By Fineline Cube 
Youcare Pharmaceutical Group (SHA: 688658) announced that the U.S. Food and Drug Administration (FDA) has approved its clinical‑trial application for YKYY013 injection, a next‑generation small‑interfering RNA (siRNA) therapy designed to treat chronic hepatitis B virus (HBV) infection.
About YKYY013
- Mechanism of Action – YKYY013 is a chemically synthesized, double‑stranded siRNA conjugated to an N‑acetylgalactosamine (GalNAc) ligand. The GalNAc moiety targets hepatocytes, delivering the siRNA to the liver where it silences key HBV genes via RNA interference.
- Functional Cure Goal – By suppressing viral replication and reducing production of hepatitis B surface and core antigens, YKYY013 aims to achieve a functional cure—defined as sustained loss of hepatitis B surface antigen (HBsAg) and undetectable HBV DNA.
- Broad Genotype Coverage – Preclinical studies demonstrate potent antiviral activity across all ten HBV genotypes (A–J), positioning YKYY013 as a universal therapeutic candidate.
FDA Approval Milestone
- Clinical‑Trial Readiness – The FDA clearance confirms that preclinical data satisfy regulatory standards for human testing, allowing Youcare to initiate Phase 1/2 studies in the United States.
- Strategic Impact – This approval marks a critical step toward global commercialization, opening the door for collaboration with U.S. sponsors and access to the largest hepatitis B market.
Market Implications
- Competitive Landscape – YKYY013 enters a growing portfolio of siRNA‑based hepatitis B candidates, offering a unique GalNAc‑conjugated delivery platform that may improve safety and efficacy profiles relative to existing nucleos(t)ide analogues.
- Regulatory Momentum – FDA approval enhances Youcare’s credibility among U.S. payers and regulators, potentially accelerating reimbursement and market penetration.
- Expansion Potential – Successful clinical outcomes could extend YKYY013’s application to other viral hepatitis indications, leveraging the same RNA‑interference platform.-Fineline Info & Tech