Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible forparticipation in this study:

1. Must have the ability to understand and sign a written informed consent form,which must be obtained prior to initiation of study screening.

2. Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test atscreening is required for female subjects of childbearing potential.

3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).

4. HBeAg-positive or HBeAg-negative chronic hepatitis B with all of the following:HBV DNA ≥ 2 x 104 IU/mL; Screening serum 1 ULN < ALT level ≤ 10 ULN.

5. Treatment-naive subjects (defined as < 12 weeks of oral antiviral treatmentwith any nucleoside or nucleotide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serumALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside ornucleotide analogue) will be eligible for enrollment. Treatment-experiencedsubjects receiving oral antiviral treatment at Screening must continue theirtreatment regimen until the time of randomization, when it will bediscontinued.

6. Any previous treatment with interferon (pegylated or non-pegylated) must haveended at least 6 months prior to the baseline visit.

7. Estimated creatinine clearance (CLcr) ≥ 50 mL/min（using the Cockcroft-Gaultmethod）based on serum creatinine and actual body weight as measured at thescreening evaluation, as follows:

（140-age in years）(body weight [kg]) (72)(serum creatinine [mg/dL]） 8) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant).

9. Must be willing and able to comply with all study requirements.

Exclusion Criteria:

• Subjects who meet any of the following exclusion criteria are not to be enrolled inthis study:

1. Pregnant women, women who are breastfeeding or who believe they may wish tobecome pregnant during the course of the study.

2. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.

3. Co-infection with HCV virus, HIV, or HDV.

4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).

5. Any history of, or current evidence of, clinical hepatic decompensation (e.g.ascites encephalopathy or variceal hemorrhage).

6. Abnormal hematological and biochemical parameters, including:

• Hemoglobin < 10 g/dl
• Absolute neutrophil count < 0.75 × 109/L
• Platelets ≤ 50 × 109/L
• AST or ALT > 10 × ULN
• Total Bilirubin > 2.5 × ULN
• Albumin < 3.0 g/dL
• INR > 1.5 × ULN (unless stable on anticoagulant regimen)

7. Received solid organ or bone marrow transplant.

8. Significant renal, cardiovascular, pulmonary, or neurological disease in theopinion of the investigator.

9. Significant bone disease (e.g. osteomalacia, chronic osteomyelitis,osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.

10. Malignancy within the 5 years prior to screening, with the exception ofspecific cancers that are cured by surgical resection (basal cell skin cancer,etc).

11. Currently receiving therapy with immunomodulators (e.g. corticosteroids),investigational agents, nephrotoxic agents, or agents capable of modifyingrenal excretion.

12. Known hypersensitivity to study drugs, metabolites, or formulation excipients.

13. Current alcohol or substance abuse judged by the investigator to potentiallyinterfere with participant compliance.

14. Any other clinical condition or prior therapy that, in the opinion of theInvestigator, would make the subject unsuitable for the study or unable tocomply with dosing requirements.

15. Subjects on prohibited concomitant medications. Subjects on prohibitedmedications, otherwise eligible, will need a wash out period of at least 30days.