Major breakthrough! CF PHARMTECH (02652) ICF001 has obtained two more clinical approvals, achieving full coverage of four major indications including IPF/PPF.

CF PHARMTECH (02652) announced that the Groups independently developed long-acting inhaled dry powder candidate drug ICF001 has obtained the National Medical Products Administrations implicit approval to conduct clinical trials for interstitial lung disease (specifically idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)). As a result, ICF001 achieves full coverage of four major indications: PAH, PH-ILD, IPF, and PPF. The product positioning is highly aligned with the global latest generation of long-acting inhaled prodrug research and development direction, laying a solid regulatory foundation for the companys subsequent global multi-center clinical layout, registration strategy planning, and overseas strategic collaborations. ICF001 is a lung-targeted prodrug formulation, with significant design advantages in long-acting inhaled prodrugs. The addition of clinical studies for the two new indications will greatly enhance clinical value. The four indications are expected to be developed based on a common molecular, formulation, delivery device, and clinical pharmacology platform, which will help improve research and development efficiency. PAH and PH-ILD target pulmonary vascular resistance, exercise tolerance, and right heart load, while IPF and PPF provide a pathway for this product to enter the field of progressive fibrotic lung diseases. Based on the companys preclinical and formulation research work to date, the current design goal is to split the daily dosage into two administrations, aiming to maintain drug exposure coverage during the dosing interval while lowering peak exposure and providing flexibility in dose adjustment or temporary interruption of dosing. In China, treatment for PAH has evolved towards multi-mechanism combination therapy, but the supply of inhaled formulations and long-acting prodrug products remains limited, and there are still unmet clinical needs in the fields of PH-ILD, IPF, and PPF. Should this product successfully complete clinical development and obtain market approval, the company intends to leverage its research and development, inhaled formulation manufacturing, and commercialization capabilities in China to support patient accessibility. The company plans to conduct Phase I clinical trials in China, while simultaneously planning to initiate Phase I clinical studies domestically and internationally, and to conduct clinical trials overseas, subject to the necessary approvals from relevant foreign regulatory agencies. The company is currently exploring the possibilities of global multi-center development, regional licensing, co-development, or other forms of cooperation in the future, actively assessing potential global collaboration opportunities. Dr. Liang Wenqing, Chairman and Executive Director of the company, stated: The clinical development license for four indications for ICF001 marks an important milestone in CF PHARMTECHs transformation from a complex inhaled formulation platform to global innovative assets. Positive clinical data from international similar drugs have already proven that long-acting inhaled prodrugs can become a new generation of therapeutic directions with global commercial potential. The companys goal is to verify whether ICF001s administration can establish a more usable therapeutic window between efficacy coverage, peak tolerance, titration flexibility, and dose reversibility through different molecular and delivery structures. The company will accelerate the commencement of Phase I clinical research in China and overseas, advancing development in accordance with global registration standards, while actively seeking partners that can amplify the global value of ICF001.