China's National Medical Products Administration has approved onradivir, a groundbreaking homegrown influenza treatment that represents the world's first anti-influenza drug targeting the PB2 protein of the virus's RNA polymerase. The first-in-class innovative medicine has been authorized for treating adult patients with uncomplicated influenza A, offering a novel therapeutic approach to combat a disease that affects approximately 1 billion people globally each year.
Novel Mechanism of Action
Onradivir distinguishes itself from existing influenza treatments through its unique targeting mechanism. According to Raynovent, the Guangzhou-based company that jointly developed the drug with the First Affiliated Hospital of Guangzhou Medical University and leading respiratory disease research institutions, the medicine targets a protein of the virus's RNA polymerase called PB2. This novel approach represents a significant departure from current treatment paradigms and offers what the company describes as "rapid, potent and low-resistance efficacy."
The drug is administered as a 0.6-gram tablet, with the recommended dosing regimen of three doses daily for five consecutive days.
Superior Clinical Performance
Clinical studies demonstrate that onradivir outperforms established influenza treatments in key efficacy measures. The drug acts faster than the two most commonly used flu treatments currently on the market—oseltamivir and baloxavir marboxil—in both easing symptoms and reducing viral load in patients.
Zhong Nanshan, an academician with the Chinese Academy of Engineering and renowned respiratory expert involved in the drug's development, highlighted the medication's rapid onset of action. "Onradivir can quickly alleviate symptoms and suppress the viral load to a very low level within 24 hours, making it less likely for the virus to transmit," Zhong stated during a recent event, as reported by Nanfang Media Group.
Addressing Resistance Concerns
A critical advantage of onradivir lies in its resistance profile. Zhong emphasized that "the drug also shows a low tendency to develop resistance," addressing a significant concern in influenza treatment where viral resistance can limit therapeutic options.
Li Tongzeng, chief physician at Beijing You'an Hospital who was not involved in the research, explained the clinical significance of this novel mechanism. "Because onradivir targets a different mechanism than the other two drugs, it should theoretically remain effective even in cases where resistance develops in patients," he noted. The approval of onradivir marks China's fourth approved anti-influenza drug, expanding the therapeutic arsenal available to clinicians.
Global Health Impact
The approval addresses a substantial global health burden. Influenza affects approximately 1 billion people worldwide annually, including 3 to 5 million severe cases, resulting in 290,000 to 650,000 deaths each year. The National Medical Products Administration emphasized that "the approval of this medication provides patients with a new treatment option" in tackling this significant public health challenge.
Li Tongzeng expressed optimism about the drug's potential impact, stating, "When the next flu season arrives, we'll have another weapon in our hands." The development represents what Raynovent characterizes as "a Chinese solution to tackling global influenza epidemics," potentially offering new hope for improved influenza management worldwide.
