Sebaloxavir Marboxil Tablets Approved by NMPA—Opening a New Era of “Single-Dose Long-Lasting Protection” Against Influenza

Nanjing Zenshine Pharmaceutical Co., Ltd. has announced that its independently developed antiviral drug, Sebaloxavir Marboxil tablets, has officially been approved for marketing by China’s National Medical Products Administration (NMPA).

This approval marks a major milestone in China’s fight against influenza and represents a new generation of broad-spectrum antiviral therapy characterized by “single-dose long-lasting protection.”

A New Generation of Broad-Spectrum Antiviral Innovation

✨ Sebaloxavir Marboxil (formerly known as Maseloxavir, code ZX-7101A) is a novel polymerase acidic protein (PA) endonuclease inhibitor independently developed by Zenshine Pharma.

🎯 By targeting the early replication stage of influenza virus RNA, it effectively blocks viral transcription and replication.

🔬 Preclinical and clinical studies have shown potent antiviral activity against influenza A, influenza B, and highly pathogenic avian influenza viruses, demonstrating broad-spectrum efficacy beyond traditional neuraminidase inhibitors.

Robust Clinical Evidence: Phase II/III Trials Supporting NMPA Approval

The NMPA’s approval of Sebaloxavir Marboxil tablets is supported by a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical study (CTR20221729).

👉 The trial adopted a seamless adaptive design, with a Phase II dose-finding study (n=177) and a Phase III confirmatory study (n=723) to comprehensively assess efficacy and safety.

Phase II: Establishing Efficacy and Optimal Dose

✅ Results demonstrated that baloxavir marboxil significantly shortened the time to alleviation of all influenza symptoms.

The median symptom relief time in the 40 mg and 80 mg dose groups was 34.7 hours and 45.8 hours, respectively, compared with 63.6 hours in the placebo group, confirming strong dose-dependent efficacy.

Phase III: Confirming Superior Clinical Benefit

In the Phase III study, the median time to symptom alleviation was 48.4 hours (40 mg) and 39.4 hours (80 mg) versus 62.9 hours in the placebo group.

Secondary endpoints—including time to viral RNA negativity, viral titer clearance, and fever resolution—also showed statistically significant improvement over placebo.

Three Core Advantages: “Single-Dose, Fast-Acting, Safe for All”

🌟 Sebaloxavir Marboxil tablets embody three distinct advantages—single-dose long-lasting protection, rapid onset, and high safety—offering both physicians and patients a convenient and effective new treatment choice.

Single-Dose Long-Lasting Protection

Unlike traditional antivirals requiring multiple doses, Sebaloxavir Marboxil tablets achieve full therapeutic coverage with a single oral administration.

Phase III results showed that the treatment shortened symptom duration by 15–23 hours compared with placebo, enabling a complete treatment course with just one dose.

✨This simplifies patient compliance, reduces missed doses, and provides long-lasting protection throughout the course of infection.

Fast-Acting Relief: Fever Reduction Within 1 Day

Clinical data demonstrated that fever relief occurred within 23 hours and complete symptom resolution within 39.4 hours of dosing.

Viral titer clearance occurred in a median of 22.7 hours, with viral RNA turning negative significantly faster than placebo.

This rapid onset translates to faster recovery, fewer days lost to illness, and improved quality of life for patients—especially valuable during seasonal influenza outbreaks.

Safe, Reliable, and Broadly Applicable

👌 Sebaloxavir Marboxil tablets showed an excellent safety profile, with overall adverse event rates of 41.8% (40 mg) and 44.2% (80 mg), comparable to 53.8% in the placebo group.

Most adverse events were mild or moderate, and no serious drug-related events were observed.

Importantly, the drug is not metabolized through CYP450 enzymes, minimizing drug-drug interaction (DDI) risks—making it suitable for patients with multiple comorbidities or chronic medication use.

✅ In resistance analysis, only a 1.8% mutation rate was observed, far lower than that of existing influenza antivirals, indicating low resistance potential and long-term clinical value.

Redefining Influenza Treatment: China’s Innovation on the Global Stage

💪 The approval of Sebaloxavir Marboxil tablets not only fills a domestic gap in PA endonuclease inhibitor development but also showcases China’s growing strength in antiviral innovation.

💊 Its single-dose convenience, long-lasting protection, and rapid efficacy offer an efficient and patient-friendly influenza treatment solution.

Conclusion: Entering a New Era of “Single-Dose Long-Lasting Protection”

With the market approval of Sebaloxavir Marboxil tablets, China officially enters a new era of “Single-Dose Long-Lasting Protection.”

🌍 With its single-dose regimen, rapid efficacy, and excellent safety, baloxavir marboxil is poised to redefine influenza treatment standards in China and beyond.

With the flu season becoming a regular occurrence, there is a growing need for treatments that are efficient, safe, and easy to use.

Hong Kong DengYue Medicine is leveraging its strong distribution network and professional promotion system to improve the accessibility of Sebaloxavir Marboxil Tablets across China. 🔻

We aim to ensure that more doctors and patients can quickly and conveniently benefit from this innovative flu treatment.