Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition

Inclusion Criteria:

1. Male and female aged ≥ 14 years;

2. SBS patients dependent on PN/IV support for at least 6 consecutive months due tomajor intestinal resection;

3. At least 3 PN/IV support sessions per week are required 1 week before screening or 2weeks before baseline;

4. Be on stable PN/IV support for at least 4 consecutive weeks before administration;

5. For subjects with a history of Crohn's disease (CD), clinical assessment ofremission for at least 12 weeks prior to administration;

6. Be able to understand and provide signed informed consent, for those under 18 yearsold, the guardian should also sign the informed consent;

7. Be able to complete experiments in accordance with the protocol.

Exclusion Criteria:

1. Have used teduglutide in the past or may be allergic to teduglutide or itscomponents;

2. Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6months before screening;

3. Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitorswithin 30 days before screening;

4. With active Crohn's disease or those who need to change biological therapy within 6months before screening;

5. With active inflammatory bowel disease (IBD) or IBD patients who have receivedimmunosuppressant therapy changes in the past 3 months;

6. With unstable absorption due to cystic fibrosis, untreated megacolon disease orknown DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);

7. With clinically obvious intestinal obstruction or active stenosis within 6 monthsbefore screening;

8. Have undergone major gastrointestinal surgical intervention within 3 months beforescreening, such as continuous transverse enteroplasty or other intestinallengthening surgery (esophageal intubation or endoscopic surgery is allowed);

9. Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular,respiratory, renal, infectious, endocrine, liver or central nervous system diseases,etc.);

10. Have malignant tumors within 5 years before screening (except for fully treatedcervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin,localized prostate cancer after radical surgery, and breast ductal carcinoma in situafter radical surgery);

11. With severe liver function impairment:

12. Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients withGilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;

13. Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 ×ULN;

14. With renal function impairment:

15. Serum creatinine ≥2.0 × ULN;

16. Creatinine clearance < 60 ml/min (calculated according to the Cockcroft-Gaultformula, see Appendix 3 for details);

17. Pancreatic abnormalities:

18. Serum amylase ≥ 2.0 × ULN;

19. Serum lipase ≥ 2.0 × ULN;

20. More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinalobstruction, severe water and electrolyte disorders) within 12 months beforescreening;

21. Unplanned hospitalization within 30 days before screening;

22. Pregnant or lactating women, women or men who have fertility plans or do not agreeto take effective contraceptive measures during the trial;

23. Participated in any clinical trial (excluding antibody treatment-related clinicaltrials) within 30 days before screening or participated in any antibodytreatment-related clinical trials within 3 months before screening;

24. Other condition the investigator believes would be unsuitable for participation inthis clinical study.