On the 19th, Foresee Pharmaceuticals announced that its new formulation of CAMCEVI (leuprolide injectable emulsion) for prostate cancer has been accepted for substantive review by China’s National Medical Products Administration (NMPA). Based on standard review timelines, the approval process is expected to take approximately 18 to 24 months, with the earliest possible approval anticipated in the second half of 2025.

Foresee Pharmaceuticals stated that its Chinese licensing partner, Changchun GeneScience Pharmaceuticals, had submitted the New Drug Application (NDA) for the six-month formulation of CAMCEVI to the NMPA on February 8, 2024. This long-acting therapy is primarily indicated for the treatment of advanced prostate cancer in adults.

According to GLOBOCAN, a global cancer database, prostate cancer is the second most common cancer among men worldwide. In 2022, prostate cancer accounted for 14.2% of the 10 million new cancer cases in men globally, with China contributing approximately 9% of the total cases.

The six-month formulation of CAMCEVI has already been launched in the U.S. and Germany, with its licensing partner, Accord Healthcare, planning to expand sales to Canada and other countries this year. Additionally, Foresee Pharmaceuticals has submitted an NDA to the U.S. FDA for the three-month formulation of CAMCEVI, aiming for marketing approval by August 2024.

Since the market size for the three-month formulation in the U.S. is more than double that of the six-month version, Foresee Pharmaceuticals expects that once it secures FDA approval in August, it will quickly introduce the product to the U.S. market. This expansion is expected to generate new revenue streams from royalties and milestone payments while also boosting sales of the existing six-month formulation.

Resource: 新癌藥受審 逸達明年添動能