Hengrui's Class 1 New Drug HRS-5635 Enters Phase III Clinical Trial Targeting Functional Cure of Chronic Hepatitis B

On May 26, the ClinicalTrials website indicated that Hengrui Pharma has registered a Phase III clinical trial in China for HRS-5635 to evaluate the HRS-5635 injection in patients receiving nucleos(t)ide analogue suppression...HBeAg-negative chronic hepatitis B patientsefficacy and safety in.

Source:ClinicalTrials Official Website

Chronic hepatitis B is caused by hepatitis B virus（HBV）A chronic inflammatory liver disease caused by persistent infection, which is also a major cause of liver cirrhosis and primary hepatocellular carcinoma.Functional cure, as the ideal treatment goal for chronic hepatitis B, aims to achieve hepatitis B surface antigen (HBsAg) clearance following a finite course of treatment.（HBsAg）. Current therapies include nucleos(t)ide analogues（NAs）and pegylated interferon alfa（Peg-IFNα）Its efficacy in HBsAg clearance is limited, making functional cure difficult to achieve, and there is an urgent need to develop more effective products or treatment regimens.

HRS-5635 injection is independently developed by Hengrui Pharma.Next-Generation Liver-Targeted HBV siRNA Drug. In September 2025, HRS-5635 was granted Breakthrough Therapy designation by the CDE for the treatment of chronic hepatitis B.

Results from the Phase II clinical study of HRS-5635 monotherapy for chronic hepatitis B demonstrate that HRS-5635 has the potential to improve functional cure rates in chronic hepatitis B, while also exhibiting a favorable safety profile.

A multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical trial has been initiated to evaluate the efficacy and safety of HRS-5635 injection in HBeAg-negative chronic hepatitis B patients receiving nucleos(t)ide analogue suppression. The total duration of the study(including a screening period [up to 4 weeks], a double-blind treatment period [60 weeks], and a post-treatment follow-up period [24 weeks])Up to approximately 88 weeks.

Screenshot source: Insight Database

Oligonucleotide therapy has emerged as a highly competitive therapeutic area in research for the clinical cure of hepatitis B. According to the Insight database, there are currently 17 oligonucleotide drugs worldwide undergoing clinical trials for hepatitis B. Among them, the most advanced is GSK's Bepirovirsen.(Bepirovirsen), has already been filed for marketing approval. Haibo's AHB-137, Hengrui Pharma's HRS-5635Regarding progress, Phase III clinical trials are underway.

Insight Database Compiles Monthly List of New Drugs Entering Global Phase III Clinical Trials for the First Time in 2026，Scan the QR code below ?, reply with the keywordNew Drug Phase III Clinical TrialAvailable for free(Updated once at the beginning of each month, current as of April)。

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Editor: Xin Yao

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