Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients

Exclusion Criteria

• •1. Concurrent unstable or uncontrolled medical conditions which include either one of the followings:
• •* Active systemic infections that necessitate antimicrobial therapy;
• •* Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
• •* Acute myocardial infarction within 12 months OR clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association \[NYHA\]);
• •* Uncontrolled diabetes (HbA1c \> 9.5% in past three months) or poor compliance with hypoglycemic agents;
• •* The presence of chronically unhealed wound or ulcers;
• •* Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the subject or the integrity of study.
• •2. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Subjects with a previous malignancy without history of liver involvement and without evidence of disease for ≥ 3 years can participate).
• •3. Pregnancy (confirmed by urine beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding.
• •4. History of human immunodeficiency virus infection (HIV). All subjects must agree to undergone screening for HIV.
• •5. Subject who has an active or a documented history of autoimmune disease (must be confirmed by negative antinuclear antibodies (ANA), rheumatic factor (RF) and anti-double stranded DNA level (anti-dsDNA)).
• •6. Subject who currently has hepatitis C (defined as anti-HCV antibody reactive or detectable HCV RNA \> 15 IU/L) or hepatitis D (defined as anti-HDV antibody reactive).
• •7. Subject who has a history of interstitial lung disease.
• •8. Have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of autoimmune disease.
• •9. The subject is the investigator, sub-investigator or any one directly involved in the conduct of the study.
• •10. Subject has a history or current evidence of any condition or disease that could confound the results of the study or is not the best interest of the subject to participate, in the opinion of Investigator.
• •11. History of alcoholism OR recreational drug use.
• •12. Preexisting advanced liver disease and cirrhosis subject: advanced hepatic fibrosis and cirrhosis are defined as Fibroscan ≥ 9.5 Kpa or Acoustic radiation force impulse (ARFI) ≥ 1.81 m/sec or Fibrosis-4 (FIB-4) ≥ 3.25 or METAVIR F ≥ 3.