Aderamastat

TAIPEI, July 9, 2026 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the appointment of Brian J. Groch as Chief Commercial Officer, effective July 1, 2026. In this strategic executive role, Brian will oversee Foresee's global commercial launch strategy and preparations for FP-001 42 mg (six-month ready-to-use subcutaneous long-acting injectable of leuprolide mesylate) for the treatment of central precocious puberty (CPP) in the United States, Taiwan, and potentially other markets. Brian is a seasoned healthcare executive with more than 30 years of industry background and experience in the pharmaceutical industry including multiple leadership roles at Remi Therapeutics, Shield Therapeutics, Veru Inc., and Horizon Therapeutics. He has many years of experience leading global market access strategies and commercial executions, successfully driving the commercialization and market adoption of various treatments across multiple disease areas. Prior to his executive roles, he worked as a Director of Health Policy and Regional Sales at Novartis and spent more than 13 years working for Merck on large-scale commercial and marketing management programs. "I am pleased to announce that Brian J. Groch has joined Foresee as Chief Commercial Officer," said Dr. Ben Chien, Ph.D., Chairman and Chief Executive Officer of Foresee Pharmaceuticals. "Brian will lead Foresee in building a commercial team to launch the FP-001 for the treatment of CPP patients in the U.S., Taiwan, and potentially other selected countries. We are excited that Foresee will build upon our R&D success and transition into a new phase of building direct commercialization capabilities." Foresee is systematically executing its global regulatory roadmap for the CPP program: U.S. Market: The New Drug Application (NDA) submission to the U.S. FDA is targeted for the second half of 2026. Global Markets: Marketing authorization applications will be submitted to health agencies in Taiwan and other strategic territories between late 2026 and the first half of 2027. Ongoing Initiatives: Engage in pre-NDA meetings and regulatory discussions to ensure a streamlined review process. About Central Precocious Puberty (CPP) Central Precocious Puberty is a condition characterized by premature activation of the pituitary-gonadal axis, leading to early puberty. If left untreated, CPP can result in accelerated bone maturation and reduced final adult height, as well as significant psychosocial challenges for affected children. The current standard of care involves treatment with GnRH agonists to halt pubertal progression. About FP-001 42 mg FP-001 42 mg is an investigational, sustained-release ready-to-use, subcutaneous formulation of leuprolide mesylate being developed for the treatment of CPP. It is designed to provide continuous suppression of gonadotropin secretion for 6 months following a single subcutaneous injection, offering a less-frequent, ready-to-use dosing alternative to existing therapies. 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 in April and May 2026 regarding the successful drug approvals in Canada and the granting of EMA marketing authorization in the EU. 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. 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 acetate 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. SOURCE Foresee Pharmaceuticals Co., Ltd. 21% more press release views with Request a Demo