CF PHARMTECH (02652.HK): ICF004 Phase I First Subject Dosed for ILD

NewTimeSpace · 2026/09/22 08:24 · By Zeyu Wu

On 21 September 2026, CF PHARMTECH (02652.HK) announced that its Phase I clinical trial of ICF004, an inhalation powder for interstitial lung disease, has completed enrolment and dosing of its first healthy subject, with further studies planned.

Key Highlights:

ICF004 is a Class 1 chemical drug administered by inhalation and designed to deliver the drug directly to the lungs, increasing local pulmonary exposure while reducing systemic exposure; the trial assesses safety, tolerability and pharmacokinetic characteristics of single and multiple inhaled doses in healthy subjects in the PRC.
Prior to this registration Phase I trial, an investigator-initiated study and a post-formulation-optimisation study showed that subjects generally tolerated the treatment within the evaluated dose ranges, with no serious adverse events reported as at the relevant data cut-off date, and preliminary pharmacokinetic and local exposure results broadly consistent with development expectations.

NewTimeSpace News: On 21 September 2026, CF PharmTech, Inc. (stock code: 02652) announced that the Phase I clinical trial of ICF004 (Class 1 chemical drug), a developing inhalation powder for the treatment of interstitial lung disease (ILD), has completed the enrolment and dosing of its first healthy subject, marking the commencement of the subject dosing stage following approval to conduct the trial.

ILD comprises a heterogeneous group of diseases affecting the pulmonary interstitium; certain types, including idiopathic pulmonary fibrosis and fibrotic ILD with a progressive pulmonary fibrosis phenotype, may continue to progress and lead to deterioration in lung function, and unmet clinical treatment needs remain among the relevant patients. ICF004 is administered by inhalation and is designed to deliver the drug directly to the lungs, thereby increasing local pulmonary exposure while reducing systemic exposure. Preclinical studies conducted by the Company suggest that ICF004 may exert its effects by affecting multiple fibrosis-related biological pathways and specific cell populations, and showed anti-fibrotic activity in certain preclinical fibrosis models.

The Company stated that the Phase I clinical trial is progressing as planned to assess the safety, tolerability and pharmacokinetic characteristics of single and multiple inhaled doses of ICF004 in healthy subjects in the PRC, and that it is conducting preliminary assessment and preparation for subsequent clinical research protocols. The Company cautioned that drug development and commercialisation involve significant risks and uncertainties, and there is no assurance that the trial will yield successful clinical results, obtain marketing approval or achieve commercialisation.

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CF PHARMTECH 02652.HK Clinical Trial