.jpg)
Yisuda®Suraxavir Marboxil Tablets
Suraxavir Marboxil Tablets (Brand Name: Yisuda®) is a new chemical entity independently developed by Kvvit Pharmaceutical. It is indicated for the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 years and above. Approved for launch in March 2025, it is the world’s second and China’s first PA inhibitor for influenza treatment. It rapidly reduces influenza viral load by blocking viral replication at an early stage. Suraxavir requires only a single dose for the full treatment course, helping alleviate influenza symptoms while lowering the risk of secondary infections.
R&D Milestones
2025
In July 2025, the NDA for the dry suspension formulation was submitted for market approval.
2025
In March 2025, Suraxavir Marboxil Tablets was approved for launch.
2023
In December 2023, the INN confirmation letter was received from the World Health Organization, granting the product its global generic name—Suraxavir Marboxil.
2023
In April 2023, Phase III clinical trials were completed, fully verifying the efficacy and safety of the product and achieving a major milestone for the project.
2020
In June 2020, clinical trial approval was granted, marking the entry into Phase I clinical research.
2018
In December 2018, the compound patent was filed, marking the official launch of the project.
R&D Story
Clinical Advantages
All registration clinical data of Suraxavir Marboxil Tablets were sourced from Chinese patients, providing solid clinical evidence for the Chinese population. The Phase III clinical trial was led by the research team of Professor Cao Bin from China-Japan Friendship Hospital. Adopting a multi-center, stratified randomized, double-blind, and parallel placebo-controlled design, the research findings were published in the top global medical journal Nature Medicine on January 7, 2025.
Research Results
01
Rapid Viral Clearance
Compared with the placebo group, Suraxavir Marboxil showed a faster decline in viral load from baseline on Day 1 after administration. It demonstrated significant viral load reduction within 24 hours, achieving the efficacy of a single-dose treatment course, with viral load reduction and fever relief within one day.
02
Fast Relief of Influenza Symptoms
The median time to symptom relief was significantly shortened by 21 hours compared to the placebo group; the time to fever relief was significantly reduced by 8.6 hours compared to the placebo group. The incidence of adverse events was comparable to the placebo group, most of which were mild to moderate. No serious adverse events were reported, demonstrating a favorable safety and efficacy profile.
03
Broad‑Spectrum Antiviral Activity
Suraxavir Marboxil demonstrates broad‑spectrum antiviral activity against influenza A and B viruses, covering a wide range of viral subtypes.
04
Excellent Tolerability
It shows favorable tolerability compared with existing therapies. Drug resistance mutations occurred in only a small proportion of patients (0.7% for H1N1 subtype and 0.9% for H3N2 subtype), significantly lower than global benchmark therapies.
News Highlights
