February 08, 2024，Nanjing Zenshine Pharmaceuticals Co., Ltd. (Zenshine Pharma) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for Seloxavir Marboxil (ZX-7101A) for the treatment of uncomplicated influenza in Chinese adults. The filing is based a multicenter, randomized, double-blind, placebo-controlled phase 2/3 pivotal study (ZX-7101A-202, registration number: CTR20221729) to evaluate efficacy and safety of Seloxavir Marboxil. The phase 2/3 study enrolled a total of 900 Chinese adult patients with acute influenza infection, including 177 subjects in the phase 2 cohorts and 723 subjects in the phase 3 cohorts. The study met the primary and secondary endpoints.

ZX-7101A is a novel cap-dependent endonuclease (CEN) inhibitor developed by Zenshine Pharma. ZX-7101A has broad-spectrum antiviral activities against influenza A and B viruses and highly lethal avian influenza viruses. The drug has demonstrated favorable safety and efficacy in clinical trials.

“The CDE’s acceptance of this NDA represents a key milestone for Zenshine Pharma in its mission to bring Seloxavir Marboxil as a novel therapeutic option to patients with influenza infection. This achievement has been made possible by the dedication and skills of the Zenshine team with the constant support of the patients and investigators in the clinical trials.” said Dr. Jinfu Yang, Chairman of Zenshine Pharma. “We will continue to work closely with the regulatory agency during the review and expect ZX-7101A to be launched soon to help the infected individuals and to battle flu outbreaks. "