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WHAT IS THE REGEND003?
REGEND003 is a pioneering regenerative therapy to restore kidney structure and function, offering a potential fundamental solution to renal failure. This product utilizes the intrinsic regenerative capacity of urine-derived progenitor cells to treat patients with CKD, whose kidneys have been severely injured and lost its own recovery ability.
Derived non-invasively from urine, kidney progenitor cells are expanded in vitro and reintroduced into kidney injury sites, where they drive functional regeneration of tubular and glomerular cells through dual mechanisms of differentiation and paracrine signaling, ultimately repairing renal structure and enhancing kidney function.
Mechanism of Action: Regenerative Repair and Paracrine Modulation via Autologous Kidney Progenitor Cells
REGEND003 consists of high-purity kidney progenitor cells with intrinsic renal regenerative potential, enabling targeted repair of damaged nephrons without risk of immunogenicity.
Following administration, transplanted kidney progenitor cells engraft within the renal parenchyma at injury sites and differentiate into mature, functional kidney epithelial cell, thereby directly reconstructing damaged renal epithelium and restoring kidney function.
Beyond direct differentiation for regeneration, administered kidney progenitor cells exert paracrine effects by interacting with endogenous cells in injured regions. Through secretion of bioactive factors, they regulate key renal regenerative signaling pathways suppress local fibrosis, accelerate renal functional recovery, and drive comprehensive tissue repair.
Market Opportunity: The Significant Unmet Clinical Need in Chronic Kidney Disease (CKD)
CKD. CKD is a syndrome characterized by persistent alterations in kidney structure, function, or both, which adversely affect an individual’s health. As of 2024, there were approximately 145.8 million patients with CKD in China, and CKD has become a leading contributor to end-stage renal disease (ESRD) and related mortality. Current standard treatments can only mitigate risk factors and slow disease progression. They fail to reverse nephron loss, repair damaged kidney tissue, or halt the irreversible decline of kidney function, leaving a critical unmet clinical need for innovative therapies.
Clinical Development: REGEND003 Has Received IND Approval and Entered Phase I Clinical Trial
REGEND003 has been approved for IND by NMPA. We have initiated Phase I clinical trial and dosed the first CKD patient. It is expected to become one of the first effective drug treatment options for CKD through regeneration.