Xofluza® (Baloxavir Marboxil) Included in China's 2021 National Reimbursement Drug List Eight Months After Approval

Shanghai, December 3, 2021 /PRNewswire/ -- On December 3, 2021, the National Healthcare Security Administration issued the latest announcement that Roche's new anti-influenza drug, Xofluza® (Chinese generic name: Baloxavir Marboxil), officially entered the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2021 Edition)" eight months after its approval in China.》。

Xofluza® (Baloxavir Marboxil) is an innovative cap-dependent endonuclease inhibitor, and it is the first new drug approved for the treatment of influenza in 20 years.The first and only single-dose oral medication。A single dose of Baloxavir Marboxil can significantly reduce viral shedding within 24 hours, shorten the contagious period, and substantially reduce the duration of flu symptoms.

In November 2020, due to its "involvement in public health, severe influenza endangering life, and having a therapeutic advantage over marketed products”, Xofluza (Baloxavir Marboxil) was included in the "List of Overseas New Drugs Urgently Needed Clinically (Third Batch)" and received priority review status from the National Medical Products Administration. In April 2021, Xofluza (Baloxavir Marboxil) was officially approved by the National Medical Products Administration for the treatment of patients aged 12 years and above with acute, uncomplicated influenza, including those at high risk of influenza complications.

Influenza is an acute respiratory infectious disease caused by the influenza virus. Globally, influenza causes about 5%-10% of adults and 20%-30% of children to be infected each year, resulting in up to 5 million severe cases and 650,000 deaths. In China, the annual average number of respiratory disease-related deaths due to influenza is 88,000, accounting for 8.2% of respiratory disease-related deaths, posing a significant threat to public health.

China's National Health Commission Releases "Diagnosis and Treatment Protocol for Influenza (2020 Edition)" Indicates That Antiviral Treatment Within 48 Hours of Onset Can Reduce Complications and Lower Mortality Rate. "Once Infected with Influenza, It Is Recommended to Seek Medical Attention Early and Receive Appropriate Antiviral Treatment Promptly."”Professor Mei Zeng, Deputy Director of the Department of Infectious Diseases at the Children's Hospital of Fudan UniversityPoint out.

"Unlike previous anti-influenza drugs targeting neuraminidase (such as oseltamivir), baloxavir marboxil inhibits viral replication by suppressing the cap-dependent endonuclease of the influenza virus, exerting its effects early in the replication process and blocking viral replication more rapidly. With just a single dose, it can quickly suppress viral shedding within 24 hours, shorten the contagious period, and significantly reduce the duration of flu symptoms, allowing patients to return to their normal work, study, and life more quickly. It has high medication compliance and a low probability of adverse reactions."”Zeng MeiProfessorPoint out.

"Ma Baloxavir's inclusion in the medical insurance catalog provides an important supplement to existing influenza clinical treatment options, which will significantly alleviate the pressure on medical resources during the pandemic and reduce the possibility of multiple viruses cross-infecting within a unit or household care setting," pointed out Professor Xu Jie. Recently, China’s National Health Commission emphasized that both COVID-19 and influenza should be jointly prevented and managed during the flu season. "Under the severe situation of 'dual outbreaks' of influenza and the coronavirus, the rapid inclusion of this highly effective innovative anti-influenza drug into the national medical insurance catalog just eight months after its approval for marketing in China not only greatly reduces patients' financial burden but also demonstrates the role and value of innovative drugs in infectious disease prevention and control, adding another layer of protection to public health efforts."”Director of the Department of Infectious Diseases, Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineProfessor Xu JieRepresentation.

President of Roche Pharmaceuticals China, Bian Xin"We are delighted to see that Xofluza has been successfully included in the medical insurance through negotiation just eight months after its approval. This not only reflects the efforts made by the country to benefit more patients, but also serves as a clear example of the government and enterprises working hand-in-hand to promote the development of China's public health initiatives. Roche will always adhere to the philosophy of 'acting on patients' needs first,' and continue to actively support and cooperate with the country’s efforts to deepen the reform of the medical and healthcare system, further improving the accessibility and affordability of medicines, contributing to the realization of the grand blueprint of 'Healthy China 2030.'"”

According to the requirements of national documents, the new version of the medical insurance directory will be officially implemented on January 1, 2022.