IN026 is a potential first-in-class mRNA therapy for refractory gout, marking the official entry of DeepBio's independently developed mRNA-LNP platform into a new treatment category.

Hong Kong, Shenzhen, and Boston, USA – March 18, 2026 – Sangfor Biotech, a clinical-stage biotechnology company focused on RNA drug development, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its mRNA drug candidate, IN026, an investigational mRNA therapy for refractory gout. Following this IND approval, the company will systematically evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in a Phase 1 clinical trial in this unmet medical need patient population.

IN026 achieves systemic degradation of uric acid in vivo by delivering mRNA encoding uricase (UOX) to the liver.

“Refractory gout is a disease that can severely impact patients’ mobility and quality of life. Existing treatments are often limited in their effectiveness due to issues such as immunogenicity, tolerability, and attenuation of efficacy,” said Michael Beckert, Chief Medical Officer of DeepBio. “We are excited to advance IN026 into the clinical development stage. This is a key step we have taken to break through the current treatment bottlenecks and represents an important advancement in the field of potential first-in-class mRNA therapies.”

“Our initial motivation for founding DeepBio was our firm belief that mRNA, as a novel form of medicine, can address medical challenges that traditional drugs cannot handle,” said Dr. Li Linxian, founder and CEO of DeepBio. “With IN026 entering clinical development, we are opening a new chapter in mRNA-based protein replacement therapy, aiming to achieve repeated dosing and long-term management of chronic diseases.”

Regarding refractory gout

Refractory gout refers to gout that persists despite standardized uric acid-lowering drug treatment, characterized by recurrent attacks, the presence of progressive tophi, or failure to achieve target serum uric acid levels. This group of patients represents a significant unmet clinical need. It is estimated that there will be approximately 1.9 million patients with refractory gout worldwide in 2026, representing about 3% of all gout patients.

Regarding IN026

IN026 is an investigational mRNA therapy designed to treat refractory gout. It delivers mRNA encoding uricase (UOX) to the liver, utilizing the expressed UOX to promote the systemic degradation of uric acid in the body. Based on Deepin Biotech's independently developed mRNA-LNP (messenger ribonucleic acid-lipid nanoparticle) technology platform, specifically designed for repeated dosing and long-term disease control, IN026 holds promise as a potential first-in-class mRNA protein replacement therapy for refractory gout and other chronic metabolic diseases.

Regarding Deepin Bio

Sangfor Biotech is a clinical-stage biotechnology company dedicated to improving the lives of patients worldwide by accelerating a virtuous cycle of platform and pipeline innovation, driving the development of RNA drugs. Leveraging its deep and continuously expanding intellectual property portfolio, the company has successfully built its own RNA delivery and engineering platform, possessing over 6,000 chemically diverse ionizable lipid libraries, targeted LNP delivery systems, and cutting-edge mRNA technologies. With its vertically integrated capabilities from drug discovery to cGMP manufacturing, Sangfor Biotech has significant advantages in technological depth, development speed, and capital efficiency. The company is advancing a rich mRNA R&D pipeline covering multiple areas, including chronic disease treatment, in vivo immunotherapy, and vaccines. To date, Sangfor Biotech has raised a total of US$150 million, which can support the advancement of key clinical milestones. Simultaneously, the company is actively seeking strategic financing and partners to further expand its R&D pipeline.

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