[Major News] Hengrui's Phase III Clinical Trial | Recruiting Adolescent and Adult Patients with

Study Drug:SHR-1918 Injection

SHR-1918 is an angiopoietin-like protein 3 (ANGPTL3) monoclonal antibody independently developed by Hengrui Pharmaceuticals. It reduces serum triglyceride (TG) and LDL-C levels by inhibiting the activity of ANGPTL3.

Target Enrollment Number:This study will be conducted simultaneously in multiple hospitals across China,with a plan to recruit at least 45 HoFH patients.This study has currently been approved by the ethics committees of each trial hospital, and patient recruitment is now open to the public.

Recruitment Subjects (Main Inclusion Criteria):

1. Age must be ≥12 years on the date of signing the informed consent form;

2. Genetically diagnosed or clinically diagnosed with homozygous familial hypercholesterolemia;

a) Genetic testing confirms 2 allelic mutations at the gene loci of low-density lipoprotein receptor (LDLR), ApoB, PCSK9, or LDLRAP1;

or b) Previously untreated blood LDL-C >13 mmol/L, or post-treatment LDL-C >8 mmol/L, accompanied by 1) cutaneous or tendon xanthomas occurring before 10 years of age, and/or 2) elevated untreated LDL-C levels in both parents, all consistent with the diagnostic criteria for heterozygous familial hypercholesterolemia;

3. Fasting triglycerides ≤5.6 mmol/L at screening;

4. Body weight ≥40 kg at screening;

5. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form;

The following conditions are outside the scope of this trial (Main Exclusion Criteria):

1. Known allergy to the investigational drug or any component of the investigational drug, or a history of severe allergic reactions to other antibody drugs;

2. Use of SHR-1918 or other ANGPTL3 inhibitors within 6 months prior to screening;

3. Treatment with lomitapide or mipomersen within 5 months prior to screening;

4. LDL plasma exchange therapy within 8 weeks prior to screening;

5. Previous liver transplantation surgery;

6. Diagnosed with sitosterolemia;

7. Presence of Class III-IV heart failure as defined by the New York Heart Association (NYHA) at screening;

Note: The above are some of the main criteria. The final inclusion criteria will be assessed by the study physician and will be based on the subject's comprehensive examination results.