GenSci120 / GeneScience - LARVOL DELTA

GenSci120, a novel PD-1 Agonist, Demonstrated Favorable Safety and PK/PD Profiles in a First-in-Human Single-Ascending-Dose Phase 1 Study in Healthy Adults (EULAR 2026) - "Conclusions GenSci120 demonstrated a favorable safety, pharmacokinetic, and pharmacodynamic profile in healthy subjects. These findings provide proof of mechanism in humans and support further clinical development of GenSci120, including multiple-ascending-dose studies and subsequent evaluation in patients with autoimmune diseases."

Clinical • First-in-human • P1 data • PK/PD data • Immunology • Infectious Disease • Respiratory Diseases • PD-1 • PD-L1 • PD-L2

Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD (clinicaltrials.gov) - P2 | N=450 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD (clinicaltrials.gov) - P2 | N=450 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Dual agonism and selective T-cell depletion activity of a PD-1-directed antibody for treating autoimmune diseases. (PubMed, MAbs) - P1 | "In a first-in-human study in healthy adults (NCT06827457), GenSci120 demonstrated favorable safety/tolerability and pharmacokinetic profiles as well as robust pharmacodynamic effect. Together, these findings suggest the potential of GenSci120 as an innovative precision medicine for treating autoimmune diseases and support further evaluation of this investigational new drug in future clinical trials."

First-in-human • Journal • Immunology • PD-L1

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults. (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Dec 2025

Trial completion • Trial completion date • Immunology

Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China. (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China. (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults. (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults. (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Immunology • PD-1