Following U.S. President Donald Trump’s recent issuance of an executive order on drug pricing, concerns have emerged over the potential impact on pharmaceuticals sold in the U.S. by Taiwanese companies. In response, Foresee Pharmaceuticals issued a statement on the 16th, indicating that the global market deployment of its 505(b)(2) novel formulation drug, CAMCEVI, is currently unaffected by the recent executive order on drug pricing announced by President Trump.
On May 12, 2025, President Trump signed an executive order titled “Delivering the Most Favored Nation Prescription Drug Prices for American Patients.” Foresee noted that the implications, enforceability, and potential implementation of this executive order remain highly uncertain. A similar order was attempted during Trump’s first term but was ultimately blocked by the courts.
Should such an order be implemented, the potential financial risks are still difficult to assess due to a lack of detail. It is unclear whether the pricing benchmarks would be based on list prices or net prices, which countries would be referenced for price comparisons, whether it would apply to products approved through the 505(b)(2) regulatory pathway, whether products would be required to be manufactured at the same facility, and what ripple effects it may have on drug prices in other countries. Given the many open questions, Foresee believes it is too early to draw any conclusions.
Foresee emphasized that the company has already completed strategic global positioning of CAMCEVI, its 505(b)(2) new formulation drug for prostate cancer, across several major markets. Its market reach is diversified and not limited to the U.S. In 2019, Foresee licensed CAMCEVI to Accord Healthcare in the EU, followed by a licensing deal with Changchun GeneScience Pharmaceutical in China in 2020, and with India’s Intas Pharmaceuticals for the U.S. market in 2021. The six-month 42 mg formulation of CAMCEVI has received marketing approvals in the U.S., Canada, Europe, Taiwan, Israel, and the U.K., and has already been commercially launched in the U.S. (2022) and Germany (2025). The application for marketing approval in China has been accepted and is currently under substantive review.
The three-month 21 mg formulation of CAMCEVI is also under substantive review by the U.S. FDA, with a target review completion date set for August 29, 2025. In Europe, a marketing authorization application was submitted to the EMA in March 2025 and has formally entered the review process. Additionally, a multinational, multi-center Phase III clinical trial for CAMCEVI’s second indication—central precocious puberty in children—is underway. Another Phase III trial for its indication in premenopausal breast cancer is currently being conducted in China.
Resource: 川普美國藥價行政命令市場關注，逸達聲明新劑型新藥CAMCEVI暫無影響
