Chance Pharma Receives NMPA Acceptance for Novel Asthma Treatment CXG87 Following Positive Phase III Trial
核心洞察
China's National Medical Products Administration has accepted Chance Pharmaceuticals (搜索)' new drug application for CXG87, an improved budesonide/formoterol powder formulation for asthma treatment.
Phase III clinical trial data demonstrated CXG87 met its primary non-inferiority endpoint after 42 days compared to Symbicort Turbuhaler, with improvements in lung function and asthma symptom relief.
The drug showed particular advantages for patients with weak inspiratory capacity, potentially covering a broader asthma patient population through reduced flow rate dependence.
Chance Pharmaceuticals (搜索) announced that China's National Medical Products Administration (NMPA) has accepted the new drug application for CXG87, marking a significant regulatory milestone for the clinical-stage biotechnology company's first commercial product candidate. The acceptance represents a crucial step toward addressing unmet medical needs in asthma treatment, particularly for patients with inspiratory flow limitations.
Phase III Trial Demonstrates Clinical Efficacy
CXG87, classified as a Class 2.2 innovative drug, is an improved formulation of budesonide and formoterol fumarate powder for inhalation developed independently by Chance Pharma. The company completed a multicenter, randomized, blinded, positive-controlled Phase III clinical trial (CTR20250298) designed to evaluate clinical efficacy and safety in adult patients with bronchial asthma.
The Phase III trial data showed 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, with favorable trends 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.
Addressing Inspiratory Flow Limitations
A notable finding from the Phase III study emerged from subgroup analysis in asthma patients with relatively weak inspiratory capacity. CXG87 demonstrated suitability for a broader range of inspiratory flow rates, potentially covering a wider asthma patient population than existing treatments. This advantage addresses a significant clinical challenge, as insufficient inspiratory capacity can lead to inadequate lung deposition of medication, potentially compromising therapeutic effects and increasing exacerbation risk.
"Through the optimized engineering of a classic inhaled product, CXG87 significantly reduces the impact of inspiratory flow dependence while improving usability and dosing stability," said Dr. Donghao Chen, Founder and CEO of Chance Pharma. "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."
Clinical Advantages Across Multiple Endpoints
Dr. Lan Chen, Co-founder and Head of R&D at Chance Pharma, highlighted the comprehensive clinical benefits observed in the Phase III study. "CXG87 demonstrated advantages across multiple clinically meaningful endpoints, including lung function, overall asthma control, quality of life, and treatment satisfaction," she noted. The findings from the Phase III study showed consistency with data from pharmaceutical in vitro studies as well as Phase I clinical trials.
Significant Unmet Medical Need
The development of CXG87 addresses substantial unmet medical needs in asthma management. Asthma affects nearly 300 million people globally, with only approximately half achieving adequate disease control. In China specifically, the prevalence of asthma among adults aged 20 years and older is 4.2%, representing nearly 50 million patients, while the overall asthma control rate in outpatient settings is only 28.5%.
Poor asthma control is influenced by multiple factors, including individual patient characteristics such as inspiratory capacity, inhaler technique, medication adherence, financial constraints, and access to healthcare resources. The Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition) recommend a five-step stepwise approach, with an inhaled corticosteroid-formoterol combination as the preferred treatment.
VFC Platform Validation
The NMPA acceptance validates Chance Pharma's proprietary VFC platform technology for developing innovative inhaled drug delivery solutions. As the first product developed on this platform, CXG87's regulatory progress demonstrates the scientific robustness of the company's approach to optimizing existing respiratory treatments.
Chance Pharmaceuticals (搜索), founded in 2015, focuses on developing innovative dry powder inhalation therapies using two core technology platforms: milling/blending and spray drying. The company's micronization platform enables modification of traditional small-molecule drugs to enhance clinical efficacy, while its proprietary spray drying platform transforms biological macromolecules and other compounds into highly efficient dry powder inhalation formulations.