This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of HRS-5635 injection as compared to the placebo arm in nucleos(t)ide analogue-suppressed HBeAg-negative patients with chronic hepatitis B. The total duration of the study, including screening (up to 4 weeks), the double-blind treatment stage (60 weeks)，NAs-only treatment stage（12 weeks） and the off-treatment follow-up (24 weeks), is up to approximately 100 weeks at maximum for each participant.
Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
HBeAg negative at screening;
On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
With autoimmune disease;
History of solid organ transplantation or hematopoietic stem cell transplantation;
Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
Parallel
HRS-5635 Injection
DrugHRS-5635 Injection, administered by subcutaneous injection;
Placebo
DrugPlacebo, administered by subcutaneous injection.
Percentage of participants with sustained HBV DNA suppression and HBsAg loss within 24 weeks after discontinuation of all HBV therapy
Percentage of participants with sustained HBV DNA suppression and HBsAg < 100 IU/mL
Percentage of participants with sustained HBV DNA suppression and HBsAg < 10 IU/mL
Percentage of participants with sustained HBV DNA suppression
Percentage of participants with HBsAg < 100 IU/mL
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