Major Milestone CF PHARMTECH, INC. 2652.HK Announces IND Acceptance for PAH New Drug with a Globally Innovative Improved Mechanism, Marking Another Milestone for Its Precision Drug Delivery Platform

Focused on developing high-value inhalation therapies for pulmonary hypertension (PAH and PH-ILD), with clinical potential to expand into pulmonary fibrosis indications (PF-ILD, including IPF and PPF).

Following the recent acceptance of ICF004, ICF001 is another candidate from the Company’s high-barrier respiratory pipeline to reach this milestone, signaling an accelerated harvest phase for CF PHARMTECH, INC.’s innovative R&D. ICF001 utilizes a prodrug-based mechanism designed to achieve long-acting efficacy. As drugs in this class have already demonstrated blockbuster potential in treating rare and serious pulmonary diseases, ICF001 is positioned to capture significant growth as it expands into new indications.

Addressing Unmet Clinical Needs and Filling a Domestic Treatment Gap

ICF001 targets two critical categories of pulmonary hypertension: WHO Group 1 pulmonary arterial hypertension (PAH) and WHO Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD). Both conditions are associated with poor prognosis and urgently require better treatment options.

• PAH: As a rare and progressive disease, PAH continues to carry a heavy disease burden. Even with current standard therapies, the 5-year survival rate remains only around 50%–60%, and median survival is approximately 4–7 years.
• PH-ILD: Prognosis is even more severe. Pulmonary vascular remodeling caused by interstitial lung disease results in a median survival of only 1.5–3 years, with a 3-year survival rate as low as 25%–40%, making PH-ILD a particularly challenging condition in the pulmonary hypertension field.

Notably, there are currently no approved targeted therapies for PH-ILD in China. The rapid development of ICF001 positions it to potentially become the first inhaled therapy approved for this indication in China, addressing a critical therapeutic void and offering a transformative treatment option for patients worldwide.

Tackling Key Industry Challenges with a Globally Differentiated Improved Mechanism

While the industry is shifting toward long-acting therapies to reduce dosing frequency, existing approaches often face challenges, including single-dose burden, local tolerability, and titration complexity, all of which can affect dose escalation and long-term patient adherence.

ICF001 is designed to address these clinical pain points through precise formulation and pharmacokinetic optimization, with the goal of delivering two key breakthroughs while demonstrating multi-indication expansion potential:

Enhanced patient adherence through reduced dosing frequency

By optimizing molecular structure and formulation, ICF001 increases drug loading efficiency and improves local tolerability, reducing the overall administration burden for long-term therapy.

Optimized pharmacokinetics through a “peak-shaving and trough-filling” profile, balancing safety and efficacy

Delivered directly to the lungs, ICF001 is designed to blunt peak plasma concentration (Cmax) while extending drug exposure (AUC). This “peak-shaving and trough-filling” profile improves systemic tolerability and may enhance clinical efficacy while maintaining safety.

“One drug, Multiple indications” Strategy

Expanding beyond PAH and PH-ILD, ICF001 utilizes a mechanism of action that targets pulmonary fibroblast activation, offering dual potential in pulmonary hypertension and pulmonary fibrosis. Backed by cutting-edge global research and clinical exploration of this drug class, ICF001 is expected to emerge as a next-generation blockbuster, addressing significant unmet needs in the broader respiratory market.

These differentiated advantages represent the Company’s R&D goals and strategic direction based on translational medicine models. If improvements in tolerability and titration efficiency are confirmed in subsequent clinical studies, ICF001 is expected to improve long-term treatment adherence, strengthen efficacy potential, and further expand clinical accessibility.

The rapid acceptance of this IND application marks another critical milestone in the Company’s clinical development of its high-barrier respiratory pipeline. It demonstrates the Company’s solid fundamentals, forward-looking strategic positioning, and efficient execution in innovative drug R&D. Furthermore, it established a strong foundation for the Company to further penetrate the global high-value inhalation therapy market to address unmet clinical needs. The market holds high expectations for the clinical application of such improved new drugs.

Validating Platform Value: Extending from Complex Formulation Capabilities to Innovative Drug Translation

The IND acceptance of ICF001 marks a key transition for CF PHARMTECH, INC.’s inhaled innovative drug program enters the regulatory phase. This progress represents a strategic breakthrough with long-term sustainable development potential:

By leveraging its integrated global capabilities, CF PHARMTECH is building a multi-layered product portfolio centered on the synergy of advanced complex formulations and innovative therapeutics. This strategic focus solidifies the Company’s position in the high-value global inhalation market while enabling the expansion of its proprietary delivery technology into broader therapeutic areas and innovative drug development.