HRS-5635 / Jiangsu Hengrui Pharma - LARVOL DELTA

A PHASE 1 STUDY OF THE SIRNA HRS-5635 IN HEALTHY SUBJECTS AND PATIENTS WITH CHRONIC HEPATITIS B (AASLD 2025) - P1 | "HRS-5635 at the tested doses were tolerated, showed favorable safety and pharmacokinetic profiles, and demonstrated preliminary evidence of antiviral activity through HBsAg reduction, supporting further clinical development of HRS-5635 for treating CHB."

Clinical • P1 data • Endocrine Disorders • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Metabolic Disorders • Respiratory Diseases

Jiangsu Hengrui Pharmaceuticals…announced that its next‑generation small‑interfering RNA (siRNA) drug, HRS‑5635 injection, has been proposed for inclusion in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) (flcube.com)

Breakthrough therapy • Hepatitis B • Infectious Disease

HRS-5635-201: A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=303 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | N=165 ➔ 303 | Trial completion date: Sep 2026 ➔ Jan 2027 | Trial primary completion date: May 2026 ➔ Aug 2026

Enrollment change • Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

HRS-5635-201: A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=165 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation