Author:Qingfeng Pharmaceutical Group
Posted Time:2025-03-27 00:13
On March 27, 2025, Kvvit Pharmaceuticals, a subsidiary of Qingfeng Pharmaceutical Group, received approval to market Yisuda® Suraxavir Marboxil Tablets, an innovative Category 1 drug indicated for the treatment of otherwise healthy adults and adolescents aged 12 and above with uncomplicated influenza A and B infections. In the context of ongoing global influenza virus mutations and the growing challenge of drug resistance faced by traditional antivirals, the emergence of Yisuda® Suraxavir Marboxil Tablets represent a new source of hope, and a breakthrough in influenza prevention and treatment.
Mechanism of Action
Suraxavir Marboxil Tablets is China’s first and the world’s second antiviral drug targeting the polymerase acidic (PA) protein of the influenza virus. It precisely attacks the core driver of viral replication, blocking virus reproduction. A single dose taken at any point during the course of the illness rapidly clears the virus and quickly relieves flu symptoms.
Clinical Advantages
All clinical registration data for Suraxavir Marboxil Tablets are taken from Chinese patients, providing robust evidence based on the Chinese population. Led by Professor Cao Binteam from the China-Japan Friendship Hospital, the Phase III clinical trial was a multi-center, randomized double-blind, placebo-controlled study. The findings were published on January 7, 2025, in the prestigious global medical journal, Nature Medicine.
In the Phase III trial, 591 patients were enrolled, consisting of 80% adults and 20% children and adolescents, randomized in a 2:1 ratio to receive either Suraxavir Marboxil or a placebo. The research results showed:
Rapid Viral Clearance Compared with the placebo, Suraxavir Marboxil significantly accelerated the reduction of viral load from baseline on Day 1 after administration. It rapidly cleared the virus within 24 hours, achieving the treatment goal of “single-dose therapy with virus clearance and fever relief within one day.”
Rapid Relief of Influenza Symptoms The median time to symptom alleviation was shortened by 21 hours compared with the placebo. Fever resolution time was reduced by 8.6 hours compared to the placebo group. The incidence of adverse events was comparable to the placebo, and were mostly mild to moderate, with no reports of serious adverse events, demonstrating the drug’s safety and efficacy.
Broad-Spectrum Antiviral Activity Suraxavir Marboxil shows broad-spectrum antiviral efficacy against both influenza A and B viruses, covering a wider range of viral subtypes.
Excellent Tolerability Suraxavir Marboxil demonstrates superior tolerability compared to international competitors. Only a very small percentage of patients developed resistance mutations (0.7% for H1N1 subtype and 0.9% for H3N2 subtype), far lower than the 9.7% observed in similar internationally available drugs.
Supply Assurance
Qingfeng Pharmaceutical boasts a modern industrial biopharmaceutical base that covers active pharmaceutical ingredient (API) production, formulation manufacturing, and intelligent warehousing. Total production capacity exceeds 4.5 billion tablets per year, ensuring stable drug supply during seasonal influenza outbreaks and peak incidence periods.
The successful approval of Yisuda® Suraxavir Marboxil Tables Tablets represents over a decade of dedicated research efforts by scientists, and reflects Qingfeng Pharmaceutical’s persistent work in achieving innovative breakthroughs. In addition, clinical research plans are underway to expand the indications of Suraxavir Marboxil for influenza prevention and high-risk populations. For young children who have difficulty swallowing tablets, Qingfeng Pharmaceutical is actively developing new formulations to meet their needs.
Looking ahead, Qingfeng Pharmaceutical will continue to focus on innovative drug development, delivering more safe, effective, and convenient treatment options to patients throughout the world, and contributing more “China solutions” to global health.
