July 18, 2025, Nanjing Zenshine Pharmaceutical Co., Ltd (Hereinafter referred to as “Zenshine Pharma”) announced that its self-developed novel PA endonuclease inhibitor anti-influenza drug Sebaloxavir Marboxil Tablets has officially received marketing approval from China's National Medical Products Administration (NMPA) for the treatment of uncomplicated influenza in adults.

The approval for this indication was based on a multicenter, randomized, double-blind, placebo-controlled phase II/III seamless adaptive trial designed to evaluate the efficacy and safety of the drug compared to placebo in adults with uncomplicated typical influenza. This study met its primary and secondary endpoints, with statistically significant and clinically meaningful benefit. Sebaloxavir Marboxil Tablets requires only one dose for the entire duration of illness. In the treatment group, the median time to remission of influenza symptoms was 39.4 hours, which was significantly shorter than the 62.9 hours observed in the placebo group (P < 0.001). The median time for influenza RNA to become undetectable was 41.4 hours, significantly lower than the 90.7 hours in the placebo group. In terms of the speed of symptom relief, fever subsided in the treatment group after an average of 23.6 hours, achieving fever resolution within one day.
Sebaloxavir Marboxil Tablets demonstrates a significant safety advantage, with clinical data showing a low incidence of adverse events (AEs), including only 0.3% gastrointestinal AEs. This effectively addresses the common clinical challenges of nausea, vomiting, and diarrhea associated with traditional anti-influenza drugs. Additionally, as Jike Shu is not metabolized via the CYP450 enzyme system, it exhibits a low risk of drug-drug interactions (DDIs), offering a safer therapeutic option for patients with multiple comorbidities and polypharmacy.


About Zenshine Pharma
Zenshine Pharmaceuticals is a commercialization-stage biopharmaceutical company, focused on small molecule therapeutics in the areas of cancer, viral infection and inflammation. Our mission is to apply the best science to serve patients. Zenshine Pharmaceuticals leverages the team's extensive expertise and experience in developing proprietary chemical entities with well-defined differentiation to benefit the patients. By targeting key biological pathways to disrupt virus replication, directly block tumor growth and enhance anti-tumor immune responses, Zenshine Pharmaceuticals commits to providing bench-side to bed-side solutions and delivering the best-in-class or first-in-class therapeutics.