PegBio Announces Successful First-in-Human Trial of Next-Generation GLP-1 Drug CR059

Key Milestone Achieved in the Development of Circular RNA-Based Drug for Diabetes and Metabolic Diseases

Hong Kong, March 6, 2026 — PegBio Co., Ltd. (Stock Code: 2565) has announced a significant milestone in its pipeline, with the completion of a first-in-human (FIH) trial of its next-generation GLP-1 receptor agonist, CR059. The company has obtained one-month clinical observation data, marking a potential breakthrough in the treatment of type 2 diabetes and other chronic metabolic diseases.

Highlights of the Announcement

• CR059 is a novel GLP-1 receptor agonist developed using PegBio’s proprietary circular RNA (CircRNA) protein replacement platform and AI-assisted molecular design.
• The FIH study was designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of CR059 in patients with type 2 diabetes mellitus (T2DM).
• One-month human clinical data show sustained metabolic improvements after a single dose, including reductions in glycated hemoglobin (HbA1c), fasting blood glucose, and mean blood glucose, along with increased time in range (TIR) for blood glucose control.
• CR059 uses a lipid nanoparticle (LNP) delivery system to enable long-acting metabolic intervention, potentially allowing for monthly or low-frequency dosing and improved patient adherence.
• The CircRNA platform enables efficient, sustained in vivo expression of therapeutic proteins, potentially transforming the treatment model for chronic diseases by reducing the need for frequent exogenous drug administration.

Preclinical Data Underscore Platform Promise

In head-to-head preclinical studies:

• In db/db mice, CR059 demonstrated superior metabolic intervention compared to semaglutide, showing a clear dose-response and stable GLP-1 receptor activation.
• In spontaneous type 2 diabetic rhesus monkeys, monthly subcutaneous injections led to significant and sustained reductions in fasting plasma glucose and continued improvement in HbA1c over an 88-day period, supporting extended dosing intervals.
• In healthy rhesus monkeys, a single dose of CR059 maintained metabolic benefits for several weeks, including a notable weight loss of approximately 11.8% five weeks post-administration. This further strengthens the case for durable, low-frequency dosing.

First-in-Human (FIH) Study: Detailed Results

• After a single administration in human subjects with T2DM, continuous improvements were observed in HbA1c and fasting blood glucose at four weeks compared to baseline.
• Continuous glucose monitoring (CGM) confirmed increased TIR (4-10 mmol/L) and an overall improvement in blood glucose control.
• The metabolic improvement trend continued over the observation period, supporting the potential for low-frequency dosing and long-term disease management through sustained in vivo protein expression.

Platform Strengths and Strategic Importance

• PegBio’s circular RNA platform does not require exogenous ligases or chemical modifications, relying instead on optimized codon structure and translation-enhancing sequences.
• The platform enables stable and prolonged protein translation without the need for a 5’ cap or poly(A) tail.
• This design is expected to extend the duration of therapeutic protein expression in vivo, potentially revolutionizing chronic disease treatment by reducing injection frequency and improving patient compliance.

Implications for Shareholders and Investors

• This is a major milestone for PegBio, validating its circular RNA platform in human subjects and marking a potential inflection point for company valuation and market positioning.
• If subsequent trials confirm safety and efficacy, CR059 could become a market-leading therapy for diabetes and other metabolic diseases, challenging established products like semaglutide and driving significant commercial value.
• The company’s technology also opens up the possibility of developing additional long-acting biologics for other chronic indications, creating a broad pipeline opportunity.

Risks and Forward-Looking Statements

• PegBio notes that there is no guarantee CR059 will be successfully developed or commercialized.
• Investors should exercise caution, as future clinical results and regulatory pathways may impact the program’s success and the company’s share price.

Conclusion

The successful completion of the first-in-human trial for CR059 and the positive one-month human data represent a potentially transformative event for PegBio. The company’s advancement of circular RNA-based protein replacement therapies could reshape the treatment landscape for chronic metabolic diseases and drive substantial value for shareholders—contingent on continued clinical success.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult with professional advisors before making investment decisions. The future success of CR059 and PegBio’s pipeline depends on further clinical validation, regulatory approval, and market acceptance.

View PEGBIO CO-B Historical chart here