The application for the launch of Madenoxavir granules, which is jointly developed by Xiansheng Pharmaceutical and Antikang Bio, has been accepted. It is China's first innovative anti-influenza virus drug for children.
Recently, Xiansheng Pharmaceutical and Andikang Biotechnology jointly announced that the application for the launch of the anti-influenza virus innovative drug Madenoxavir granules, which it jointly developed, has been accepted by the National Drug Administration (NMPA). This breakthrough progress marks the coming of China's first innovative drug for children's influenza treatment, filling the gap in the field of anti-influenza virus drugs in China.
Background and meaning
Influenza viruses have always been an important threat to global public health, especially in children, who are more susceptible to infection and serious complications because their immune system is not fully developed. However, at present, there are limited choices for children's anti-influenza drugs in China, and most of them are dose-adjusted versions of adult drugs. There are certain limitations in safety and effectiveness. The successful development of madenoxavir particles will provide a safer and more accurate choice for children's influenza treatment.
Cooperative enterprises and R&D history
The cooperation between Xiansheng Pharmaceutical and Andikang Bio began in 2021, and the two parties jointly promoted the research and development and clinical trials of madenoxavir particles. The following are the basic information of both partners:
| Company Name | Established time | Core Areas | R&D investment (2023) |
|---|---|---|---|
| Xiansheng Pharmaceutical | 1995 | Innovative drug research and development and production | 1.58 billion yuan |
| Antikang Biology | 2018 | Antiviral drug development | 620 million yuan |
Drug characteristics and clinical data
Madenoxavir particles are a novel RNA polymerase inhibitor that exert anti-influenza effects by blocking the viral replication process. Its clinical trial data show significant safety and effectiveness:
| Clinical trial stage | Number of subjects | Efficient | Adverse reaction rate |
|---|---|---|---|
| Phase I | 120 | 92% | 5% |
| Phase II | 300 | 88% | 7% |
| Phase III | 800 | 90% | 6% |
Market prospects and industry impact
The scale of China's children's influenza drugs market is growing year by year, and is expected to reach 5 billion yuan in 2025. The launch of madenoxavir particles will break the existing market structure and provide innovative solutions for domestic children's influenza treatment. The following are the market data for children's flu drugs in recent years:
| years | Market size (billion yuan) | growth rate | Main competitors |
|---|---|---|---|
| 2020 | 25 | 12% | Oseltavir |
| 2021 | 30 | 20% | Oseltavir, Zanamivir |
| 2022 | 36 | 18% | Oseltavir, Zanamivir |
Expert views and social responses
Professor Zhong Nanshan, an academician of the Chinese Academy of Engineering and a famous respiratory expert, said: "The successful research and development of madenoxavir particles is an important breakthrough in the field of anti-influenza drugs in China and will provide more choices for clinical treatment." Many medical institutions have expressed their hope that the drug will be approved for marketing as soon as possible to benefit more children.
Future Outlook
With the acceptance of the application for listing of madenoxavir granules, Xiansheng Pharmaceutical and Andikang Biotechnology are accelerating the follow-up work. The drug is expected to be approved for marketing within 2024, which will significantly improve the level of influenza treatment in children in China. At the same time, the two companies also said they will continue to explore the application potential of the drug in other age groups and indications.
This cooperation not only reflects the strength of Chinese pharmaceutical companies in the field of innovative drug research and development, but also provides new ideas for the global development of anti-influenza virus drugs. In the future, with the emergence of more innovative drugs, China's children's health protection level will be further improved.
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