National Investigator Meeting for Onradivir Granules/Tablets Phase III Clinical Studies in Children and Adolescents with Influenza A Successfully Concluded
October 25, 2025, Xiamen – Guangdong Raynovent Biotech Co., Ltd. ("Raynovent") successfully held two National Investigator Meetings on the same day: the morning session focused on the Phase III clinical study of Onradivir granules for treating influenza A in children aged 2-11, while the afternoon session addressed the Phase III clinical study of Onradivir tablets for treating influenza A in adolescents aged 12-17. Both meetings achieved complete success.
Under the guidance of National Principal Investigators Professor Baoping Xu from Beijing Children's Hospital, Capital Medical University (Leading PI for granules) and Professor Jiemin Qu from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (Leading PI for tablets), over 300 principal investigators (PIs), researchers, and institutional representatives from more than 100 clinical centers across the country gathered in Xiamen in person to collaborate on the high-quality execution of the Phase III clinical studies for Onradivir, China's original innovative anti-influenza drug, pooling wisdom and reaching consensus.
Ms. Yuchong Zhang, actual controller and Deputy Chairwoman of Zhongsheng Pharmaceutical Group, and Dr. Xiaoxin Chen, President of Raynovent, attended and delivered speeches. Mr. Tiejun Cao, Chairman of Stamm Group (clinical CRO partner), provided support. The meetings were moderated by Mr. Haijun Li, Senior Vice President of Raynovent.
01 Opening Ceremony and Welcome Remarks
Dr. Xiaoxin Chen, President of Raynovent, delivered the opening welcome speech, introducing the development journey of Onradivir and expressing gratitude to Academician Nanshan Zhong, the Leading PI for adult Phase II/III clinical studies of Onradivir tablets, and all participating clinical centers.
As the world's first "cap-snatching" inhibitor targeting the influenza virus PB2 protein, Onradivir provides a novel treatment option for influenza with its characteristics of potent efficacy, broad spectrum, rapid action, and low resistance. In May of this year, Onradivir tablets received domestic approval for marketing, and its Phase III research results were published in The Lancet Respiratory Medicine, demonstrating significant advantages in rapidly reducing viral load and shortening disease duration.
Dr. Chen also highlighted the particularities and challenges of clinical trials in children and adolescents with influenza, expressing expectations that under the leadership of Leading PIs Professor Xu Baoping and Professor Qu Jiemin, and with the cooperation and support of all participating units, the Phase III clinical studies of Onradivir in pediatric and adolescent populations will achieve complete success.
Professor Peng Guo and Professor Baoping Xu from Beijing Children's Hospital, Capital Medical University, the lead institution for the Onradivir granules project, delivered welcome remarks respectively.
Professor Guo Peng outlined several requirements for the high-quality conduct of clinical research and expressed hope that this drug would provide a new solution for pediatric influenza treatment.
Professor Xu Baoping expressed gratitude to all center PIs and research representatives for attending the on-site discussions on trial quality control strategies. She noted that Onradivir is a novel mechanism anti-influenza drug and hoped that all centers would complete the Phase III trials during the peak influenza season for children, bringing new hope for pediatric influenza treatment at maximum speed.
Professor Jiemin Qu, Leading PI for Onradivir tablets from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, delivered welcome remarks. Professor Qu emphasized that Onradivir research holds significant clinical importance. During each influenza epidemic cycle, adolescents often become a high-incidence group due to intensive academic schedules, active social interactions, and developing immune systems, making them a key focus for clinical prevention and treatment. He expressed hope that all research centers would collaborate closely to ensure the smooth progress of the study and safeguard the health of our nation's youth.
02 Precise Protocol Interpretation and Experience Sharing
Ms. Yun Peng, Senior Medical Director of Raynovent's Clinical Medicine Department, provided a detailed introduction to previous Onradivir trial results and offered meticulous interpretation of the Phase III clinical study protocols for children and adolescents.
Mr. Zhen Fan, Project Director of Stamm CRO, detailed the project management workflow and subsequent advancement plans. Guest speakers Professor Yuguang Liang from Beijing Children's Hospital, Capital Medical University, shared insights on pediatric influenza clinical trial center processes and quality management essentials. Professor Yulei He from Chengdu Women's and Children's Central Hospital shared management techniques for pediatric influenza clinical trials, focusing on optimizing children's medication experience and compliance. Professor Daojiang Shen from Zhejiang Hospital and Professor Can Jin from Yanbian University Affiliated Hospital exchanged experiences on adolescent influenza clinical trial informed consent techniques and participant retention strategies.
Under the leadership of Professors Xu Baoping and Qu Jiemin respectively, investigators and institutional experts from various centers actively contributed suggestions and engaged in enthusiastic discussions on key topics including clinical study protocol design, risk prevention and control, and clinical trial operational standards. The meetings successfully consolidated expert wisdom and practical experience, enhancing awareness and reaching consensus for the efficient advancement and high-quality execution of Onradivir Phase III clinical trials.
03 PI's Heartfelt Message: Creating China's Excellence Together
The two studies shine like innovative twin stars in the field of pediatric and adolescent influenza treatment. Onradivir tablets, with their characteristics of potent efficacy, broad spectrum, rapid action, and low resistance, are expected to address the challenge of academic disruption in adolescent influenza treatment. Meanwhile, Onradivir granules bring a novel solution for influenza treatment in younger children through optimized drug taste and delivery methods. The simultaneous advancement of both studies not only provides more precise and safer treatment options for pediatric and adolescent populations but also injects new vitality into domestic influenza drug development.
04 Group's Commitment to Innovation: Comprehensive Support and Safeguard
The meetings concluded successfully amid enthusiastic discussions and summaries. Ms. Yuchong Zhang, actual controller and Deputy Chairwoman of Zhongsheng Pharmaceutical Group, delivered closing remarks, expressing profound respect to Leading PIs Professors Xu Baoping and Qu Jiemin, and heartfelt gratitude to all attending experts and partner representatives. She noted that the two Phase III clinical studies launched for Onradivir will further expand coverage to more populations. As the 4th and 5th Phase III clinical studies initiated by Raynovent this year, they not only witness our "accelerated pace" in innovative drug development but also demonstrate our determination to deeply cultivate the respiratory antiviral field.
The company will continue to increase R&D investment, promote the efficient and high-quality completion of the Onradivir series studies, and contribute China's original strength to the field of pediatric and adolescent influenza treatment. In the future, Zhongsheng Pharmaceutical will join hands with clinical researchers, combining scientific rigor with nurturing warmth, to overcome challenges together, create superior influenza treatment solutions for children and adolescents, and contribute to Healthy China!