Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease

Inclusion Criteria:

1. Those who have been diagnosed with Fabry disease by genetic and alpha-galactosidaseA enzyme tests and grouped by sex are as follows:

• Male: Those who have confirmed GLA mutation (variation of α-galactosidase Agene) by genetic testing, and whose activity of alpha-galactosidase A inleukocytes is 5% or less than the normal mean value

• Female: Those who have confirmed GLA mutation by genetic testing, and whosealpha-galactosidase A is within the normal range or is deficient

2. Age: Those who are aged 8 years or older

3. Those who have at least one of the following symptoms and signs:

• Glomerular filtration rate decreased (Inclusion criteria: 2 or more cases of 30 ≦ eGFR < 90 mL/min/1.73 m2 [adjusted for age >40] [including results within 6months of the screening visit, but including results within 12 months forpatients with a 60 ≦ eGFR < 90 mL/min/1.73 m2])
• Proteinuria that is equivalent to microalbuminuria or worse (Inclusioncriteria: 2 or more cases of creatinine 30 mg/g in random urine at least 24 hours apart [including results within 6 months of the screening visit]or ≥30 mg of albuminuria in 24-hour urine)
• For 24 hr urinary protein extraction (>4 mg/m2/hr) or for spoturinary protein/creatinine ratio (≥200 mg/g [Cr]) *Pediatrics: Aged <19 years
• Abnormal left ventricular function as evidenced by MRI orechocardiography
• Left ventricular mass index (LVMI)* >115 g/m2 (male), >95g/m2 (female) or
• Left ventricular wall thickness >12 mm (However, in thecase of patients with hypertension, patients must haveblood pressure treatment for at least 6 months prior toadministration of the same drug) etc.
• Clinically significant arrhythmias and conductiondisturbances, etc.
• Stroke or transient ischemic attack, etc., asevidenced by objective testing

4. Patients who have not previously received enzyme replacement therapy (ERT) orChaperone therapy for treatment of Fabry disease

5. Patients who voluntarily consented and signed the informed consent form

6. Patients (female patients and partners of male patients who are of childbearingpotential) who have agreed to use a medically appropriate method of contraception (intrauterine device, condoms, surgical methods such as vasectomy) during theclinical study

Exclusion Criteria:

1. Patients who participated in other studies in which investigational products areadministered within 30 days prior to the screening visit

2. Patients with chronic kidney disease stage 4 to 5 (CKD 4-5; see Section 16.1)

3. Patients who are currently on dialysis or have a history of kidney transplantation,or patients scheduled for dialysis at the time of screening, or waitlisted forkidney transplantation

4. Patients who have started angiotensin-converting enzyme inhibitor (ACEi) orangiotensin receptor blocker (ARB) treatment within 4 weeks prior to the screeningvisit or whose dose has been changed

5. Patients who are pregnant, breastfeeding, or planning to become pregnant orbreastfeed during the clinical study

6. Patients with a history of HIV, hepatitis B/C or HIV antibodies, hepatitis B surfaceantigens, or hepatitis C antibodies

7. Patient whose medical, emotional, behavioral, or psychological conditions appear tointerfere with compliance with the requirements of the clinical study according tothe investigator's judgment