CF PHARMTECH (02652) Announces NMPA Approval for ICF004 Investigational New Drug Application

Stock News
06/01

CF PHARMTECH (02652) has announced that the Investigational New Drug (IND) application for ICF004 inhalation powder, a Class I new drug, has recently been approved by China's National Medical Products Administration (NMPA). This product is intended for the treatment of interstitial lung disease (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). ILD is characterized by progressively worsening respiratory symptoms and irreversible decline in lung function, leading to poor prognosis. While oral therapies have been approved, published clinical and real-world data indicate that existing treatments, though able to slow the decline in lung function to some extent, are still associated with limited survival benefits, adverse reaction burdens, and treatment discontinuation. There remains an unmet clinical need globally for therapies that achieve a better balance between efficacy, safety, and long-term treatment adherence. With a potentially first-in-class mechanism of action, this product utilizes an inhaled dry powder delivery route, designed to deliver the drug directly to the affected areas of the lungs. Preclinical studies of the product have shown: (i) a differentiated distribution between lung tissue exposure and systemic blood exposure following inhaled administration, and (ii) observed anti-fibrotic activity with a favorable safety profile in preclinical models. These findings provide research support for the development strategy of enhancing target organ exposure while reducing systemic exposure through localized targeted delivery. However, preclinical results are preliminary, and whether they translate into safety and efficacy in humans remains to be verified in clinical trials. The IND approval for this product marks the entry of the Group's inhaled innovative drug candidate into the clinical development stage, representing a significant milestone with long-term strategic importance. This milestone validates the Group's capability to integrate complex formulations, delivery systems, and device engineering with unmet clinical needs, and to advance innovative drug candidates into clinical development, establishing a replicable R&D paradigm for subsequent innovative projects in respiratory and other therapeutic areas.

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