Domestic single-dose flu drug approved

China's top drug regulator announced on Friday that it has approved a domestically developed flu drug requiring only a single dose throughout the entire treatment course, offering a new solution for an illness that infects five to 10 percent of adults globally each year.

The first-in-class innovative drug has been authorized to treat adult patients with uncomplicated influenza A and B, excluding those at high risk of severe flu-related complications, according to a statement from the National Medical Products Administration.

The drug, named ZX-7101A in clinical trials, was developed by Zenshine, a pharmaceutical company in Nanjing, Jiangsu province.

Results from a late-stage clinical trial, led by research teams at the National Medical Center for Infectious Diseases at Fudan University's Huashan Hospital in Shanghai, were published in the international journal Clinical Microbiology and Infection in January. The study found that ZX-7101A effectively treated influenza with a single dose of either 40 milligrams or 80 mg and caused no major adverse reaction.

Participants who received a single dose experienced quicker symptom relief and tested negative for the virus faster than those given a placebo. Fever symptoms also subsided significantly within less than 24 hours, according to the study.

In a statement released on Friday, the company said the drug also demonstrated a low incidence of adverse reactions, with gastrointestinal side effects occurring in only 0.3 percent.

"This significantly reduces the clinical challenge of frequent nausea, vomiting, and diarrhea associated with traditional anti-influenza drugs," the statement said.

Additionally, the drug's unique metabolic mechanism lowers the risk of drug-drug interactions, meaning it won't interfere with other medications taken simultaneously.

"It provides a safer therapeutic option for patients with multiple conditions requiring medications," the company said.

Yang Jinfu, cofounder and chairman of the company, said that they will accelerate research into the drug's potential for treating other age groups and work to expand its approved age range.

The first and most widely used single-dose antiviral flu pill is baloxavir marboxil, marketed as Xofluza and developed by the global pharmaceutical giant Roche. It was first approved in China in April 2021.

With this latest approval, China now has two domestically developed medications that could potentially rival Roche's product.

The other domestic single-dose flu treatment, suraxavir marboxil, was developed by a Jiangxi-based drugmaker and approved by the National Medical Products Administration in March.