Jiangsu Kanghe Biopharmaceutical Co., Ltd.

Phase Ib dose escalation phase Main objectives: a. To evaluate the safety and tolerability of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment; b. To determine the OBD (Optimal Biological Dose) of K1 injection combined therapy in Phase IIa. Secondary objectives: a. To evaluate the pharmacokinetic, pharmacodynamic and immunogenicity of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment; b. To preliminarily evaluate the preliminary efficacy of K1 injection combined with temozolomide and radiotherapy in patients with high-grade glioma who have failed standard treatment. Exploratory objectives: To explore the relationship between biomarkers (ASS1 expression) and anti-tumor activity. Phase IIa dose expansion phase Main objectives: To evaluate the preliminary efficacy of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma. Secondary objectives: a. To evaluate the safety and tolerability of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma; b. To evaluate the pharmacokinetic, pharmacodynamic and immunogenicity of K1 injection combined with temozolomide and radiotherapy in patients with newly diagnosed grade IV glioma. Exploratory objectives: To explore the relationship between biomarkers (ASS1 expression) and anti-tumor activity.

Primary objective: To evaluate the effectiveness of preoperative intravenous aprepitant injection in preventing postoperative nausea and vomiting in adults. Secondary objectives: 1) To evaluate the safety of preoperative intravenous aprepitant injection in preventing postoperative nausea and vomiting in adults; 2) To evaluate the pharmacokinetic characteristics of preoperative intravenous aprepitant injection in preventing postoperative nausea and vomiting in some subjects.

Primary objective: This study aims to study the pharmacokinetic characteristics of aprepitant injection (4.4ml:32mg) developed and produced by Jiangsu Kanghe Biopharmaceutical Co., Ltd. after a single intravenous injection under fasting conditions; using Heron Therapeutics, Inc's licensed aprepitant injection (Aponvie®, 32mg/4.4ml) as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and evaluate the human bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.