uBriGene Biosciences International Co. announced a strategic partnership with Circurna, a biotechnology company developing next‑generation circular RNA (circRNA) therapeutics. Under the agreement, uBriGene will provide end‑to‑end services for circRNA drug substance (DS) and drug product (DP), including process and analytical method development, scaled‑up manufacturing, and GMP‑grade delivery.
Transaction Overview
| Component | Details |
|---|---|
| Partnership Scope | End‑to‑end CMC services for circRNA DS/DP |
| uBriGene Services | Process development, analytical methods, scaled manufacturing, GMP delivery |
| Circurna Platform | Programmable circularization, advanced RNA engineering, targeted delivery |
| Strategic Goal | Accelerate R&D pipeline to First‑in‑Human (FIH) trials; build scalable CMC system |
| Leverage | uBriGene’s global manufacturing network and cross‑regional regulatory expertise |
| Quality & Compliance | Robust quality system, process reproducibility, multi‑country submission readiness |
Technology Platforms
| Company | Platform | Application |
|---|---|---|
| Circurna | Proprietary circRNA technology | Next‑gen RNA therapeutics for unaddressed diseases |
| uBriGene | Global manufacturing & regulatory network | Ensures GMP compliance and global development support |
Strategic Implications
- For Circurna: Partnership provides immediate CMC capabilities without capital investment; leverages uBriGene’s regulatory experience to navigate US, EU, and China submissions; accelerates FIH trial readiness for novel circRNA pipeline.
- For uBriGene: Secures anchor client in emerging circRNA space; expands service portfolio into next‑generation RNA modalities; demonstrates ability to support global biotechs from early‑stage to commercialization.
- For Market: circRNA therapeutics projected to capture $5‑8 billion by 2035; partnerships between platform companies and CDMOs are critical to overcome manufacturing bottlenecks and enable rapid translation.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the partnership’s ability to advance Circurna’s pipeline to FIH trials, manufacturing scalability, and market potential for circRNA therapeutics. Actual results may differ due to technical risks, regulatory delays, or competitive dynamics.-Fineline Info & Tech
