A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD

Inclusion Criteria:

• Before the treatment, the subject should be diagnosed as AGHD based on medicalhistory, clinical symptoms, vital signs, insulin tolerance test and imagologicalexaminations.

• The subject is diagnosed as GHD during childhood and remains as GHD in adulthood,and the linear growth has completed: bone age (BA) ≥18 years old; or the AGHDpatient who experiences paroxysm after 18 years old: such as patients who haveexperienced pituitary surgeries (2 years after pituitary adenoma surgery, 5 yearsafter craniopharyngioma surgery and 12 months after other pituitary surgeries),traumatic brain injury (TBI), Sheehan syndrome, and etc..

• The plasma GH concentration peak is <5ng/ml in insulin tolerance test (ITT) (it'sunnecessary to conduct ITT in the following conditions: anterior pituitarydysfunction, pituitary hormone deficiency (more than 3 hormones) and serum IGF-1level below lower limit of normal value: i.e. -2 SD).

• Age: 18-60 years old.

• Patients with no history of GH treatment for more than one year.

• Body mass index (BMI): 18.5 kg/m2≤BMI≤30kg/m2.

• When there is other hormones deficiency (such as glucocorticoids, thyroid hormones andsex steroids), the subject should have received other hormone replacement therapiesand the therapeutic dose shall be stable within 3 months before the enrolment.

• The subject agrees to cooperate and complete the concerted trial procedures such asfollow-ups, treatment plan and laboratory examinations, and sign the written informedconsent.

Exclusion Criteria:

• Patients with serious heart diseases, including NYHA III or above, serious arrhythmia,unstable angina pectoris or myocardial infarction within the latest 6 months.

• Patients with a history of ischemic cerebrovascular disease, febrile convulsion andepilepsy seizures.

• Patients with carpal tunnel syndrome.

• Patients with poor hypertension control (systolic pressure>140mmHg or diastolicpressure >90mmHg under treatment).

• Patients with previous or present history of malignant tumor: two or more directrelatives within three generations have previous or present history of tumor.

• Patients undergoing anti-depressive therapy, immunosuppressive therapy, chemotherapyand radiotherapy (or with a history of radiotherapy).

• Patients who have ever taken antiobesity drug within the latest 3 months.

• Patients with serious infection.

• Patients with consciousness disorders and mental diseases.

• Subjects with impaired glucose regulation (IGR) (impaired fasting glucose (IFG) and/orimpaired glucose tolerance (IGT) ) or diabetes; patients with a family history ofdiabetes (direct relatives).

• Subjects with abnormal liver and kidney functions (ALT > 2 times of upper limit ofnormal value; eGFR calculated by MDRD formula <60).

• Subjects positive for anti-HBc, HBsAg or HBeAg in Hepatitis B virus tests.

• Subjects with highly allergic constitution or allergy to proteins or investigationalproductorits excipient in this study.

• Subjects who took part in other clinical trials within 3 months.

• Patients with other mental or physical deficiencies that influence the evaluation ofinvestigational product.

• Pregnant or lactating women; females planning to get pregnant within one year.

• Subjects whose tumor markers exceed the upper limit of normal range and there-examination result is still high.

• Other conditions which is unsuitable for the study in the opinion of the investigator.