Chance Pharmaceuticals has announced 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). This marks the first NDA submitted by Chance Pharma and represents a significant milestone on the company's path towards product commercialisation.

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 multicenter, randomised, blinded, positive-controlled phase 3 clinical trial. The study was designed to evaluate the clinical efficacy and safety of CXG87 in adult patients with bronchial asthma and has achieved positive results.

Dr. Donghao Chen, Founder and CEO of Chance Pharma, commented, "As the first product developed on our unique VFC platform, the acceptance of NDA for CXG87 by NMPA marks an important milestone, validating the scientific robustness of our VFC platform and the sustained efforts of the Chance team in developing innovative inhaled drug delivery solutions. Through the optimised engineering of a classic inhaled product, CXG87 significantly reduces the impact of inspiratory flow dependence while improving usability and dosing stability. If approved, CXG87 is expected to help asthma patients achieve better disease control and an enhanced treatment experience—particularly those with airflow limitations, such as low inspiratory flow rate or reduced lung capacity."

Phase 3 clinical 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 favorable 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. Notably, 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. Given these clinical advantages, CXG87 is expected to become an ideal treatment option for patients with asthma.

Dr. Lan Chen, Co-Founder and Head of R&D, Chance Pharma, commented, "We were privileged to be able to further refine and enhance a well-established inhaled product, Symbicort Turbuhaler, and are pleased to report positive top-line results from the phase 3 clinical trial of CXG87. CXG87 demonstrated advantages across multiple clinically meaningful endpoints, including lung function, overall asthma control, quality of life, and treatment satisfaction. The findings from the phase 3 study are consistent with data from pharmaceutical in-vitro studies as well as phase 1 clinical trials, building a compelling body of evidence to demonstrate the enhanced clinical profile of CXG87. We look forward to making CXG87 available to asthma patients as soon as possible, offering them a superior therapeutic option."