Announcement • Aug 25

CF PharmTech, Inc. Announces Expansion of Indications of ICF001 Following Receipt of Implied Clinical Trial Approvals from the NMPA

CF PharmTech, Inc. announced that ICF001, a self-developed long-acting inhaled dry powder candidate, has obtained implied clinical trial approvals from the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in interstitial lung disease, namely idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. These approvals follow the NMPA’s implied clinical trial approvals obtained in March 2026 for the product to conduct clinical trials in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The product is now cleared to enter clinical studies across four indications spanning pulmonary vascular disease and progressive fibrosing lung disease. The four indications of the product are expected to be developed from a common molecule, formulation, device and clinical pharmacology platform. Based on the company’s preclinical and formulation work to date, the current design objective is to split the daily dose into two administrations (that is, twice-daily dosing), with the intention of maintaining coverage throughout the dosing interval while moderating peak exposure and allowing flexibility in dose adjustment or temporary interruption. In China, treatment of pulmonary arterial hypertension has moved towards combination therapy across multiple mechanisms, but the availability of inhaled and long-acting prodrug products remains limited, and unmet clinical need persists across pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. If the product completes clinical development successfully and obtains marketing approval, the company intends to draw on its domestic research and development, inhalation manufacturing and commercial capabilities to support patient access. The company plans to conduct Phase I trials in China and, subject to obtaining the necessary approvals from the relevant overseas regulatory authorities, overseas. The company currently intends to explore possible global multi-centre development, regional licensing, co-development or other forms of collaboration in the future. The company will assess potential opportunities having regard to the maturity of the clinical data. Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, there are substantial risks and uncertainties in the process of drug research, development and commercialization. There is no assurance that the approval of clinical trials will result in the achievement of successful clinical results, the grant of marketing approval or the realization of commercialization.

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CF PharmTech, Inc. Announces Expansion of Indications of ICF001 Following Receipt of Implied Clinical Trial Approvals from the NMPA

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