Developing accessible CGT products to meet urgent unmet medical needs.

Company Overview

Regenelead was founded with the aspiration to develop accessible CGT products to meet urgent unmet medical needs by focusing on innovation and building a diversified pipeline that well balances innovation and certainty.

The company has established AI-powered comprehensive technical platforms of AAV, mRNA, cell therapy, and in vivo CAR-T, which enable us to consistently generate highly differentiated, best-in-class therapeutic candidates. We have 20+ R&D pipelines and 11 IND approvals, e.g. RGL-270 is China’s first personalized mRNA tumor vaccine to receive IND clearance, and RGL-2102(T) is the world’s first topical mRNA therapeutic.

Our core team consists of world-class scientists with end-to-end expertise spanning CGT products from early discovery, process development, clinical study to manufacturing. Together, we strive to build a healthier life for patients worldwide.

Office
We have four R&D and manufacturing sites across Shanghai, Guangzhou and Chongqing, covering the entire product lifecycle from discovery and development to manufacturing. One site is a postdoctoral workstation accelerating innovation and clinical translation.
Shanghai R&D Innovation Center ≈15000㎡
Shanghai Jinqiao Innovation Center ≈1500㎡
Guangzhou Revolead ≈10000㎡
MILESTONES

Our Journey

2021
  • Founded and focused on the development of CGT therapies
  • Our first PCC of AAV and mRNA has been established
2022
  • Construction of AAV pilot facility completed and ready for commissioning and production
  • First 200L scale-up production successfully delivered
2023
  • The launch of IIT for our personalized mRNA cancer vaccine marks the transition from preclinical research to clinical development
2024
  • 3 IND approvals for innovative programs
    • RGL-2102 for injection: World's first mRNA protein replacement therapy for CLI
    • RGL-2102(T): World's first topical mRNA therapy for chronic wounds
    • RGL-193: First-in-class dual-gene AAV therapy for Parkinson's disease
  • Guangzhou Revolead founded
2025
  • Multi-cohort Phase II trials initiated for both injectable and topical RGL-2102
  • More pipelines advanced to the IND stage
    • RGL-270: China's first personalized mRNA cancer vaccine with IND approval
    • RGL-232: Off-the-shelf KRAS-targeted cancer vaccine
    • RGL-2201: First dual-target gene therapy for macular degeneration
    • RGL-305: Our first cell therapy candidate
2026
  • Commercial-scale facility completed
  • Major clinical breakthrough for RGL-270, a personalized cancer vaccine
  • IND approval for RGL-236, an mRNA therapy for osteoarthritis
  • IND approval for RGL-185, an AAV gene therapy for radiation-induced xerostomia
Future
  • Successful commercialization of multiple products
  • To be a World-Class cell and gene therapy biotech
Our Awards
National High-Tech Enterprise
Shanghai Specialized, Refined, Differential and Innovative SMEs (SRDI SMEs)
2025 National Science and Technology Major Project for Prevention and Treatment of Cancers, Cardiovascular and Cerebrovascular, Respiratory, and Metabolic Diseases
Shanghai Innovative SMEs
2024 National Science and Technology Major Project for Prevention and Treatment of Cancers, Cardiovascular and Cerebrovascular, Respiratory, and Metabolic Diseases
2025 China Potential Unicorn Enterprise
2025 China Biomedical Science and Technology Innovation Value List
Top 10 Most Promising CGT Enterprises
2025 GEI China “Rising Star in Science & Innovation” Enterprise