NMPA Approves Jike Shu (Sebaloxavir Marboxil Tablets) 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. Jike Shu (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.

Jike Shu (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.

Porton Pharma Solutions Ltd.(Hereinafter referred to as “Porton” or the company) provided a full set of pharmaceutical and quality research services for Jike Shu ’s active pharmaceutical ingredients(API) throughout its clinical development and commercialization phases. The company successfully completed the delivery of Non-GMP batches, key clinical batches, and validation batches of the project in an outstanding way. The clear division of work and tight collaboration between all departments in Porton have provided solid guarantee for the production quality, operational safety and cost efficiency of the project, and their performances were highly recognized by the CMC team from the client–fully affirming the excellence capabilities of the project team in terms of process/quality research, production delivery, project governance and quality system management.

Porton R&D team efficiently executed process optimization, impurity control and crystallization process development, laying a solid foundation for the successful delivery of the Non-GMP batch and registered batch; Porton project management team has quick respond to needs of the client, and ensured on time delivery of urgent tasks through efficient resource coordination; Porton technical and production teams strengthened cross-departmental communication, ensure on time production and processing of materials. The complete quality system won high praise from the client. Through end-to-end excellence spanning R&D, project management, technical, production and quality, Porton successfully supported the market approval of Jike Shu (Sebaloxavir Marboxil Tablets).

As a global leading CDMO, Porton is consistently committed to providing end-to-end CMC solutions with high-quality services, spanning from process route exploration and optimization, pilot scale to commercial production, as well as quality research and CMC regulatory support. Leveraging two decades of proven expertise in serving global innovator drug development, Porton actively empowers China’s biopharmaceutical industry by collaborating with domestic pharmaceutical companies to accelerate industry advancement. Together, we will enable more innovative drugs to progress into pivotal clinical trials and secure market approval faster, thus enabling the public’s early access to good medicines.

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