CF PHARMTECH (02652.HK): ICF001 expands indications after implied approval from NMPA, covering four indications including pulmonary fibrosis

NewTimeSpace News: On 24 August 2026, CF PharmTech, Inc. (stock code: 02652) announced that ICF001, the Group's self-developed long-acting inhaled dry powder drug candidate, has obtained implied approval from the National Medical Products Administration (NMPA) to conduct clinical trials for interstitial lung diseases, namely idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).

The announcement stated that the approval was obtained following the implied approval for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) granted in March 2026, and the product is now permitted to conduct clinical research across four indications covering pulmonary vascular diseases and progressive fibrotic lung diseases. The four indications are expected to be developed based on a common molecular, formulation, delivery device and clinical pharmacology platform, which the Company believes may help improve R&D efficiency; PAH and PH-ILD target pulmonary vascular resistance, exercise capacity and right heart load, while IPF and PPF provide a pathway for the product to enter the progressive fibrotic lung disease field.

Based on the Company's preclinical and formulation work to date, the current design objective is twice-daily dosing, aiming to maintain drug exposure coverage between doses while reducing peak exposure and providing flexibility in dose adjustment or temporary treatment interruption. The Company plans to conduct Phase I clinical trials in China and overseas subject to the required approvals from the relevant overseas regulatory authorities, and currently intends to explore the possibility of future global multi-center development, regional licensing, co-development or other forms of cooperation.

The Company cautioned that drug R&D and commercialization involve significant risks and uncertainties, and there is no guarantee that the clinical trial approval will lead to successful clinical results, marketing approval or commercialization; shareholders and potential investors should exercise caution when dealing in the Company's securities.

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