CF PHARMTECH (02652) Global First-in-Class Inhaled New Drug ICF004 Successfully Completes First Healthy Volunteer Dosing in Phase I Clinical Trial, Industry-University-Research Collaborative Innovation Accelerates Breakthrough in Domestic Original Research

Recently, CF PHARMTECH (02652) announced that the Phase I clinical trial of ICF004 (Class 1 chemical drug), the world's first-in-class inhaled powder aerosol for the treatment of interstitial lung disease (ILD), has successfully completed the enrollment and dosing of the first healthy volunteer. This project is a research achievement jointly developed by CF PHARMTECH and Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, marking the candidate drug's official entry into a new stage of human clinical validation. **Targeting Major Clinical Pain Points in Rare Diseases, Breaking Through Existing Treatment Limitations** Interstitial lung disease (ILD), particularly idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), are critical respiratory diseases with extremely poor prognoses. Publicly available clinical data show that the median survival of IPF patients is only approximately 2.8 years, with a 5-year survival rate of less than 40%. Epidemiological data show that between 2018 and 2022, the number of IPF patients in China increased from 237,000 to 264,000, with an increasingly heavy economic and social burden. Currently approved standard-of-care drugs worldwide have limitations including limited survival benefit and poor tolerability, and there is an urgent need among patients for new therapies that can truly delay disease progression and be well tolerated long-term. ICF004, as a new-generation independently developed inhaled anti-ILD drug in China, adopts a dual-track strategy of "mechanism innovation + inhaled delivery." At the mechanistic level, it intervenes in multiple fibrosis-related pathways and can directly act on a key cell population driving early-stage ILD"abnormal intermediate-state epithelial cells"with the potential to delay or even reverse disease progression at the source. In terms of delivery, inhaled administration achieves "precise release" to pulmonary lesions, increasing local exposure of the drug in the pulmonary lesion area while significantly reducing systemic exposure, thereby effectively avoiding or mitigating systemic adverse reactions, striving to break through the clinical limitations of existing oral therapies through the dosing mechanism. **Solid Preclinical Data, Preliminary IIT Validation of Potential** The development of ICF004 is built on detailed basic research. Completed series of preclinical studies have confirmed that the drug possesses clear and significant anti-fibrotic activity, can effectively inhibit the pulmonary fibrosis process, and delay lung function impairment. Before the initiation of formal registered clinical trials, a small-scale investigator-initiated trial (IIT) led by Professor Qu Jieming's team from the Department of Respiratory and Critical Care Medicine at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine"Safety, Tolerability, and Pharmacokinetic Study of Single Administration of ICF004 Nebulized Inhalation Solution in Healthy Subjects"had achieved positive results. All dose groups demonstrated good safety and tolerability, with no serious adverse events observed. After optimizing the drug formulation, in the further conducted "Pharmacokinetic and Safety Study of Single Inhalation of ICF004 in Patients with Interstitial Lung Disease," patients who completed dosing and follow-up also showed good overall safety and tolerability. Preliminary pharmacokinetic and local exposure analyses showed that the target site exhibited ideal high pulmonary concentration characteristics, with local pulmonary exposure significantly higher than peripheral blood systemic exposure, precisely implementing the core development strategy of "targeting the lungs, reducing systemic burden." **Phase I Study Progressing Steadily, Phase II National Multicenter Protocol Already in Preparation** The currently ongoing registered Phase I clinical study is progressing smoothly and efficiently, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of single and multiple inhaled administrations of ICF004 in healthy Chinese subjects. The primary endpoints of the study include treatment-emergent adverse events, clinical laboratory tests, electrocardiograms, pulmonary function tests, and other safety indicators, with secondary endpoints being pharmacokinetic (PK) endpoints. The core objective is to systematically validate the drug's original design intent of "precise targeting of the lungs, significantly reducing systemic exposure." The protocol and layout for the national multicenter Phase II clinical study are also in the preparation stage. Combining the detailed basic research and clinical data from earlier stages, in the upcoming Phase II clinical trial, this innovative drug will further evaluate its clinical efficacy, anti-fibrotic activity, and long-term safety in the ILD patient population. **Platform Value Continues to Be Unleashed, Innovative R&D Paradigm Validated** The completion of first dosing in the registered Phase I clinical trial of ICF004 is not only a key milestone in the product's development but also a powerful demonstration of CF PHARMTECH's dual-driver strategy of "high-end complex formulations + source-innovative drugs." The company has successfully integrated complex formulation R&D, precision delivery systems, and drug delivery device engineering technology, efficiently transforming cutting-edge technologies from the R&D platform into clinical assets, forming a replicable innovative R&D paradigm. In the future, CF PHARMTECH will continue to efficiently advance the clinical development of ICF004, committed to accelerating the translation of this innovative achievement from industry-university-research collaboration, and bringing a new treatment regimen with superior "efficacy-safety-compliance" to ILD patients worldwide as soon as possible.