Nona Biosciences Suzhou Co. Ltd.

Adverse events and abnormal laboratory indicators during treatment were observed to evaluate the medium- and long-term safety of HBM9161 combined with basic treatment in gMG patients. Improvement of signs and symptoms during treatment was observed to evaluate the medium- and long-term effectiveness of the study drug HBM9161 combined with basic MG treatment.

Part 1: Dose escalation part, to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of HBM4003 combined with toripalimab in patients with advanced hepatocellular carcinoma and other solid tumors Part 2: Dose expansion part, to evaluate the preliminary efficacy and safety of HBM4003 combined with toripalimab at the RP2D dose in patients with advanced hepatocellular carcinoma

Primary objective: To preliminarily evaluate the efficacy of HBM9161 680 mg subcutaneous injection weekly and weekly followed by alternate weeks for 12 weeks in Chinese patients with active, moderate to severe TED; Secondary objective: To preliminarily evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and compliance of subjects with the study regimen of HBM9161 subcutaneously injected for 12 weeks in Chinese patients with TED.