Top-Line Analysis Data Results Obtained for Two Phase III Clinical Trials of Onradivir Granules (Pediatric) and Onradivir Tablets (Adolescent)!
Raynovent's independently developed Class 1 innovative drug—Phase III clinical trial of Onradivir Granules for treating simple influenza A in patients aged 2-11 years (hereinafter referred to as "Onradivir Granules Pediatric Phase III Clinical Trial") and Phase III clinical trial of Onradivir Tablets for treating simple influenza A in patients aged 12-17 years (hereinafter referred to as "Onradivir Tablets Adolescent Phase III Clinical Trial")—recently obtained top-line analysis data. Preliminary results indicate that Onradivir Granules demonstrated positive efficacy and favorable safety in participants aged 2-11 years with simple influenza A, while Onradivir Tablets showed positive efficacy and favorable safety in participants aged 12-17 years with simple influenza A. The trial results are ideal and met the expected objectives.
Part 1: Phase III Clinical Trial Status of Onradivir Project
To facilitate medication for children, adolescents, and influenza patients with swallowing difficulties, the company organized and implemented the Onradivir Granules Pediatric Phase III Clinical Trial and the Onradivir Tablets Adolescent Phase III Clinical Trial. The Onradivir Granules Pediatric Phase III Clinical Trial adopted oseltamivir phosphate dry syrup (Roche Pharmaceuticals, brand name: Tamiflu®) as the control and enrolled a total of 120 participants. The Onradivir Tablets Adolescent Phase III Clinical Trial adopted placebo as the control and enrolled a total of 157 participants.
01 Efficacy Results
The Onradivir Granules Pediatric Phase III Clinical Trial used the Canadian Acute Respiratory Illness and Flu Scale (CARIFS, a comprehensive scale applicable for evaluating cold efficacy in children) to comprehensively assess participant efficacy. Results showed that for the primary efficacy endpoint—median time to alleviation of influenza symptoms—the Onradivir Granules group and the oseltamivir group were 82.5 hours and 107.1 hours, respectively, with the Onradivir Granules group shortening the time by 23% compared to the oseltamivir group. For median time to fever alleviation, the Onradivir Granules group and the oseltamivir group were 21.0 hours and 28.9 hours, respectively, with the Onradivir Granules group shortening the time by 27% compared to the oseltamivir group. In virological indicators, the Onradivir Granules group showed significantly superior viral load reduction at 24 hours post-dosing compared to the oseltamivir group, with significantly shorter detectable virus time. The number of influenza-related complications in the Onradivir Granules group and the oseltamivir group were 0 cases (0%) and 2 cases (5.3%), respectively.
Literature data shows that baloxavir conducted a Phase III clinical trial (miniSTONE-2) in children aged 1-12 years with oseltamivir dry syrup as control. The median time to alleviation of influenza symptoms measured by the CARIFS scale was 138.1 hours for the baloxavir group, shortening by only 8% compared to the oseltamivir group (150.0 hours). The median time to fever alleviation was 41.2 hours for the baloxavir group, shortening by only 12% compared to the oseltamivir group (46.8 hours). The number of influenza-related complications in the baloxavir group and the oseltamivir group were 6 cases (7.4%) and 3 cases (7.0%), respectively.
The Onradivir Tablets Adolescent Phase III Clinical Trial used seven-item influenza symptom alleviation time to comprehensively assess participant efficacy. Results showed: for the primary endpoint—median time to alleviation of seven influenza symptoms—the Onradivir Tablets group and the placebo group were 51.4 hours and 80.4 hours, respectively, with the Onradivir Tablets group significantly shortening the time by 36% compared to the placebo group. For the secondary endpoint—median time to fever alleviation—the Onradivir Tablets group and the placebo group were 22.7 hours and 32.8 hours, respectively, with the Onradivir Tablets group significantly shortening the time by 31% compared to the placebo group. In virological indicators, the Onradivir Tablets group showed significantly superior viral load reduction at 24 hours post-dosing compared to the placebo group, significantly shortening the time to viral clearance, reproducing the superior results observed in the adult Phase III clinical trial. The number of influenza-related complications in the Onradivir Tablets group and the placebo group were 0 cases (0%) and 1 case (2.0%), respectively.
The already approved Onradivir Tablets (brand name: Anruiwei®) for treating adult simple influenza A participants showed a median time to alleviation of seven influenza symptoms significantly shortened by 39% compared to the placebo group, with viral load reduced by 10-fold one day after dosing. Onradivir achieved positive efficacy results in both clinical symptoms/signs and virological aspects in pediatric and adolescent influenza A participants, highly consistent with the adult population.
02 Safety Results
No serious adverse events occurred in this clinical trial. Adverse reactions observed after Onradivir administration were mainly gastrointestinal symptoms. The vast majority of participants' adverse reactions completely resolved without intervention, indicating that Onradivir has good safety and tolerability in children and adolescents.
Part 2: Diligent Progress Toward Market Approval
The top-line analysis data results from these two Phase III clinical trials of Onradivir represent an important milestone in the project's development process and lay a solid clinical foundation for subsequent drug marketing applications. As the world's first innovative anti-influenza drug targeting the PB2 subunit of influenza A virus RNA polymerase, Onradivir has already demonstrated advantages of rapid action, potent efficacy, and low resistance in adult influenza A treatment. These two Phase III clinical studies further focus on the special population of pediatric and adolescent influenza patients, filling the demand gap in this treatment area.
Next, Raynovent will accelerate the preparation of marketing application matters, efficiently complete the entire process of document submission and review follow-up, striving to have this innovative drug approved and launched as soon as possible. The company has always adhered to the "patient-centered" philosophy, deeply cultivating the field of anti-influenza innovative drug research and development. This advancement of Onradivir's expanded indication approval aims to provide a safer and more convenient new treatment option for the vast population of pediatric and adolescent influenza patients, safeguarding public health and life.