CF PHARMTECH (02652) has announced that its self-developed long-acting inhaled dry powder candidate drug, ICF001, has received implied approval from the National Medical Products Administration to proceed with clinical trials for interstitial lung diseases, encompassing Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). This milestone brings ICF001's coverage to four key indications: PAH, PH-ILD, IPF, and PPF, aligning its product positioning with the latest global generation of long-acting inhaled prodrug development. It also establishes a solid regulatory foundation for the company's future global multi-center clinical planning, registration strategy, and overseas collaboration efforts.

ICF001 is a lung-targeted prodrug formulation, and its long-acting inhaled prodrug design offers significant advantages. The addition of these two new indication studies is expected to substantially elevate the drug's clinical value. The four indications are anticipated to be developed based on a shared molecular, formulation, delivery device, and clinical pharmacology platform, which is expected to boost research efficiency. PAH and PH-ILD target pulmonary vascular resistance, exercise tolerance, and right heart load, while IPF and PPF pave the way for the product's entry into the progressive fibrotic lung disease space.

Based on the company's preclinical and formulation work to date, the current design objective is to administer the drug twice daily, aiming to maintain drug exposure coverage throughout the dosing interval while reducing peak exposure and offering flexibility in dose adjustment or temporary treatment interruption. In China, PAH treatment is trending toward multi-mechanism combination therapy, yet the supply of inhaled formulations and long-acting prodrugs remains limited. Meanwhile, significant unmet clinical needs persist in the PH-ILD, IPF, and PPF fields. Should the product successfully complete clinical development and obtain marketing approval, the company intends to leverage its domestic R&D, inhaled formulation manufacturing, and commercialization capabilities to support patient accessibility.

The company plans to initiate Phase I clinical trials in China while simultaneously preparing to launch domestic and international Phase I studies in parallel. Overseas trials will proceed subject to securing the necessary approvals from relevant foreign regulatory authorities. The company currently aims to explore future possibilities for global multi-center development, regional licensing, co-development, or other forms of collaboration, actively evaluating potential global partnership opportunities.

Dr. Wenqing Liang, Chairman and Executive Director of the company, commented, "The clinical development approvals for ICF001 across four indications represent a major milestone in CF PHARMTECH's transformation from a complex inhaled formulation platform to a global innovative asset. Positive clinical data from international counterparts has demonstrated that long-acting inhaled prodrugs can emerge as a next-generation therapeutic direction with global commercial potential. The company's objective is to validate, through distinct molecular and delivery architectures, whether ICF001 administration can establish a more practical therapeutic window balancing efficacy coverage, peak tolerance, titration flexibility, and dose reversibility. We will accelerate Phase I clinical research in China and overseas, advance development to global registration standards, and actively seek partners capable of amplifying ICF001's global value."