with uncomplicated influenza A, Guangdong Raynovent Biotech Co., Ltd. (“Raynovent”) convened a hybrid (in-person and virtual) protocol discussion meeting for the upcoming Phase III clinical trial of Onradivir granules in children aged 2–11. The meeting was successfully held in Beijing on the same historic day.
The Phase II/III clinical program is led by Professor Bao-Ping Xu, Principal Investigator (Leading PI) from Beijing Children’s Hospital, Capital Medical University, who chaired the expert panel to review and finalize the Phase III study protocol. The discussion concluded with strong consensus and marked a critical step toward advancing this novel pediatric antiviral therapy.
Opening Remarks by the Lead Investigator
Professor Xu opened the meeting by congratulating Raynovent on the NMPA approval of Onradivir tablets and emphasized the significance of initiating the pediatric Phase III trial. She expressed gratitude to all experts for their participation and paid tribute to the investigators involved in the successful Phase II study. She underscored the goal of the meeting: to integrate scientific insights from clinical, statistical, and clinical pharmacology experts to refine key elements of the Phase III protocol and reach alignment.
Professor Peng Guo, Executive Director of the Clinical Research Center at Beijing Children’s Hospital, thanked Raynovent for entrusting the hospital as the lead site once again for the Phase III trial. He stressed the importance of rigorous and scientifically sound protocol design to ensure high-quality execution of the upcoming study.
In-Depth Protocol Discussion
Under Professor Xu’s leadership, participants reviewed comprehensive background data—including Onradivir’s preclinical profile, adult Phase II/III efficacy and safety results, pediatric Phase II findings in ages 2–17, and quantitative clinical pharmacology analyses—before engaging in detailed discussions on core aspects of the Phase III design:
Inclusion/exclusion criteria
Study design and control selection
Sample size justification
Dose regimen and administration
Trial procedures and monitoring
Primary and secondary endpoints, including symptom resolution, fever clearance, and virological outcomes
After thorough deliberation, the expert panel reached full consensus on the final protocol framework.
In her closing remarks, Professor Xu highlighted the urgent unmet need in pediatric influenza treatment, particularly amid rising antiviral resistance. She noted that Phase II data demonstrated Onradivir granules’ favorable safety and robust efficacy—showing symptom improvement, faster fever resolution, and accelerated viral clearance comparable to or numerically better than adult results. “These promising findings strongly support advancing to Phase III,” she stated, expressing confidence that, with multidisciplinary collaboration, the trial will be efficiently launched and completed, delivering a much-needed new therapeutic option for Chinese children.
Sponsor’s Acknowledgement
Mr. Haijun Li, Senior Vice President of Raynovent, extended heartfelt thanks to Professor Xu and all experts for their scientific rigor and valuable input. He affirmed Raynovent’s full commitment to coordinating resources, promptly finalizing the protocol, and maintaining close communication with the Center for Drug Evaluation (CDE). “We look forward to completing this pivotal study under Professor Xu’s leadership and bringing this innovative therapy to market as soon as possible to protect children’s health,” he said.
Distinguished Attendees
The meeting brought together leading experts from across China, including:
Beijing Children’s Hospital: Professors Jun Liu, Ju Yin, Liwei Gao, and Xiaohui Liu
Chengdu Women’s and Children’s Central Hospital: Professor Yulei He
The First Affiliated Hospital of Guangzhou Medical University: Professor Zijing Liang
Wuhan Children’s Hospital, Tongji Medical College, Huazhong University of Science and Technology: Professor Xiaoxia Lu
Sanmenxia Central Hospital