Foresee Pharmaceuticals announced on the 26th that its new three-month formulation of CAMCEVI, a prostate cancer therapy, has received marketing approval from the U.S. Food and Drug Administration (FDA). As additional procedures such as obtaining a J-Code are still required, the company expects the official launch and revenue contribution to take place by the end of this year. The drug will be marketed by Foresee’s licensing partner, Accord, the U.S. subsidiary of Intas. Foresee is eligible to receive milestone payments upon approval and commercialization, along with future sales royalties.
The six-month formulation of CAMCEVI has already been approved in the U.S., Canada, Europe, Taiwan, Israel, and the U.K. It was officially launched in the U.S. in April 2022 and later in Germany and Canada in 2025. The therapy has already captured an estimated 15% share of the U.S. market.
However, due to prevailing prescribing practices, the three-month formulation remains the mainstream choice, with a market size more than double that of the six-month version. The approval of this new formulation is expected to accelerate market penetration and revenue recovery, significantly boosting Foresee’s overall performance.
Foresee reported consolidated revenue of NT$231 million for the first seven months of the year, a slight 1.19% decline compared with the same period last year. Net loss per share for the first half was NT$4.04.
Beyond progress in the U.S., Foresee’s partner in mainland China, Changchun GeneScience Pharmaceutical (Jinsai), filed a new drug application for CAMCEVI with China’s National Medical Products Administration (NMPA) on February 8 this year. More recently, it also submitted an application to Singapore’s Health Sciences Authority (HSA) for the 42 mg six-month formulation of CAMCEVI.
According to GLOBOCAN data, prostate cancer is the second most common cancer among men worldwide, accounting for 14.2% of all new cancer cases among men in 2022—about one million new diagnoses.
Research from Nova One Advisor indicates that the global prostate cancer therapeutics market was valued at US$16.46 billion in 2022 and is projected to grow to US$36.54 billion by 2032, representing a compound annual growth rate (CAGR) of 8.3%. The hormone therapy segment, where CAMCEVI is positioned, is expected to be a particularly significant contributor to this expansion.
Resource: 逸達前列腺癌新藥三個月劑型 獲美國FDA上市許可
