China-based Huanbo Biotechnology has received investigational new drug (IND) clearance from both China's Centre for Drug Evaluation (CDE) and US regulators for its novel pulmonary arterial hypertension (PAH) candidate, AF02. The molecule, described as a first-in-class therapy designed to reverse vascular remodelling, represents a potential paradigm shift from current treatments that primarily manage symptoms. The dual IND approvals enable the initiation of global multi-centre clinical trials.

Founded in 2021, Huanbo is a cardiovascular disease-focused drug developer. The company's strategy extends beyond PAH, with plans to explore AF02's potential in other conditions with high unmet need, such as heart failure and diabetes. The successful dual-regulatory milestone highlights the company's ambition to advance a pipeline of transformative therapies that address the root causes of serious diseases.

According to PharmCube's NextBiopharm® database, AF02 is entering a highly competitive field, with 70 PAH candidates the clinical stage alone. Click here to request a free trial for NextBiopharm®.