Foresee Pharmaceuticals Co., Ltd. announced last patient enrolled in the China registration clinical trial of leuprolide injectable emulsion in prostate cancer has completed treatment. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Foresee received notice from GeneScience Pharmaceuticals (GenSci), Foresee's licensing partner for China, that the Last Patient Out (LPO) in the China registration clinical trial of leuprolide injectable emulsion for the treatment of prostate cancer has achieved. The open-labeled, single arm, multi-center clinical study enrolled a total of 142 subjects in 68 sites in China.

The topline results are anticipated in the first half of 2024, followed by the submission of a marketing authorization application by GenSci in the second half of 2024. According to the clinical study design, each patient receives two injections of leuprolide injectable emulsion at a 6-month interval. The primary efficacy endpoint is the cumulative probability of suppression of serum testosterone (<50 ng/dL) from week 4 to week 48.

After obtaining official approval or the results of interim analysis or the clinical trial reaching statistical significance, the future strategy will be: Gensci will conduct clinical data analysis, followed by the submission of a marketing authorization application in China. Accumulated investment expenditure incurred: Undisclosed. Upcoming development plan: Estimated date of completion: The topline results of this clinical trial are anticipated in the first half of 2024.