Changfeng Pharmaceutical (02652), the world's first new inhaled drug, ICF004 successfully completed the first phase I clinical healthy volunteer group administration. Industry-university-research collaborative innovation accelerated breakthroughs in original local research

The Zhitong Finance App learned that recently, Changfeng Pharmaceutical (02652) announced that its first-in-class (first-in-class) phase I clinical trial of ICF004 (chemical drug class 1) for the treatment of interstitial lung disease (ILD) has successfully completed the enrollment and administration of the first healthy volunteer. The project is a scientific research result developed by Changfeng Pharmaceutical in collaboration with Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. The drug candidate has officially entered a new stage of clinical trial in humans.

Anchoring the major clinical pain points of rare diseases and breaking through existing treatment limitations

Interstitial lung disease (ILD), particularly idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), is a critical respiratory disease with a very poor prognosis. According to public clinical data, the median survival time of IPF patients is only about 2.8 years, and the 5-year survival rate is less than 40%. According to epidemiological data, the number of IPF patients in China increased from 237,000 to 264,000 between 2018 and 2022, and the economic and social burden is getting heavier. Currently, standard treatment drugs approved globally have limitations such as limited survival benefits and poor tolerability. Patients are in urgent need of new treatments that can actually slow the progression of the disease and can be tolerated for a long time.

As a new generation of self-developed inhaled anti-ILD drugs in China, ICF004 uses a dual-track strategy of “mechanism innovation+inhalation delivery”. At the mechanistic level, it interferes with multiple fibrosis-related pathways and can directly act on “abnormal intermediate epithelial cells,” a key cell group that drives ILD in the early stages, and is expected to slow or even reverse disease progression at the source. In terms of delivery methods, inhalation administration achieves “accurate release” of lung lesions, increases local exposure of the drug in the lung lesion area, and greatly reduces systemic exposure, thereby effectively avoiding or reducing systemic adverse reactions, and strives to break through the clinical limitations of existing oral therapy in terms of administration mechanisms.

Pre-clinical research data is solid, and IIT has the potential for initial validation

The development of ICF004 is based on detailed basic research. A series of completed preclinical studies have confirmed that the drug has clear and significant anti-fibrosis activity, and can effectively inhibit pulmonary fibrosis process and delay lung function damage.

Prior to the official registration of clinical trials, a clinical study (IIT) initiated by a small-scale researcher 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 — a “study on the safe tolerability and pharmacokinetics of ICF004 atomized inhalation solution in a single dose” — had achieved positive results. All dosage groups showed good safety and tolerability, and no serious adverse events were observed. After optimizing the dosage form, in the “Pharmacokinetics and Safety Study of Single Inhalation of ICF004 in Patients with Interstitial Lung Disease”, the overall safety and tolerability of patients who have completed drug use and follow-up were equally good. Preliminary pharmacokinetic and local exposure analysis showed that the target site showed ideal characteristics of high concentrations in the lungs. Local exposure in the lungs was significantly higher than peripheral blood system exposure, and the core research strategy of “targeting the lungs and reducing the burden on the whole body” was accurately implemented.

Phase I research is progressing steadily, and a Phase II national multi-center program is already being prepared

The ongoing registered phase I clinical study is progressing smoothly and efficiently. The aim is to evaluate the safety, tolerability and pharmacokinetic characteristics of ICF004 for single and multiple inhalation administration in Chinese healthy subjects. The main end points of the study included safety indicators such as adverse events during treatment, clinical laboratory tests, electrocardiograms, pulmonary function tests, etc. The secondary end point was the pharmacokinetic (PK) endpoint. The core goal was to systematically verify the original design intention of the drug to “accurately target the lungs and significantly reduce systemic exposure”.

The national multi-center phase II clinical research plan and layout are also in preparation. Combining detailed basic research and clinical data in the upcoming phase II clinical trial, the innovative drug will further evaluate its clinical efficacy, anti-fibrosis activity, and long-term safety in ILD patient groups.

The value of the platform continues to be released, and the innovative R&D paradigm is verified

ICF004 completed registration for the first phase I clinical administration, which is not only a key point in the development of this product, but also a strong proof of Changfeng Pharmaceutical's “high-end complex formulation+innovative drug at the source” two-wheel drive strategy. The company successfully integrated complex formulation research and development, accurate delivery systems and drug delivery device engineering technology, efficiently transformed cutting-edge technology from R&D platforms into clinical assets, and formed a replicable innovative R&D paradigm.

In the future, Changfeng Pharmaceutical will continue to efficiently promote the clinical development of ICF004. It is committed to accelerating the transformation of this innovative achievement of industry-university-research cooperation and bringing new treatment plans with better “efficacy, safety, and compliance” to ILD patients around the world as soon as possible.