CF PharmTech, Inc. (2652) announced that the investigational new drug application (IND) for ICF004, an inhaled dry powder candidate for treating progressive fibrosing interstitial lung disease, has been accepted by the National Medical Products Administration (NMPA). The compound is a Class 1 chemical drug candidate under registration numbers CXHL2600132/CXHL2600133.
ICF004 targets life-threatening conditions including idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, aiming to deliver medication directly to the lung lesion areas while minimizing systemic exposure. In preclinical studies, ICF004 showed high lung tissue exposure with reduced systemic burden, forming the basis for its development strategy.
The acceptance of the application constitutes a significant regulatory step for CF PharmTech, Inc. However, it does not guarantee eventual market approval, as ICF004 still requires further review and assessment by the NMPA. CF PharmTech, Inc. is advancing subsequent clinical activities in accordance with regulatory requirements.
CF PharmTech, Inc. specializes in complex inhalation formulations and precision drug delivery, employing integrated capabilities that span device engineering, global regulatory filing, and commercialization. The company has established a commercialization network in China and complies with international manufacturing standards, with a goal of expanding further into international markets. The announcement was dated February 24, 2026.