FAREVA PAU

To evaluate the efficacy of FP-001 42mg for the treatment of children with central precocious puberty (CPP). To evaluate the safety and tolerability of FP-001 42mg in children with CPP. To evaluate the peak concentration characteristics of FP-001 42mg after the first dose. To evaluate the PD relationship. To evaluate the changes in growth rate and bone age progression compared with baseline in children treated for 48 weeks after the first injection. To evaluate the changes in physiological signs of puberty in children. To evaluate whether FP-001 42mg can continue to suppress serum LH concentrations to <4 mIU/mL during the dosing interval (6 months). To evaluate the "acute-on-chronic" (AOC) response 48 hours after the second dose.

The efficacy of leuprorelin emulsion injection in the treatment of premenopausal breast cancer was evaluated using the inhibition rate of serum E2 concentration maintained at postmenopausal levels (≤ 30 pg/mL) from the 4th to 48th week after administration as a surrogate indicator for efficacy evaluation.

Main purposes: 1) Using serum testosterone as a surrogate index for effectiveness evaluation and 50 ng/dL as the castration limit, evaluate the effectiveness of leuprolide injection emulsion from the end of 28 days after the first dose to the second dose. Castration maintenance rate at the end of 168 days after treatment. 2) To evaluate the safety and tolerability of leuprolide injection emulsion administered as two subcutaneous injections in patients with advanced prostate cancer. Secondary objectives: 1) Using 20 ng/dL as the significant castration limit, evaluate the efficacy of leuprolide emulsion for injection from the end of 28 days after the first dose to the end of 168 days after the second dose. Significant castration maintenance rate. 2) To evaluate the effect of twice-administered leuprolide emulsion injection on serum prostate-specific antigen (PSA). 3) To evaluate the effect of twice-administered leuprolide emulsion injection on luteinizing hormone (LH). 4) Evaluate the castration escape phenomenon that occurs during the administration of leuprorelin injection emulsion, including the fluctuation of testosterone levels caused by the second administration (slow-quick phenomenon). 5) Evaluate the pharmacokinetic (PK) characteristics of leuprolide injection emulsion administered twice.