Author:Qingfeng Pharmaceutical Group
Posted Time:2025-01-13 00:00
Nature Medicine (Impact Factor: 58.7) is a leading international journal specializing in biochemical and molecular biology-medical research. Indexed by the authoritative SCIE database, the journal focuses on key studies and cutting-edge advancements in the fields of biochemistry, molecular biology, and medicine.
On January 7, 2025, the Phase III clinical trial results for Suraxavir Marboxil Tablets, a Class 1 innovative drug developed by Qingfeng Pharmaceutical, were published in Nature Medicine (Impact Factor: 58.7), a world-renowned journal focused on translational and molecular medicine, indexed by SCIE. As China’s first domestically developed influenza antiviral targeting the polymerase acidic (PA) protein, Suraxavir Marboxil's registration data is entirely derived from Chinese patients, providing robust population-specific information. The product is expected to be approved for market launch in China in the first half of 2025.
Study Design
This Phase III multi-center, randomized, double-blind, placebo-controlled clinical trial was led by Professor Cao Bin’s team at the China-Japan Friendship Hospital. It aimed to evaluate the efficacy and safety of Suraxavir Marboxil in alleviating influenza symptoms and clearing the virus, with a low incidence of resistant mutations.
A total of 591 patients were enrolled, aged 5–65, consisting of 80% adults and 20% children or adolescents. Participants were randomly assigned in a 2:1 ratio to receive either Suraxavir Marboxil or a placebo.
Subjects aged 5 to 65 years with an axillary temperature of 37.3°C or higher and confirmed positive by rapid antigen or nucleic acid testing.
Subjects experienced at least one systemic and one respiratory influenza symptom of moderate or greater severity within 48 hours of symptom onset.
Study Outcomes
The data demonstrated that Suraxavir Marboxil significantly shortened the time to symptom relief and achieved rapid viral clearance within 24 hours. The drug exhibited favorable safety and tolerability profiles, with a low incidence of antiviral resistance.
■ Clinical Efficacy
Compared to the placebo group, the median time to relief from influenza symptoms was shortened by 21 hours, while fever resolution was accelerated by 8.6 hours.
■ Anti-Infection Effectiveness
Suraxavir Marboxil demonstrated a faster reduction in viral load from baseline on the first day after treatment compared to a placebo. The average viral load decrease in the Suraxavir Marboxil group was -2.2 ± 1.3 log₁₀ copies/mL, versus -1.3 ± 1.7 log₁₀ copies/mL in the placebo group.
■ Safety and Low Resistance
No fatal serious adverse events occurred during the study. The incidence of adverse events and adverse reactions in the Suraxavir Marboxil group was comparable to the placebo group. Only three participants developed resistance-associated I38T amino acid substitutions on day 5 of treatment, with mutation rates of 0.7% for H1N1pdm and 0.9% for H3N2 subtypes. No mutations were observed in the influenza B and placebo groups.
A “China Solution” for Influenza Treatment
According to a recent press briefing by the National Center for Disease Control and Prevention, seasonal influenza outbreaks are intensifying in China, with a significant rise in positive influenza virus detection rates. Over 99% of cases are caused by influenza A viruses.
Suraxavir Marboxil Tables are intended for the treatment of uncomplicated influenza A and B infections in adults and children aged 5 years and older. By intervening early in the viral life cycle, the drug directly inhibits the formation of mature viruses, requiring only a single dose during the entire course of treatment. For children, students, the elderly, and working adults, Suraxavir Marboxil significantly shortens the illness period and rapidly alleviates symptoms, minimizing the impact of influenza on daily life and productivity.
With the ongoing spread of influenza, demand for anti-infection medications has surged dramatically, causing shortages and posing challenges to public health authorities and pharmaceutical manufacturers. Qingfeng Pharmaceutical has established a modern industrial biopharmaceutical base which covers raw material sourcing, formulation production, and intelligent warehousing. Production capacity exceeds 4.5 billion tablets per year. With its comprehensive marketing system, Qingfeng is well-positioned to ensure stable drug supply during seasonal influenza peaks and outbreak periods.
Additionally, Qingfeng Pharmaceutical has included influenza prevention and treatment for high-risk populations in the clinical development plan for new formulations of Suraxavir Marboxil Tables. To better serve young children who have difficulty swallowing tablets, the company is also actively developing new dosage forms tailored to their needs.
Original source: https://www.nature.com/articles/s41591-024-03419-3
