A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients

Inclusion Criteria: All patients must meet all the following criteria: * Must be informed of the investigational nature of this study and must provide written informed consent * Age ≥18 years, male or female * Non-muscle invasive transitional cell carcinoma of the bladder is histologically confirmed by Independent Pathology Review Committee (IPRC). Diagnosis and classification of intermediate-risk NMIBC is according to 2014 CUA Guideline of Diagnosis and Treatment of Urological Diseases in China: Low-risk: Primary, solitary, TaGl (PUNLMP, low-grade urothelial carcinoma), \<3cm, no CIS. (Note: the above conditions must be met at the same time as a low-risk NMIBC) Intermediate-risk: All tumours not defined in the two adjacent categories (between the category of low and high risk) High-risk: Any of the following: ① T1 tumour; ②G3(high-grade urothelial carcinoma) tumour;③carcinoma in situ (CIS); ④ Multiple, recurrent and large (\> 3 cm) TaG1G2(low-grade urothelial carcinoma) tumours (all features must be present) • No visible tumor after transurethral resection of bladder tumor (TURBT) on tumor lesion. Some requirements about Re-TURBT are as follows: It is recommended to conduct the secondary TURBT under following situations: incomplete first TURBT; no muscle tissue found in the first TURBT specimen, except Ta G1 (low grade) tumor and CIS only. The secondary TURBT is recommended 2-6 weeks, but better at 4 weeks, after the first TURBT. For subjects undergoing secondary TURBT…