Foresee Pharmaceuticals Announces China NMPA Approval of CAMCEVI® 42 mg for the Treatment of Advanced Prostate Cancer; Changchun GeneScience Pharmaceutical will Commercialize in China

TAIPEI, Oct. 12, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced that it was notified by its licensing partner, Changchun GeneScience Pharmaceutical Co., Ltd. ("GenSci"), that China's National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for CAMCEVI^® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for the treatment of adult patients with advanced prostate cancer.

Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals stated: "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."

CAMCEVI^® is exclusively licensed to GenSci for commercialization in China across all current and pipeline indications, including advanced prostate cancer, central precocious puberty (CPP), and premenopausal breast cancer.

In addition to the NMPA's approval of CAMCEVI^® 42 mg for advanced prostate cancer described above, GenSci submitted a supplemental New Drug Application (sNDA) in May 2026 for leuprolide mesylate injectable emulsion for the additional indication of premenopausal breast cancer, which has been accepted by the NMPA for substantive review.

About CAMCEVI 42 mg

CAMCEVI^® 42 mg is a sustained-release, ready-to-use, 6-month subcutaneous formulation of leuprolide mesylate, a gonadotropin-releasing hormone (GnRH) agonist, offering a less-frequent, ready-to-use dosing alternative to existing therapies.

It is approved for the treatment of adult patients with advanced prostate cancer in the United States (since May 2021), the European Union (since May 2022), and other markets, and, as announced today, in China. Product labeling may differ by country; please refer to the locally approved prescribing information.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future plans for the commercialization of CAMCEVI^® in China and the expected contribution of CAMCEVI^® to the growth of Foresee's global CAMCEVI^® franchise. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

About Foresee Pharmaceuticals Co., Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.

Foresee's product portfolio includes late and early-stage programs. CAMCEVI^® 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI^® ETM was approved by the U.S. FDA on August 25, 2025. Foresee was notified by its licensing partners of a series of successful 2026 regulatory milestones, including Canada's drug approval in April, the EU's EMA marketing authorization in May, and the UK's MHRA marketing authorisation in August (partnered with Accord Biopharma/Intas and Accord Healthcare). For FP-001, 42 mg 6-month LAI formulation in central precocious puberty (CPP), the Casppian Phase 3 clinical trial successfully reached its primary endpoint in December 2025 (p-value = 0.0005), with an NDA submission to the U.S. FDA planned in the second half of 2026. Foresee is currently building its commercial infrastructure and preparing to launch FP-001 in CPP itself in the U.S. and Taiwan. The Phase 3 clinical trial of CAMCEVI^® 6-month LAI formulation for premenopausal breast cancer in China has been completed, and in May 2026, the licensing partner submitted a marketing authorization application for leuprolide injectable emulsion for the additional indication of premenopausal breast cancer, which has been accepted by China's National Medical Products Administration (NMPA) for substantive review. Building on the success of CAMCEVI's formulation development, Foresee's proprietary SIF technology platform is now expanding into the central nervous system (CNS) field, which represents a potential multi-billion-dollar market. Two CNS-targeted long-acting injectable (LAI) candidates, FP-018 (Cariprazine LAI) and FP-016 (VMAT2 LAI), are expected to enter human clinical trials in late 2027. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. In January 2026, the global rights for the MMP-12 Inhibitor series were exclusively licensed to Primevera Therapeutics LLC for all subsequent R&D. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. www.foreseepharma.com

SOURCE Foresee Pharmaceuticals