CF PHARMTECH(02652): NMPA approves the ICF004 Class I new drug IND application.

CF PHARMTECH (02652) announced that the Class I new drug clinical trial application (IND) for ICF004 inhalation powder has recently been approved by the National Medical Products Administration (NMPA) of China. This product is intended for the treatment of interstitial lung diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). ILD is characterized by progressive worsening of respiratory symptoms and irreversible decline in lung function, leading to poor prognosis. Although oral therapies have been approved, clinical and real-world data have shown that existing treatment methods, while to some extent slowing down lung function decline, still have limited survival benefits, adverse reactions, and treatment interruptions. There is an unmet clinical need globally for a therapy that can achieve a better balance between efficacy, safety, and long-term treatment compliance. With its potential global-first mechanism of action, this product utilizes the inhalation dry powder administration route to deliver the drug directly to the affected areas of the lungs. Preclinical studies of the product have shown: (i) differential distribution between lung tissue exposure and systemic blood exposure after inhalation administration, and (ii) observed anti-fibrotic activity and good safety in preclinical models. These research results provide support for the development strategy of improving target organ exposure while reducing systemic exposure through targeted local administration. However, the preclinical results are preliminary, and their translation into human safety and efficacy still needs to be verified in clinical trials. The approval of the product's IND marks an important milestone for the group's inhaled innovative drug candidates entering the clinical development stage, and it is a milestone of strategic significance. This milestone validates the group's ability to integrate complex formulations, delivery systems, and device engineering with clinical unmet needs, and to advance innovative drug candidates into clinical development, laying a replicable research and development paradigm for subsequent innovative projects in the respiratory system and other therapeutic areas.