Innovative Drug SAL0145 Injection Clinical Trial Application Accepted: siRNA Therapy May Bring New Hope for MASH Treatment

In recent years, with the rapid advancement of nucleic acid drug technologies, small interfering RNA (siRNA) therapeutics have emerged as one of the most promising directions in global innovative drug development. Recently, Shenzhen Salubris Pharmaceuticals announced that the clinical trial application for its independently developed innovative drug SAL0145 Injection has been accepted by the National Medical Products Administration (NMPA). This marks an important milestone as the drug officially enters the clinical research stage, offering a potential new therapeutic option for metabolic liver diseases.

SAL0145 is primarily intended for the treatment of Metabolic Dysfunction‑Associated Steatohepatitis (MASH), a chronic liver disease whose global incidence has been rising rapidly in recent years and which has become a major focus of innovative drug research.

Preclinical Data: SAL0145 Shows Potential Therapeutic Value

Publicly available data suggest that SAL0145 demonstrated encouraging results in several key indicators during preclinical studies:

1️⃣ Significant reduction in hepatic lipid accumulation

Animal studies showed that SAL0145 significantly reduced triglyceride levels in the liver and decreased fat deposition.

2️⃣ Improvement in liver inflammation

Research indicates that SAL0145 can suppress inflammation-related signaling pathways and reduce inflammatory cytokine levels, thereby alleviating liver inflammation.

3️⃣ Decrease in fibrosis markers

In certain experimental models, the drug reduced biomarkers associated with liver fibrosis, suggesting the potential to slow disease progression.

4️⃣ Sustained gene-silencing effect

The siRNA mechanism enables long-lasting suppression of gene expression, which may allow for less frequent dosing and improved treatment adherence.However, these findings are based primarily on preclinical models, and the actual therapeutic effect must still be validated through human clinical trials.

MASH: A Major Global Challenge in Metabolic Liver Disease

Metabolic Dysfunction‑Associated Steatotic Liver Disease (MASLD) is one of the most common chronic liver diseases worldwide, and MASH represents the inflammatory and progressive stage of this condition.

Global epidemiological data indicate:

● Approximately 25–30% of adults worldwide are affected by MASLD

● About 20% of patients may progress to MASH

● Among MASH patients, 15–25% may eventually develop liver cirrhosis

By 2030, MASH is expected to become one of the leading causes of liver transplantation worldwide.

Despite the growing disease burden, effective pharmacological treatment options remain limited, making innovative therapies with novel mechanisms highly anticipated.

siRNA Drugs: A New Generation of Precision Medicine

SAL0145 belongs to the class of siRNA therapeutics, which utilize RNA interference to degrade target messenger RNA (mRNA) at the post-transcriptional level, thereby preventing the production of disease-related proteins.

In recent years, siRNA drugs have achieved important breakthroughs across multiple therapeutic areas. For example:

● Patisiran – the world’s first RNAi therapy, approved for hereditary transthyretin-mediated amyloidosis

● Inclisiran – used to reduce low-density lipoprotein cholesterol (LDL-C)

● Givosiran – approved for the treatment of acute hepatic porphyria

These successful cases demonstrate that RNAi technology is gradually becoming a major innovative drug platform alongside monoclonal antibodies and antibody-drug conjugates (ADCs).

Global Significance of SAL0145 Development

The progression of SAL0145 into the clinical application stage not only represents an important milestone for the company but also highlights China’s growing capabilities in nucleic acid drug development.

Its global significance can be seen in several aspects:

1️⃣ Advancing innovation in MASH treatment

There remains a substantial unmet medical need in the MASH treatment field, and therapies with new mechanisms could offer significant clinical benefits.

2️⃣ Accelerating China’s siRNA drug development

The advancement of SAL0145 reflects the increasing research and development capabilities of Chinese biotech companies in RNAi technology platforms.

3️⃣ Strengthening global competition in metabolic disease therapeutics

With the rapid rise in metabolic disease prevalence, the global MASH drug market is projected to reach tens of billions of dollars in the coming years.

4️⃣ Expanding the global RNAi drug pipeline

The discovery of additional targets and innovative molecules will further promote the application of RNAi therapies in chronic disease treatment.

Future Outlook

The acceptance of the clinical trial application for SAL0145 marks a key milestone in its development. As clinical trials progress, more data on the drug’s safety, tolerability, and efficacy will gradually emerge.

If future studies demonstrate positive outcomes, SAL0145 may become an important innovative therapy in the MASH treatment landscape and provide new treatment options for patients worldwide.

Meanwhile, as the global pharmaceutical supply chain continues to evolve, international drug supply platforms are also closely monitoring the development of emerging therapies. For instance, Dengyue Pharma has been tracking global advances in innovative treatments—including nucleic acid drugs, targeted oncology therapies, and rare disease medications—while providing international drug information and supply services for healthcare institutions and patients.