A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD

Inclusion Criteria:

1. Capable to understand and sign the informed consent form (ICF) which includescompliance with the requirements and restrictions listed in the ICF and in thisprotocol.

2. Women or men aged ≥50 years when signing the ICF.

3. In the Investigator's judgment, willing and able to complete all visits andassessments adhering to the prohibitions and restrictions specified in thisprotocol.

4. Newly diagnosed, untreated, active CNV lesions secondary to age-related maculardegeneration that affect the central subfield (CSF) in the study eye. Active CNV wasdefined as leakage on fluorescein angiography (FA) and subretinal or intraretinalfluid on optical coherence tomography (OCT) with confirmation of the reading centerduring screening.

5. The total lesion area (including hemorrhage, scar and neovascularization) of thestudy eye ≤12 disc area (DA) with confirmation of the reading center beforerandomization

6. The BCVA letters between 24 and 73, inclusive, in the study eye, using EarlyTreatment Diabetic Retinopathy Study (ETDRS) charts.

7. Participants' fellow (non-study) eye must have a BCVA of 24 letters or better.

8. Clear ocular media and adequate pupillary dilatation to allow acquisition of goodquality retinal images to confirm the diagnosis.

Exclusion Criteria:

1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis oratrophy involving the fovea, or CNV due to other causes in the study eye (e.g.,ocular histoplasmosis, trauma,pathological myopia, etc.) with confirmation of thereading center.

2. The fellow (non-study) eye needs anti-VEGF IVT injection (e.g. CNV due to wAMD,trauma, pathological myopia, retina vein occlusion, diabetic macular edema, etc.) inthe next 3 months after randomization, in the investigator's judgment.

3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens (exceptyttrium-aluminium-garnet (YAG) laser posterior capsulotomy after intraocular lensimplantation ≥30 days prior to first dose) in the study eye.

4. Active or recent (within 1 month prior to dose 1) intraocular, extraocular orperiocular infection (including conjunctivitis, keratitis, scleritis orendophthalmitis), or history of idiopathic or autoimmune-associated uveitis ineither eye.

5. Vitreous hemorrhage in the study eye within 3 months prior to dose 1.

6. Corneal dystrophy or history of corneal transplantation, scleral softening orhistory of scleral softening, history of rhegmatogenous retinal detachment ormacular hole (Stage II, III or IV) in the study eye.

7. Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] ≥25mmHg despite treatment with antiglaucoma medication), and/or glaucoma filteringsurgery (e.g., trabeculectomy, scleral nipping, non-penetrating trabeculectomy,etc.)

8. Equivalent spherical diopter of the study eye ≥-8D. For participants who hadundergone refractive correction or cataract surgery, the equivalent sphericaldiopter of the study eye before surgery ≥-8D.

9. Estimated by the Investigator, any concurrent intraocular condition except wAMD (e.g., diabetic retinopathy, dry AMD, retina vein occlusion, uveitis, angioidstreaks, retinal detachment, epiretinal membrane, amblyopia, central serouschorioretinopathy, etc.) in the study eye that limited the potential to gain visualacuity upon treatment with the investigational product, or could have requiredmedical or surgical intervention during the study to prevent or treat visual loss.

10. Underwent intraocular surgery including verteporfin photodynamic therapy (PDT),transpupillary thermotherapy, macular translocation, vitrectomy, laserphotocoagulation in macular area, other surgery in macular area or surgery to treatAMD.

11. Previous extraocular or periocular surgery within 1 month or intraocular surgery (except the surgery mentioned in exclusion 10 ,such as cataract surgery, etc.)within 3 months prior to dose 1, or current unhealed wound, moderate or severe ulceror fracture in the study eye.

12. Subconjunctival or intraocular use of corticosteroids within 3 months (includingsubconjunctival or intraocular long-acting implant within 6 months) prior to dose 1in the study eye. Use of systemic corticosteroids for 30 or more consecutive dayswithin 3 months prior to dose 1. Inhaled, nasal or dermal steroids are permitted.Topical ocular corticosteroids administered for 30 or more consecutive days in thestudy eye within 3 months prior to dose 1.

13. Previous systemic anti-VEGF therapy or IVT injection of any anti-VEGF drug intoeither eye or other ocular use of anti-VEGF drug within 3 months prior to dose 1.

14. Participated in any drug (other than vitamins and minerals) or device clinicaltrials 3 months or the duration of 5 half-lives of the study drug (which is longer)before the first dose and have used the test drug or received device treatment.

15. Pregnancy or lactation, or fertile men or women not willing to use effectivecontraception from the day when ICF was signed to at least 6 months following thelast dose of study intervention.

16. Infertile women or men fail to meet either of the following ones: 1) menopause (≥12continuous months of amenorrhea with no identified cause other than menopause beforescreening); 2) surgically sterilized. Fertile women or men fail to meet either of the following ones: 1) women ofchildbearing potential must have a negative urine or serum pregnancy test resultwithin 14 days prior to initiation of the study intervention, and should notbreastfeed. If the urine pregnancy test is positive, it must be confirmed by a serumpregnancy test; 2) agreement to remain abstinent (refrain from heterosexualintercourse) or use effective contraceptive methods from signed ICF to at least 6months following the last dose of study intervention. Effective contraceptivemethods with a failure rate of <1% per year, including bilateral tubal ligation,male sterilization, established, proper use of hormonal contraceptives that inhibitovulation, hormone releasing intrauterine devices (IUDs), and copper IUDs.

17. In the Investigator's judgment, there is evidence of a disease or condition thatcontraindicates the use an investigational drug or that might affect interpretationof the results of the study or render the participant at high risk for treatmentcomplications (e.g. stroke or myocardial infarction within 6 months prior to dose 1,uncontrolled hypertension (systolic blood pressure ≥160 mmHg, or diastolic bloodpressure ≥100 mmHg), etc.).

18. Uncontrolled diabetes (defined as HbA1c>10.0%).

19. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more thantwice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times morethan the ULN, and is clinically significant in the opinion of the Investigator.

20. Abnormal coagulation function: prothrombin time(PT) or International normalizedratio (INR) ≥ 1.5 ×ULN, or activated partial thromboplastin time (aPTT) ≥1.5 ×ULN,and is clinically significant in the opinion of the Investigator.

21. Active disseminated intravascular coagulation and obvious bleeding tendency within 3months prior to dose 1.

22. Evidence of significant uncontrolled concomitant diseases such as cardiovasculardiseases, nervous system diseases, respiratory system diseases, urinary systemdiseases, digestive system diseases and endocrine diseases (e.g., stroke, myocardialinfarction).

23. Current treatment for active systemic infection, or history of recurrent seriousinfections.

24. Known active or suspected autoimmune diseases, requiring systemic immunosuppressivetherapy.

25. Positive for syphilis screening test human immunodeficiency virus (HIV) infection orpositive for HIV screening test.

26. Known allergy to any component of the study intervention or history of allergy tofluorescein or indocyanine green, any anesthetics or antimicrobial agents usedduring the course of the study.

27. In the Investigator's judgment, other conditions considered not amenable to thisstudy.

28. Participant who has been diagnosed to be COVID-19 within 2weeks prior to the firstdose, or still symptomatic from an earlier infection (except symptoms associatedwith "Long COVID "), or displaying symptoms consistent with COVID-19 in the absenceof a confirmed Covid-19 infection.