The application for the NDA of the new anti-influenza drug GP681 tablets was accepted by NMPA

On November 24, the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the marketing application for GP681 tablets, a Class 1 innovative chemical drug registered and submitted by Qingfeng Pharmaceutical/Kerui Pharmaceuticals, a subsidiary of Qingfeng Pharmaceutical, was accepted by the NMPA and received a "Notice of Acceptance".

GP681 tablets are an innovative anti-influenza virus drug jointly developed by Qingfeng Pharmaceuticals and Ginkgo Tree Pharmaceuticals. It is a polymerase acidic protein (PA) inhibitor. GP681 is a prodrug that is converted into an active metabolite GP1707D07 by hydrolysis, selectively inhibiting the cap-dependent nuclease of influenza virus PA, thereby inhibiting the replication of influenza virus.

Influenza, also known as flu, is an acute respiratory infectious disease caused by influenza viruses. Influenza A and B viruses are seasonally prevalent each year, and influenza A viruses can cause global pandemics. According to statistics from the World Health Organization, during an outbreak, influenza can spread rapidly throughout the world, affecting 10%-20% of the total population. Even in years without an outbreak, seasonal influenza causes approximately 3-5 million severe cases and 290,000-650,000 deaths each year worldwide.

According to the Centers for Disease Control and Prevention (CDC), since 2010, the flu season has caused 9.3-45 million illnesses, 140,000-810,000 hospitalizations, and 12,000-61,000 deaths each year. The CDC preliminarily estimates that the number of illnesses in the 2019-2020 flu season (October 1, 2019-April 4, 2020) will be approximately 39-56 million, the number of hospitalizations will be approximately 410,000-740,000, and the number of deaths will be approximately 24,000-62,000.

According to relevant research, the average total economic burden of influenza on the US healthcare system and society is $11.2 billion (US$630 million to $25.3 billion) each year, with an estimated direct medical cost of $3.2 billion (US$150 million to $5.17 billion) and indirect medical costs of $8 billion (US$480 million to $13.6 billion). Localized epidemics of seasonal influenza, the emergence of highly pathogenic avian influenza, and the outbreak of pandemic influenza pose a huge threat to the world's public health system. As influenza viruses mutate, existing anti-influenza drugs face severe drug resistance challenges. In view of the huge threat of influenza, the development of antiviral drugs for influenza has always been a research hotspot.

According to the results of Phase I, Phase II, and Phase III clinical studies, as a new mechanism of action of endonuclease inhibitors, GP681 tablets have the characteristics of strong efficacy, low dosage, and good drug resistance. The drug can cure influenza within one day with just one dose, and can last for more than one week. After the drug is approved for marketing, it will provide the latest and best treatment options for domestic influenza patients.

Keep going and the future is promising. The successful application for GP681 tablets being accepted by the National Medical Products Administration is the result of Qingfeng Pharmaceuticals' insistence on R&D-driven and open cooperation. In the future, Qingfeng Pharmaceuticals will continue to uphold the concept of joint efforts and collaborative innovation, and work with partners to inject Chinese power into the development of innovative drugs.