Chance Pharma Announces NMPA Acceptance of New Drug Application for Investigational Respiratory Drug CXG87
HANGZHOU, China, May 7, 2026 /PRNewswire/ -- Chance Pharmaceuticals ("Chance" or "Chance Pharma"), a clinical-stage biotechnology company dedicated to the research and development of innovative inhalation therapies, today 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 commercialization.
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, randomized, blinded, positive-controlled Phase III clinical trial (www.chinadrugtrials.org.cn identifier: CTR20250298). The study was designed to evaluate the clinical efficacy and safety of CXG87 in adult patients with bronchial asthma and has achieved positive results.
Phase III 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. 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 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."
Dr. Lan Chen, Co-founder and Head of R&D at 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 III 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 III study are consistent with data from pharmaceutical in vitro studies as well as Phase I 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."
About Asthma
Asthma is a chronic inflammatory disease of the airways involving multiple cell types and cellular components. Clinically, it is characterized by recurrent episodes of wheezing and shortness of breath, which may be accompanied by chest tightness or cough, along with airway hyperresponsiveness and variable airflow obstruction. Asthma is the most common chronic respiratory disease worldwide, affecting nearly 300 million people globally, of whom only approximately half achieve adequate disease control. In China, 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%, highlighting significant unmet medical needs [1].
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. However, if a patient's inspiratory capacity is insufficient to generate the optimal inspiratory flow rate required by an inhaler device, lung deposition of the medication may be inadequate, potentially compromising the expected therapeutic effect and increasing the risk of exacerbations [2].
About Chance Pharmaceuticals
Chance Pharmaceuticals is a clinical-stage biotech company dedicated to the research and development of innovative dry powder inhalation (DPI) therapies. Leveraging two core technology platforms—milling/blending and spray drying—the company has established a diversified product pipeline. Its micronization platform enables the modification of traditional small-molecule drugs to enhance clinical efficacy. And its proprietary spray drying platform enables the transformation of biological macromolecules, low-activity drugs, and deep lung/systemic delivery drugs into highly efficient dry powder inhalation formulations.
The company's state-of-the-art manufacturing facility, designed and built in compliance with CDE, FDA, and EMA standards, enables end-to-end capabilities from R&D to commercial production. Founded in 2015 by seasoned industry veterans, Chance Pharma is guided by the mission to "harness respiratory delivery technology to deliver clinical value." Through both internal innovation and strategic partnerships, the company is committed to providing groundbreaking therapies that significantly improve the quality of life for patients worldwide.
For more information, please visit www.chancepharmaceuticals.com.
Reference
- Chinese Thoracic Society, Chinese Medical Association. Guidelines for the prevention and management of bronchial asthma (2024 edition)[J]. Chin J Tuberc Respir Dis, 2025, 48(3): 208-248.
- Group of Respiratory Therapy and Pulmonary Function Test, Society of Respiratory Medicine, Shanghai Medical Association, Yuanlin Song, Huili Zhu, et, al. Shanghai expert consensus on the evaluation of Drug Inhalation Capacity [J]. Shanghai Medical Journal, 2023,46 (1): 1-7.
Contact Information:
Hangzhou Chance Pharma
Guobao Zhao
[email protected]
+86 571-8630-9565
Astr Partners
Bob Ai
[email protected]
+1 646-389-6658
SOURCE Chance Pharmaceuticals
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