Taipei – October 12, 2026 -- China's National Medical Products Administration (NMPA) has approved CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for adult patients with advanced prostate cancer, Foresee Pharmaceuticals (TPEx: 6576) said. Licensing partner Changchun GeneScience Pharmaceutical (GenSci) notified Foresee of the approval of the Marketing Authorization Application and will commercialize the product in China.
GenSci holds exclusive China rights across all CAMCEVI indications
The license covers all current and pipeline indications: advanced prostate cancer, central precocious puberty (CPP) and premenopausal breast cancer. Foresee Chairman and CEO Ben Chien said GenSci's China launch will "significantly contribute" to the growth of the company's global CAMCEVI franchise.
Premenopausal breast cancer filing is already under NMPA review
GenSci submitted a supplemental New Drug Application in May 2026 for leuprolide mesylate injectable emulsion in premenopausal breast cancer. The NMPA has accepted it for substantive review. A Phase 3 trial of the 6-month formulation in this indication in China has been completed.
China joins the U.S. and EU among CAMCEVI 42 mg approvals
CAMCEVI 42 mg is a sustained-release GnRH agonist formulation. It has been approved for advanced prostate cancer in the United States since May 2021 and in the European Union since May 2022. Foresee launched it in the U.S. in April 2022. The company says the six-month dosing offers a less-frequent alternative to existing therapies. Product labeling may differ by country.
Foresee's CPP candidate FP-001 hit its Phase 3 primary endpoint
The Casppian Phase 3 trial of FP-001, a 42 mg 6-month formulation for CPP, met its primary endpoint in December 2025 (p-value = 0.0005). Foresee plans to submit a New Drug Application to the U.S. FDA in the second half of 2026 and is building commercial infrastructure to launch the product itself in the U.S. and Taiwan.