Shares of CF PHARMTECH (02652) climbed more than 5% in Hong Kong trading, last up 5.46% at HK$16.06 with turnover reaching HK$6.502 million. The company 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, specifically covering idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
With this regulatory green light, ICF001 now spans all four major indications: PAH, PH-ILD, IPF, and PPF. This comprehensive coverage aligns closely with the global development direction of next-generation long-acting inhaled prodrugs, establishing a solid regulatory foundation for the company's upcoming multi-center global clinical deployment, registration strategy planning, and overseas strategic partnerships.
ICF001 is designed as a lung-targeted prodrug formulation, offering notable advantages through its long-acting inhaled prodrug design logic. The addition of these two new indications for clinical research is expected to significantly enhance the drug's clinical value. Within China, PAH treatment has been trending toward multi-mechanism combination therapies; however, the supply of inhaled formulations and long-acting prodrug products remains limited. Meanwhile, the PH-ILD, IPF, and PPF segments still face substantial unmet clinical needs.
Furthermore, the company plans to initiate Phase I clinical trials in China while concurrently preparing to launch Phase I studies both domestically and internationally. Overseas clinical development will proceed subject to securing the requisite approvals from relevant foreign regulatory authorities.