Recently, the National Medical Products Administration officially approved the marketing of the Class 1 innovative drug Maseloxavir Tablets (trade name: Jikeshu) submitted by Nanjing Zhengxiang Pharmaceutical Co., Ltd. It is suitable for previously healthy adult patients with simple influenza A and B (excluding those at high risk of complications).

Influenza A and B viruses are seasonally prevalent every year, among which influenza A virus can cause a global pandemic. China's anti-influenza drug industry is growing rapidly. According to Yaozhi Data [Drug Full Terminal Sales Analysis System], in 2023, my country's anti-influenza drug sales in the country's three major terminals (public hospitals + retail pharmacies + e-commerce B2C) will exceed 20 billion yuan. In such a huge market context, Maseloxavir tablets will cause a huge sensation.

Maseloxavir tablets are a new-generation, globally proprietary inhibitor targeting the influenza virus RNA polymerase (PA) enzyme. They have rapidly gained recognition for their proven efficacy, including one-dose, one-day fever reduction, and safety.

The clinical study subjects for Maseloxavir tablets were all Chinese patients, making the drug more suitable for Chinese physiques. The results of a Phase II/III clinical study were recently published in Clinical Microbiology and Infection (Chinese Academy of Sciences, Region 1, IF=10.9), a leading infectious disease journal. Professor Zhang Wenhong, Director of the National Center for Infectious Diseases and Director of the Department of Infectious Diseases at Huashan Hospital, Fudan University, and Professor Zhu Huadong, Director of the Emergency Department at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, co-led the study.

Maseloxavir tablets were independently developed by Zhengxiang Pharmaceutical. Back in 2018, the world's first polymerase inhibitor, mabaloxavir (original drug), was approved in Japan and the United States. Zhengxiang Pharmaceutical keenly recognized the market potential of this novel mechanism of action and officially launched the Maseloxavir tablets development project in 2019. Yaozhi data shows that Zhengxiang Pharmaceutical submitted a new drug application to NMPA based on Phase II/III clinical data in February 2024. It took only 6 years from project initiation to market launch, demonstrating the full-chain capabilities of "rapid R&D + efficient transformation".

Yaozhi data shows that Jichuan Pharmaceutical and Zhengxiang Pharmaceutical entered into a strategic partnership in 2023, giving Jichuan Pharmaceutical exclusive promotion and sales rights for Jicoshu in mainland China. Jichuan Pharmaceutical, a leader in the research, development, production, and commercialization of respiratory and pediatric drugs, will further enhance the clinical accessibility of Maseloxavir tablets and break the long-standing reliance on imports for innovative anti-influenza drugs.

At present, the Phase 3 clinical study of maseloxavir tablets for the treatment of uncomplicated simple influenza in adolescents has submitted a new drug application (NDA). Several Phase 3 clinical studies on the efficacy and safety of uncomplicated simple influenza in children aged 5-11 are underway to meet the differentiated medication needs of patients.

The approval of Maseloxavir tablets for marketing is an important milestone in the research and development of anti-influenza drugs. It not only marks an important breakthrough in the innovative research and development of anti-influenza drugs in my country, but also provides a new "Chinese solution" for patients to deal with influenza.

Source：https://news.yaozh.com/archive/45821.html