Gathering Momentum and Setting Sail! Successful Protocol Discussion Meeting Held for Onradivir Tablets Phase III Trial in Adolescents with Influenza A

Time:2026.05.06Views:61Author:众生睿创

Following the official approval of Onradivir tablets (brand name: 安睿威®) by China's National Medical Products Administration (NMPA) and the successful conclusion of the "Protocol Discussion Meeting for Onradivir Granules Phase III Trial in Pediatric Influenza," Guangdong Raynovent Biotech Co., Ltd. ("Raynovent") convened the "Protocol Discussion Meeting for Onradivir Tablets Phase III Clinical Study in Adolescents Aged 12–17 with Uncomplicated Influenza A" on May 24, 2025. The hybrid (in-person and virtual) meeting was successfully held in Guangzhou, the City of Rams.

Professor Jiemin Qu, Leading Principal Investigator (Leading PI) of the adolescent influenza Phase III clinical program from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, chaired the expert panel to review and finalize the Phase III study protocol, achieving full consensus and marking another milestone in expanding Onradivir's therapeutic reach.

01 Welcome Address by the Lead Investigator

Professor Qu delivered the opening remarks, emphasizing that influenza, as a respiratory infectious disease persisting for over a century, remains a significant global public health challenge. He noted that Onradivir tablets have demonstrated remarkable efficacy and favorable safety in adult populations, with its unique mechanism of action conferring low resistance risk. The drug has now officially received NMPA approval for marketing.

"Extending this therapeutic option to adolescents is of great significance for enriching clinical treatment choices for adolescent influenza A," Professor Qu stated. He expressed gratitude to all experts for their participation despite busy schedules and highlighted the meeting's objective: to engage multidisciplinary experts in discussing key issues of the adolescent Phase III trial and reach consensus. The meeting was moderated by Mr. Haijun Li, Senior Vice President of Raynovent.

02 In-Depth Clinical Trial Protocol Discussion

Under Professor Qu's leadership, experts from respiratory medicine, infectious diseases, emergency medicine, statistics, and clinical pharmacology reviewed comprehensive background data—including Onradivir's R&D history, preclinical results, adult Phase II/III findings, pediatric and adolescent Phase II outcomes, and quantitative clinical pharmacology analyses—before engaging in detailed discussions on critical aspects of the adolescent Phase III protocol:

  • Inclusion/exclusion criteria

  • Study design and control selection

  • Sample size determination

  • Dose regimen and administration

  • Trial procedures and monitoring

  • Efficacy endpoints and evaluation criteria

The multidisciplinary panel provided valuable insights and constructive recommendations throughout the deliberation.

In his closing summary, Professor Qu underscored the limited options currently available for influenza antiviral therapy and the serious challenges posed by viral resistance to clinical treatment and patient health. He highlighted that completed clinical studies have demonstrated Onradivir's excellent safety and efficacy profile, with superior outcomes in symptom improvement, fever resolution, viral load reduction, and viral clearance time—providing strong rationale for advancing to adolescent Phase III investigation.

Professor Qu noted that adolescent clinical trial enrollment presents unique challenges and emphasized the importance of coordination and collaboration among all participating parties. "Through today's multidisciplinary and multi-dimensional discussions, experts have reached consensus," he stated. "We look forward to smoothly advancing the Phase III study initiation and execution with the joint efforts and support of all participating institutions, completing the trial with high quality, and expanding Onradivir tablets' indication to adolescents aged 12–17."

03 Sponsor's Acknowledgement

Dr. Xiaoxin Chen, President of Raynovent, extended heartfelt gratitude to Professor Qu and all experts for their enthusiastic support and scientific recommendations. "Raynovent will fully support the conduct of the Phase III clinical trial of Onradivir tablets in adolescents," Dr. Chen affirmed. "We look forward to the successful completion of this trial through collective efforts, further expanding the eligible population, and safeguarding the health of adolescents nationwide."

Distinguished Attendees

The meeting brought together leading experts from across China, including: