Beijing News (Reporter Wang Lu) Qilu Pharmaceutical announced on July 3 that the anti-infective drug Peramivir Injection had recently been approved for marketing by the National Medical Products Administration and is deemed to have passed the consistency evaluation.
Peramivir is a new generation of neuraminidase inhibitor, which can selectively inhibit the neuraminidase of human influenza A and B viruses, suppress the mature influenza virus from detaching from the host cell, thereby inhibiting the spread of influenza virus in the human body to treat influenza. It can be used to treat influenza A or B patients of all age groups.
Seasonal influenza caused by the influenza virus occurs annually, with high-risk groups such as the elderly, young children, pregnant women, obese individuals, and those with chronic underlying diseases being more prone to complications like pneumonia. Some individuals with chronic underlying diseases may experience an exacerbation of their conditions, potentially developing into severe cases that can be life-threatening. Peramivir Injection is effective against the influenza virus, with characteristics including rapid onset, prolonged efficacy, and ease of use for critically ill patients. The availability of Peramivir Injection provides a new treatment option for patients with severe influenza or those unable to undergo oral medication therapy.
Qilu Pharmaceutical stated that the approval and market launch of Peramivir Injection will add another significant product to the anti-infective drug pipeline, forming an anti-influenza virus product line together with the already approved and marketed Oseltamivir Capsules and Oseltamivir Powder for Suspension.
Data shows that the original research drug of Peramivir Sodium Chloride Injection was first approved for marketing in Japan in August 2011. In March 2011, the predecessor of Nanxin Pharmaceutical, Kaibo Biotech, introduced Peramivir and took the lead in its development. On April 5, 2013, Nanxin Pharmaceutical's Peramivir received accelerated approval for marketing in China. However, Nanxin Pharmaceutical had cautioned in its STAR Market listing announcement that while it had obtained a patent for the synthesis method of Peramivir trihydrate in China, it did not acquire authorization for the Peramivir trihydrate patent domestically, posing a risk of the product being copied in China. At that time, three pharmaceutical companies had already begun clinical research on Peramivir drugs, and two pharmaceutical companies had obtained clinical trial approvals for Peramivir drugs.
In March this year, Zhongrun Pharmaceutical's Peramivir Injection was approved for marketing, becoming the first domestically produced generic drug in China and is considered to have passed the consistency evaluation. Yangtze River Pharmaceutical is the second company to obtain the generic drug approval for this variety. In addition to Zhongrun Pharmaceutical and Yangtze River Pharmaceutical, several other companies, including Wuhan Humanwell, Fuan Pharmaceutical, Yanghe Pharmaceutical, and Huluwa Pharmaceutical, have submitted marketing applications for Peramivir.
Proofread by Chunyin Fu