Foresee Pharmaceuticals Welcomes Positive CHMP Opinion Recommending Approval of CAMCEVI 21mg, 3-month strength in the European Union for Advanced Prostate Cancer

TAIPEI, March 6, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced that it has received notification from its licensing partner, Accord Healthcare, that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending granting an extension of the marketing authorization for CAMCEVI to include a new 21 mg, 3-month ready-to-use strength of the long-acting injectable formulation for the treatment of advanced prostate cancer.

This CHMP positive opinion is a regulatory milestone for patients living with advanced prostate cancer and the healthcare providers who treat them. CAMCEVI 21 mg is a ready-to-use subcutaneous leuprolide injection that eliminates the complex, multi-step mixing procedures required by traditional therapies. By offering a convenient 3-month dosing interval, CAMCEVI 21 mg complements CAMCEVI 42 mg by providing more options for stakeholders, streamlining the administration process for clinical staff, and also enhancing patient comfort and treatment compliance.

The European Commission (EC), which has the authority to approve medicine for the European Union, will now review the CHMP recommendation. A final decision regarding marketing authorization is expected in the second quarter of 2026.

Under the partnership framework, CAMCEVI is exclusively licensed to Accord Healthcare for commercialization across the European market. The anticipated approval of the CAMCEVI 21 mg 3-month strength will build upon the commercialization of the CAMCEVI 42 mg (6-month formulation), which officially launched in Europe in 2025.

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, while the EU regulatory review for the 3-month version of CAMCEVI is still ongoing. For the second indication of CAMCEVI 6-month LAI formulation, 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 for around mid-2026. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. 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, Foresee has licensed exclusive global rights related to its MMP-12 inhibitor programs to Primevera Therapeutics, LLC. 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 Co., Ltd.