⁃ Participants are eligible for the study only if all of the following inclusion criteria are met:

• Aged ≥ 6 to \<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), including adolescents aged ≥ 12 to\<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), and children aged ≥ 6 to\<12 years at the time of signing the ICF;

• Male or female;

• Participants diagnosed with ASD according to the ASD diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Schedule for Affective Disorders and Schizophrenia for School Aged Children Present and Lifetime version (K-SADS-PL), DSM-5 ASD module;

• Child Autism Rating Scale 2-ST (CARS 2-ST) raw score ≥36;

• CGI-S score ≥4;

• Participants and their legal guardians understand and are willing to participate in this trial, with ICF signed by the legal guardian and participants aged ≥ 8 years; for participants who, at the discretion of the investigator, have cognitive deficits that prevent them from signing the ICF, their legal guardians sign the ICF on behalf of them;

• Females of childbearing potential (as defined in Appendix 15.1) agree to remain abstinent or use a reliable method of contraception for the duration of the trial and until 3 months after the last dose of the investigational product.