Foresee Pharmaceuticals Co., Ltd. announced the submission of a phase 3 Clinical Trial Application (CTA) for FP-001 42 mg in patients with central precocious puberty to EMA. Planned development stages: to conduct a phase 3 clinical trial and submit New Drug Application (NDA) to FDA and Marketing Authorisation Application (MAA) to EMA. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Foresee has submitted a phase 3 CTA (Clinical Trial Application) of FP-001 42 mg for the treatment of patients with central precocious puberty (CPP) to European Medicines Agency (EMA).

This phase 3 clinical trial is an open-label, single-arm, multinational, multicenter study. The population of enrollment will be pediatric patients aged 2 - 9 years with a diagnosis of CPP. Approximately 98 subjects will be enrolled from sites in the United States, Europe, China and Taiwan.

According to US FDA regulations, starting from August 19, 2022, Foresee may proceed with the phase 3 clinical trial for FP-001 42 mg in patients with CPP in the US. Please refer to the MOPS announcement made on August 22, 2022; the clinical trial is being initiated. GeneScience Pharmaceuticals has received a notification from NMPA on November 2, 2022, that the phase 3 clinical trial application in China for FP-001 42 mg in patients with CPP has been accepted for substantial review.

The clinical trial in China may begin if there are no negative opinions or questions raised by NMPA within 60 working days after the acceptance for substantial review. In addition, foresee has submitted a phase 3 IND for FP-001 42 mg in patients with CPP to Taiwan FDA on December 15, 2022. Please refer to the MOPS announcement made on the same day.

The IND application is currently under regulatory review. (E) Based on the clinical study design, patients will receive two injections of FP-001 42 mg at 6-month intervals: the first dose on day 0 and the second dose on week 24, and they will be monitored for up to 48 weeks to evaluate the efficacy, safety, and pharmacokinetics of FP-001 42 mg. The primary efficacy endpoint is the proportion of patients with serum Luteinizing Hormone (LH) concentrations < 4 mIU/mL at Week 24 in the intent-to-treat (ITT) population.