2652.HK) Announces NMPA Acceptance of IND Application for ICF004, a Potential First-in-Class Inhaled Dry Powder Candidate Targeting Unmet Needs in PF-ILD 25.02.2026, 04:12 Uhr von EQS News Jetzt kommentieren: 0

Suzhou, China, February 24, 2026 — CF PharmTech, Inc. (HKEX: 2652.HK) (“CF PharmTech” or the “Company”) today announced that the Investigational New Drug (“IND”) application for ICF004, the Company’s internally developed first-in-class (FIC) inhaled dry powder candidate for the treatment of pulmonary fibrosis (a Class 1 chemical drug candidate), has been accepted by the National Medical Products Administration of China (“NMPA”).

The acceptance of the ICF004 IND application marks a key step forward in the Company’s innovative drug research and development efforts and an important milestone in advancing translational innovation based on the Company’s complex respiratory formulation and precision delivery platform. The Company believes progress in the ICF004 program not only supports the clinical development value of a standalone pipeline asset, but also demonstrates its ability to translate high-barrier delivery and formulation platform capabilities into innovative drug clinical development assets.

Addressing Unmet Needs in PF-ILD: Resolving Efficacy-Tolerability Dilemma

ICF004 is intended for the treatment of Progressive Fibrosing Interstitial Lung Disease (“PF-ILD”), a disease area that includes life-threatening indications such as Idiopathic Pulmonary Fibrosis (“IPF”) and Progressive Pulmonary Fibrosis (“PPF”).

PF-ILD is characterized by progressively worsening respiratory symptoms and irreversible decline in lung function, and is generally associated with poor prognosis. Using IPF as a representative condition, publicly available data indicate a median survival of approximately 2.8 years and a 5-year survival rate below 40%, underscoring the substantial clinical burden of disease.

Oral therapies have been approved globally for the treatment of IPF. Public clinical data and real-world evidence suggest that, while existing therapies may slow decline in lung function to some extent, some patients still face limited survival benefit, significant adverse-event burden, and treatment interruption or discontinuation. For patients coping with both disease progression and treatment-related side effects, there remains an urgent global need for next-generation therapies that can better balance safety, efficacy, and long-term treatment adherence.

The Company believes the development rationale for ICF004 is grounded in these unmet needs. The program seeks to explore new delivery and therapeutic pathways on top of existing treatment approaches, with the goal of improving the therapeutic window and patient outcomes.

Improving Therapeutic Window Through the Integration of Mechanism Exploration and Formulation Innovation Through Local Targeted Delivery

Based on the Company’s current development strategy, ICF004 uses an inhaled dry powder delivery route designed to deliver the drug directly to lung lesion areas, thereby increasing local pulmonary exposure while minimizing systemic exposure to the extent possible, in pursuit of a better balance between efficacy and safety.

The Company positions ICF004 as a candidate integrating mechanism exploration and formulation innovation, and continues to conduct mechanistic research and translational validation around fibrosis-related pathological processes, including inflammation, oxidative stress, and fibroblast activation.

Preclinical Findings Demonstrate Differentiated Pulmonary Exposure Profile Supporting Development Strategy

According to the Company’s completed preclinical studies, ICF004 demonstrated differentiated distribution characteristics between lung tissue exposure and systemic blood exposure following inhaled administration. In relevant studies, the Company observed a significant exposure differential between lung and blood, supporting the project’s subsequent development strategy centered on improving target-organ exposure efficiency and reducing systemic exposure burden through local targeted delivery.

In addition, the Company observed anti-fibrotic activity trends for ICF004 in relevant preclinical models. These findings provide supportive information for subsequent clinical development; however, whether they will translate into clinical efficacy and safety advantages in humans remains to be verified in future clinical trials.

Platform Validation: Extending from Complex Formulation to Innovative Drug Translational Capability and Strategic Significance

The acceptance of the ICF004 IND application marks the first time one of the Company’s innovative drug programs has entered the regulatory acceptance stage. The Company believes the strategic significance of this progress is reflected primarily in the following areas:

• Validation of platform translational capability — demonstrating the Company’s ability to integrate complex formulations, delivery systems, device engineering, and unmet clinical needs in advancing innovative drug development programs;
• Strengthening the replicability of R&D pathways — providing methodological and organizational experience for subsequent innovative programs in respiratory and related therapeutic areas; and
• Enhancing capital market understanding of the Company’s platform-based capabilities — helping investors better understand, beyond the complex formulation business alone, the Company’s medium- to long-term capabilities and potential value drivers in combining delivery technologies, device engineering, and innovative drug clinical translation.

Leveraging its capabilities in inhalation delivery, device engineering, regulatory registration, and industrialization, CF PharmTech continues to advance a multi-layered product portfolio and explore opportunities in delivery-enabled innovative drug development across broader disease areas.

Next Steps

The Company will continue to advance subsequent clinical development activities for ICF004 in accordance with NMPA requirements, including clinical start-up preparation, subject enrollment arrangements, and phased data readouts.

At the same time, the Company will prudently evaluate strategic pathways such as independent development and collaborative development based on the project’s clinical progress, resource allocation, and external partnership opportunities, and will fulfill information disclosure obligations in a timely manner in accordance with applicable regulatory requirements.

Important Risks and Disclaimers

Innovative drug R&D involves high investment, long development timelines, and significant risks. Uncertainties remain in the subsequent clinical development, regulatory review and approval, and commercialization process of ICF004. The Company reminds investors to exercise rational judgment and be mindful of the risks associated with investing.

About CF PharmTech

CF PharmTech focuses on the development of complex formulations, small nucleic acid and liposomal drugs, and precision delivery technologies in key therapeutic areas such as respiratory diseases, and has capabilities in inhalation delivery, device engineering, regulatory registration, and industrialization. The Company is advancing a multi-layered product portfolio based on these platform capabilities and continues to explore clinical translation opportunities in innovative drug development.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements relating to the development, clinical progress, regulatory review, and potential commercialization of ICF004, and the Company’s strategic plans and expectations. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, risks related to clinical development, regulatory approval, commercialization, market conditions, and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to update any forward-looking statements, except as required by applicable law or regulation.