China’s NMPA clears Foresee’s Camcevi 42 mg for prostate cancer

The company was informed of the decision by its domestic licensing partner, Changchun GeneScience Pharmaceutical (GenSci).

GenSci holds exclusive Chinese commercial rights to Camcevi across all existing and developmental indications, covering central precocious puberty, premenopausal breast cancer, and advanced prostate cancer.

The therapy is a ready-to-use, six-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist developed as an alternative to existing treatments.

Foresee Pharmaceuticals chairman and CEO Dr Ben Chien said: “We are pleased that our partner GenSci will be launching Camcevi 42 mg in China. These efforts will significantly contribute to the growth of our global Camcevi franchise.”

The 42 mg formulation is approved for adult advanced prostate cancer across Canada, China, the European Union (EU), Israel, Taiwan, the UK, and the US, where commercial sales started in April 2022.

Outside China, licensing partners Accord Biopharma/Intas and Accord Healthcare support the franchise, which includes the EU approval from May 2022 and the US Food and Drug Administration’s (FDA) approval of Camcevi ETM in August 2025.

In China, regulators are reviewing a supplemental application filed in May 2026 for leuprolide injectable emulsion in premenopausal breast cancer after a completed Phase III trial.

Foresee Pharmaceuticals based in Taiwan and the US, is preparing commercial operations in Taiwan and the US for FP-001 in central precocious puberty following Phase III Casppian trial results in December 2025.

The company plans to file a US application in the second half of 2026. Its formulation technology is also expanding into the multi-billion-dollar central nervous system sector, with candidates FP-016 and FP-018 scheduled for clinical trials in late 2027.

Pipeline assets also include aderamastat (FP-025), which completed a Phase II study; linvemastat (FP-020), which completed Phase I evaluation; and mirivadelgat (FP-045), which entered the Phase II WINDWARD trial in the second quarter of 2025.

Rights to aderamastat and linvemastat were licensed to Primevera Therapeutics in January 2026.

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