Shenjie® (Monosialotetrahexosyl Ganglioside Sodium Injection) Granted New Indication for Acute Ischemic Stroke Based on High-Level Evidence

Dec 17, 2025 19:36 CST Updated 19:36

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

On November 11, 2025, the National Medical Products Administration officially approved Qilu Pharmaceutical's Sodium Ganglioside Injection (trade name: Shengjie).^®) for the treatment of Acute Ischemic Stroke (AIS). This approval marks a new phase in the application of this product within the field of cerebrovascular disease treatment, based on high-level evidence from evidence-based medicine and precise indication guidance, providing clinicians and patients with a new therapeutic option.

FOCUS Study Confirms

Gangliosides Significantly Improve Long-term Prognosis in Patients with Acute Ischemic Stroke

Shenjie^®(Sodium Monosialotetrahexosylganglioside,GM1) A Randomized, Double-blind, Placebo-controlled Phase III Study (FOCUS Study) for the Treatment of Acute Ischemic Stroke (AIS), led by Professor Xu Yun from Gulou Hospital Affiliated to the Medical School of Nanjing University, was conducted across 68 centers in China. The study enrolled 1,232 participants. Its rigorous design and sufficient sample size of participants provide high-level evidence-based medical support for scientifically verifying the efficacy and safety of the drug.

InAt the 2025 World Stroke Congress (WSC), the results of the FOCUS study were presented at the Plenary, Award & Late Breaking Session. The Plenary, Award & Late Breaking Session is a core part of WSC’s academic exchange, specifically showcasing the latest clinical research findings or breakthrough technologies. On behalf of Professor Xu Yun, the leading Principal Investigator (PI) in China from the Affiliated Drum Tower Hospital of Nanjing University Medical School.，Professor Zhang Xin from the Affiliated Drum Tower Hospital of Nanjing University Medical School, on behalf of the research teamShared the research results at the conference现场。

Professor Zhang Xin from the Affiliated Gulou Hospital of Nanjing University Medical SchoolWSC Reports Research Findings

Studies show that, on the basis of standard treatment, the early addition ofShenjie^®(Daily100mg, course of treatment 12-14 days), can significantly improve the long-term functional prognosis of patients. In terms of the primary efficacy endpoint, based onIn the mFAS population (Shenjie group n=516, placebo group n=503), the proportion of patients with an mRS score ≤2 at day 90 was 67.6% (349/516) in the Shenjie group, significantly higher than 57.5% (289/503) in the placebo group, P=0.0007.This means that more patients are able to regain independent living, significantly reducing the risk of disability.At the same time, the study confirmed its good safety profile, with comparable incidence of adverse events between the treatment group and the placebo group. No serious adverse events of special concern occurred during the study (Guillain- Barre syndrome and anaphylactic shock).

FOCUS Study as a Rigorously Designed Large-Scale Registrational Randomized Controlled Trial Provides High-Level Evidence for the Efficacy and Safety of Monosialotetrahexosylganglioside Sodium in the Early Treatment of Patients with Moderate to Moderately Severe Acute Ischemic Stroke. Based on this high-level evidence,Shenjie^®The approval of this new indication marks its more precise clinical application goal — focusing on the treatment of acute ischemic stroke.

Focus on Core Dosage Forms, Meeting Urgent Clinical Needs

The selection and development strategy of drug dosage forms represents the deep integration of scientific research and clinical needs. Qilu Pharmaceutical conducted a scientific evaluation and strategic focus on the ganglioside sodium product, aiming to concentrate resources to ensure that the core dosage form meets the highest quality standards. The recently approved "injection" dosage form is a result of this strategy. Compared with the "powder injection" form, the "injection" allows nurses or intravenous admixture centers to reduce handling and quickly prepare the medication, meeting the urgent clinical need for rapid and precise drug delivery within the "golden treatment window" for patients with acute ischemic stroke, providing doctors with a more direct and efficient treatment tool. This decision reflects Qilu Pharmaceutical's long-term commitment to optimizing the product life cycle and serving patients with the best therapeutic solutions.

Whole Life Cycle Quality Management

Safeguarding Patients' Long-term Medication Safety

One millionth of an enterprise is one hundred percent of a patient. Qilu Pharmaceutical Co., Ltd. has established a high-standard quality management system covering the entire lifecycle from raw materials to finished products. Notably,Shenjie^®The preparation process has won"Second Prize of National Science and Technology Progress Award". The internal control standards of the company are much higher than the legal registration standards, ensuring the high purity and low impurity levels of the products from the source. This provides a fundamental guarantee for the good safety observed in clinical applications. In addition, Qilu Pharmaceutical Co., Ltd. has established a comprehensive pharmacovigilance and continuous safety monitoring system to closely track and scientifically evaluate the safety of products after they enter the market, safeguarding patients' long-term medication safety.

Data Source: Qilu Pharmaceutical

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