YOLT-101 / YolTech Therap, Shenzhen Salubris - LARVOL DELTA

YolTech Therapeutics Announces NMPA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH) (YolTech Press Release) - "YolTech Therapeutics...announced that The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has cleared the company’s Investigational New Drug (IND) application for YOLT-101, an in vivo base editing therapy targeting PCSK9 for the treatment of heterozygous familial hypercholesterolemia (HeFH). This marks YOLT-101’s second regulatory clearance-following FDA approval in June 2025-and establishes it as the first in vivo base editing therapy for cardiovascular disease to advance into clinical trials in both the U.S. and China."

New trial • Familial Hypercholesterolemia

YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH) (The Manila Times) - "YolTech Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for YOLT-101, an in vivo base editing therapy targeting PCSK9 for the treatment of heterozygous familial hypercholesterolemia (HeFH)."

IND • Familial Hypercholesterolemia • Heterozygous Familial Hypercholesterolemia

Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: RenJi Hospital | N=15 ➔ 20

Enrollment change • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders

Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH) (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: RenJi Hospital | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial primary completion date • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders

Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH) (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: First Affiliated Hospital Bengbu Medical College

New P1 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders

Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia (FH) (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: RenJi Hospital

New P1 trial • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Metabolic Disorders