Shandong Shenzhou Pharmaceutical Co. Ltd.

1. Primary objective: To evaluate the overall survival (OS) of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment. 2. Secondary objectives (1) To evaluate the progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to treatment failure (TTF), and patient-reported outcomes (PRO) of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment; (2) To evaluate the safety characteristics of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment; (3) To evaluate the immunogenicity characteristics of BC001 combined with paclitaxel versus placebo combined with paclitaxel in patients with gastric or GEJ adenocarcinoma who have failed first-line standard treatment. (4) To evaluate the PK characteristics of BC001 based on the population pharmacokinetic (PopPK) analysis method. (5) Explore the relationship between exposure and effect of BC001.

The absorption rate and extent of imidafenacin tablets and STAYBLA® were evaluated in healthy male and female subjects after meals to evaluate whether the two preparations are bioequivalent and safe for the test preparation imidafenacin tablets and the reference preparation STAYBLA® in healthy Chinese subjects.

The absorption rate and extent of imidafenacin tablets and STAYBLA® were evaluated in healthy male and female subjects under fasting conditions to evaluate whether the two preparations are bioequivalent and safe for the test preparation imidafenacin tablets and the reference preparation STAYBLA® in healthy Chinese subjects.