Zhuhai Beihai Biotechnology Co., Ltd.

The study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II).

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.

The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the preliminary efficacy.