Xiajiang Hemei Pharmaceutical Co., Ltd.

The main purpose of the study is to evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the progression-free survival (PFS) assessed by IRC. The key secondary purpose is to evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the OS of the subjects. Other secondary purposes are to further evaluate the effectiveness of Hemay022 combined with AI in the treatment of patients with ER-positive and HER2-positive advanced breast cancer based on the PFS, ORR, DCR, DOR and other indicators assessed by the investigators.

Primary purpose: To evaluate the effect of food on the pharmacokinetic characteristics of Hemay022 tablets by taking a single dose of Hemay022 tablets on an empty stomach and after a meal in healthy subjects, and to provide a reference for the formulation of clinical dosing regimens. Secondary purpose: To observe the safety of a single oral dose of Hemay022 tablets on an empty stomach and after a meal; to scan and identify the metabolites of Hemay022 tablets in the human body.

Primary objective: To explore the efficacy and dose-effect relationship of Hemay007 at different dosing regimens for active ulcerative colitis compared with placebo. Secondary objective: To evaluate the safety of Hemay007 at different dosing regimens for active ulcerative colitis compared with placebo. To observe the population pharmacokinetic characteristics of Hemay007 in patients with ulcerative colitis.