Seloxavir Marboxil Tablets Approved: The Quality Control System Behind "Single-Dose Therapy"
Time:2025-07-30
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On July 18, the domestic self-developed anti-influenza oral drug Seloxavir Marboxil Tablets has been officially approved by China‘s National Medical Products Administration (NMPA) for the treatment of uncomplicated influenza in adults.
Seloxavir Marboxil Tablets, China‘s first independently developed novel inhibitor targeting the PA subunit of influenza virus RNA polymerase with global intellectual property rights, exerts antiviral effects by specifically inhibiting viral mRNA transcription, demonstrating sustained antiviral activity.
Mechanism and Clinical Value
As a new-generation endonuclease inhibitor targeting polymerase acidic protein (PA), Seloxavir Marboxil achieves "source eradication" of the virus by blocking viral mRNA transcription. This enables a "single oral dose, full-course efficacy" regimen. Clinical studies confirm its persistent efficacy, significant reduction in treatment duration, low adverse reaction rate , and favorable safety profile, providing an optimal therapeutic option for influenza patients.
Quality Control: The Cornerstone of Safety
During drug development, impurity control is pivotal to ensuring safety. Substances potentially generated during synthesis—such as genotoxic impurities (e.g., nitrosamines)—require stringent and precise control. Comprehensive impurity profiling serves as the "passport" for drug registration evaluation, with professional impurity reference standards providing essential support.
SZEB specializes in integrated solutions for pharmaceutical impurity references, offering comprehensive services to pharmaceutical enterprises and research institutions. For detailed impurity information, visit: http://www.ex-biotech.com.
（Source of information section:：https://news.yaozh.com/）
（Source of information section:：https://news.yaozh.com/）
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