Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)

Inclusion Criteria:

• Patients must be experiencing an acute GPP flare of moderate-to-severe intensity atbaseline, defined as:

1. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of ≥ 3;

2. New appearance or worsening of existing pustules, and a GPPGA pustulationsubscore of ≥ 2;

3. ≥ 5% Body Surface Area (BSA) covered with pustules.

• Men and women of reproductive age who have no parenting plans and are willing to usereliable contraception during the study period and for 6 months after the last doseof the study drug;

• Patients who fully understand and voluntarily sign an ICF, and are willing and ableto follow clinical study and subsequent visit schedules.

Exclusion Criteria:

• Drug-triggered acute generalized exanthematous pustulosis (AGEP);

• Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);

• Other active inflammatory or autoimmune diseases requiring systemic treatment withimmunosuppressants, including but not limited to rheumatoid arthritis (RA),psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory boweldisease, and uveitis.

• Patients with an increased risk of infectious complications as assessed by theinvestigator (e.g., a recent suppurative infection, any congenital or acquiredimmunodeficiency, such as HIV infection, prior organ or stem cell transplantation);

• Patients who have received a live vaccine or investigational live vaccine within 6weeks prior to the first dose of the study drug, or plan to receive a live vaccineor participate in a clinical study of investigational live vaccine during the studyperiod or within 6 weeks after completion of administration of the study drug;

• Patients who have had a serious trauma or undergone a major surgery within 1 monthprior to the first dose of the study drug, or plan to undergo any elective surgeryduring the study period;

• Patients with documented active or suspected malignancy or a history of malignancywithin 5 years prior to screening;

• Patients with a history of severe allergy, who have experienced grade 3-4 allergicreactions when receiving other monoclonal antibodies, or those who are known to havehypersensitivity to protein drugs, recombinant proteins, or HB0034 components;

• Subjects who are pregnant or breastfeeding, or those who have a positive pregnancytest result. Breastfeeding female subjects who stop breastfeeding prior to the firstdose of the study drug until 16 weeks after the end of the trial will not beexcluded;

• Patients who are currently participating in clinical trials or have participated inclinical trials of any drug/device within 30 days (or 5 half-lives, whichever islonger) prior to the first dose of the study drug;

• Patients expected to have poor compliance, such as those who are uncooperative, failto receive follow-up on time, and are unlikely to complete the study;

• Other reasons that the investigator considers it is inappropriate to participate inthe study.