GeneScience Pharmaceuticals Co., Ltd. announced that it has submitted a phase 3 IND (Investigational New Drug) application to China NMPA (National Medical Products Administration) of FP-001 42 mg for the treatment of patients with premenopausal breast cancer with HR-positive (ER+ and/or PR+) /her2 negative with mild to moderate lymph node involvement on a top of standard of care Tamoxifen. This phase 3 clinical trial is an open-label, randomized, multicenter, parallel-group comparative study in China. The population of enrollment will be patients aged 18-59 years with a diagnosis of premenopausal breast cancer.

Approximately 220 subjects will be enrolled from sites in mainland China, 110 subjects for the experimental group and control group, respectively. Based on the clinical study design, all eligible subjects will be randomized into treatment groups in a 1:1 ratio, with the experimental group receiving two injections of FP-001 42 mg at 6-month intervals: the first dose on day 0 and the second dose on week 24; the control group receives 11.25 mg of Leuprorelin Acetate (Lupron), subcutaneously every 12 weeks, administered continuously for 4 times. Both the treatment groups will be monitored for up to 48 weeks to evaluate the efficacy, safety, and pharmacokinetics.

The primary efficacy endpoint is the cumulative probability of maintaining serum estradiol (E2) to the menopausal level (30 pg/mL) from Week 4 through Week 48. If not approved by the competent authority, or should the interim analysis or the clinical trial not reach statistical significance, the risks and the associated measures the Company may occur: N/A (3) After obtaining official approval or the results of interim analysis or the clinical trial reaching statistical significance, the future strategy will be: N/A (4) Accumulated investment expenditure incurred: Undisclosed. Upcoming development plan: Estimated date of completion: At authorities' discretion.

After receiving the application, NMPA will review the completeness of submitted documents, followed by a substantial review. The clinical trial may begin if there are no negative opinions or questions raised by NMPA within 60 working days after entering substantial review. The clinical trial is expected to be completed in 2026.

The time of completion is determined by the actual condition of recruitment. Estimated responsibilities: All expenses associated with this clinical trial will be fully covered by GeneScience Pharmaceuticals. Foresee will receive sales royalties up on successful commercialization in China in the future.

Market situation: According to Globalcan statistics, Breast cancer is the most common cancer in women worldwide, with approximately 9.2 million new cancer cases in women worldwide in 2020. Breast cancer accounts for 24.5% of new cases; among new cases of breast cancer globally, China accounts for approximately 18%. Based on the different receptors present on the surface of cancer cells, primarily HR (hormone receptor) and HER2 (human epidermal growth factor receptor 2), breast cancer can be generally categorized into four subtypes: HR+/HER2+, HR+/HER2-, HR-/HER2+, and HR-HER2.

In China, the HR+/HER2-subtype is the most common, accounting for approximately 61% of cases. Hormone therapy is the standard of care (SOC) for the treatment of patients with HR-positive (ER + and/or PR+) /HER2 negative with mild to moderate leukemia involvement on a top of standard the standard of care Tamoxifan. This phase 3 clinical trial are an open-label, randomized.