Foresee Pharmaceuticals Co., Ltd. announced that the application of a phase 3 IND for FP-001 42 mg in patients with central precocious puberty has been approved by China NMPA. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): GeneScience Pharmaceuticals, Foresee's licensing partner in China, has submitted a phase 3 IND (Investigational New Drug) application for FP-001 42 mg to China NMPA (National Medical Products Administration) for the treatment of patients with central precocious puberty on October 19, 2022. GeneScience Pharmaceuticals has received a notification from NMPA for substantial review on the application on November 2, 2022.

Foresee has received notification from GeneScience that it has received the approval from NMPA that the phase 3 clinical trial can be proceeded. 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.

Foresee has submitted a phase 3 IND application of FP-001 42 mg for the treatment of patients with central precocious puberty to Taiwan FDA on December 15, 2022. Foresee has received the approval letter from Taiwan FDA on December 30, 2022, the phase 3 clinical trial can be proceeded; the clinical trial is being initiated. In addition, Foresee has submitted a phase 3 CTA (Clinical Trial Application) for FP-001 42 mg in patients with CPP to EMA on December 23, 2022, this CTA is currently under regulatory review.

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. Upcoming development plan: Estimated date of completion: The clinical trial is expected to complete in 2025.

Time of completion is determined by actual condition of recruitment. Market situation: gonadal axis” was activated prematurely, causing children to enter puberty prematurely, between 2 years and 9 years of age. While puberty normally starts between ages 8 and 13 in girls and between ages 9 and 14 in boys, patients with central precocious puberty begin exhibiting signs before puberty.

The development of secondary sexual characteristics begins, such as girls developing breasts and beginning their menstrual periods; boys have growth of genitalia and deepening of the voice. It is estimated that CPP occurs in 1 out of every 5,000 to 10,000 children. CPP is more common in girls than in boys, with a female to male ratio of around 20: 1.