Chance Pharmaceuticals, a clinical-stage biotech company focused on the research and development of innovative dry powder inhalation (DPI) therapies, announced on Thursday that the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has accepted the new drug application (NDA) for CXG87 (Budesonide and Formoterol Fumarate Powder for Inhalation (IV), hard capsule).

CXG87 is a Class 2.2 innovative drug, an improved formulation of budesonide/formoterol powder, independently developed by Chance Pharma for the treatment of respiratory diseases such as asthma. The company has completed a multicentre, randomised, blinded, positive-controlled Phase III clinical trial which was designed to evaluate the clinical efficacy and safety of CXG87 in adult patients with bronchial asthma and has achieved positive results.

Phase III trial data showed that CXG87 met its primary endpoint of non-inferiority after 42 days of treatment, compared to the active control, Symbicort Turbuhaler.

Patients achieved clear improvements in lung function, and favourable trends were observed in both asthma symptom relief and reduction in the frequency of asthma exacerbations. The overall safety profile of CXG87 was comparable to that of Symbicort Turbuhaler.

Chance Pharmaceuticals also noted that subgroup analysis in asthma patients with relatively weak inspiratory capacity revealed that CXG87 is suitable for a broader range of inspiratory flow rates, potentially covering a wider asthma patient population.