Foresee Pharmaceuticals announced that it has received notification from its Chinese licensing partner, Changchun GeneScience Pharmaceutical (GeneScience), confirming the submission of a New Drug Application (NDA) for leuprorelin injectable emulsion to the National Medical Products Administration (NMPA) of China. The estimated review period is approximately 18 to 24 months.

The submitted drug, CAMCEVI 42 mg six-month sustained-release formulation, is indicated for the treatment of adult patients with advanced prostate cancer. The approval timeline and final decision will depend on the NMPA’s review process. If approved, GeneScience will be responsible for commercialization and market launch in China.

With an aging population, the number of prostate cancer cases continues to rise. According to data from GLOBOCAN, prostate cancer is the second most common cancer among men worldwide, accounting for 14.2% of the approximately 10 million new cancer cases in males in 2022. In China alone, prostate cancer accounted for approximately 9% of new cases, translating to an estimated 134,000 new diagnoses annually.

Market analysis from Bezis Consulting indicates that the global leuprorelin (leuprolide) market was valued at approximately RMB 17.213 billion (across all indications) in 2023, with the Chinese market accounting for RMB 5.663 billion. By 2029, the global market is projected to reach RMB 23.822 billion, with an estimated compound annual growth rate (CAGR) of 5.1%.

CAMCEVI 42 mg is a prefilled six-month sustained-release injection developed using Foresee’s proprietary extended-release injectable platform. It eliminates the challenges associated with manual mixing of highly potent leuprorelin formulations, which have remained unchanged for over 30 years. In addition to its U.S. market launch, CAMCEVI was introduced in Germany last year. Foresee’s licensing partner, Accord Healthcare, plans to roll out sales in Canada and other markets this year.

Resource: 逸達授權夥伴金賽，前列腺癌新劑型新藥完成中國上市許可申請