Foresee Pharmaceuticals Co., Ltd. announced registration clinical trial application for CAMCEVI 42 mg (leuprolide injectable emulsion) accepted by China NMPA for substantial review. Date of occurrence of the eventis 2021/12/30, New drug name or code is leuprolide injectable emulsion (i.e. CAMCEVI 42mg 6-month depot formulation), Indication: for the treatment of advanced prostate cancer, Planned development stages: to conduct registration clinical trial and submit marketing authorization application in China.Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Marketing authorization approvals of CAMCEVI 42 mg 6-month depot formulation have been granted in the US and Canada in May 2021 and November 2021, respectively. GeneScience Pharmaceuticals (Foresee's licensing partner in China) submitted a registration clinical trial application for leuprolide injectable emulsion (i.e. CAMCEVI 42 mg 6-month depot formulation) to China NMPA (National Medical Products Administration) in July 2021.

GeneScience Pharmaceuticals has received the acceptance letter from NMPA for substantial review on the registration clinical trial application for leuprolide injectable emulsion (i.e. CAMCEVI 42 mg) on December 30, 2021. The registration clinical trial may begin if there are no negative opinions or questions raised by NMPA within 60 working days after the acceptance for substantial review. After obtaining official approval or the results of statistically significant sense, the future strategy: to conduct registration clinical trial and submit marketing authorization application in China.

Estimated date of completion: the registration clinical trial is expected to complete in 2 to 3 years. Time of completion is determined by actual condition of recruitment.