The Guangzhou National Laboratory has spearheaded the development of Onradivir tablets, the world's first innovative drug targeting the PB2 subunit of the influenza A virus RNA polymerase, which demonstrates a 40% faster reduction in symptoms in clinical trials compared to placebo.

The drug has been approved for marketing by China's National Medical Products Administration in May.

Significant efficacy

Relevant researchers indicate that Onradivir boasts remarkable advantages of rapid action, strong potency, and low resistance, promising to elevate the overall level of influenza prevention and treatment in China and globally.

Research data reveal that after taking Onradivir, patients experience a rapid decline in viral load. In vitro antiviral activity studies show a nearly 40% reduction in symptom relief time compared to the placebo group (untreated group). In terms of fever reduction, the time is shortened by nearly 39% compared to the placebo group.

Notably, Onradivir exhibits a low rate of resistant mutations, with no suspected resistance cases in Phase II clinical trials and a 1.6% incidence in Phase III. It is also effective against "super flu viruses" resistant to some other marketed anti-influenza drugs.

Furthermore, Onradivir offers "multi-purpose" benefits, being effective against highly pathogenic avian influenza viruses such as H7N9 and H5N6, thus providing a tool for responding to avian-to-human influenza outbreaks.

Providing a Chinese solution for global influenza control

Globally, there are approximately 1 billion influenza cases annually, including 3 to 5 million severe cases and 290,000 to 650,000 deaths. The influenza season during winter and spring imposes a significant public health burden worldwide.

Onradivir, as a new drug targeting the PB2 subunit, employs a "cap-snatching" mechanism (seizing the mRNA cap of host cells), distinct from Baloxavir's "endonuclease cleavage" mechanism (cutting host mRNA). Previous attempts by foreign institutions to develop drugs using this mechanism did not achieve final success in clinical studies.

As the world's first innovative drug targeting the PB2 subunit, Onradivir tablets offer a novel target for drug-resistant viruses, representing a Class 1 innovative drug of international standard from China.

The drug has been granted patent authorizations in multiple countries, including China and the United States. Preclinical basic pharmacological studies, as well as results from Phase II and III clinical trials, have been published in journals such as Drugs, The Lancet Infectious Diseases, and The Lancet Respiratory Medicine.

Zhong Nanshan, Academician of the Chinese Academy of Engineering and Director of the Guangzhou National Laboratory, stated that Onradivir's contribution lies not only in breakthroughs in drug efficacy and safety but also in providing a Chinese solution for global influenza control.

"Now we are very confident that it can be better than other international drugs and even more affordable," said Zhong.

Photo & Video | Pan Jiajun