According to Chance Pharmaceuticals, China’s National Medical Products Administration has accepted the company’s NDA for CXG87 budesonide / formoterol DPI for the treatment of asthma. The announcement emphasizes that the formulation is Chance’s own “improved formulation” and not a generic of Symbicort. The company also reported that its Phase 3 trial of CXG87 versus Symbicort in adult asthma patients met its primary endpoint, with the Chance formulation demonstrating non-inferiority. as well as potential benefits for patients with low inspiratory rates.
In October 2025, Chance announced that Huadong Medicine had acquired commercialization rights to CXG87 for mainland China. At that time, the company said that the Phase 3 trial had completed enrollment and that submission of the NDA was expected in the first half of 2026.
Chance Pharma CEO Donghao Chen 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 optimized 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.”
Head of R&D Lan Chen said, “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.”
Read the Chance Pharma press release
