Changxi Pharmaceuticals' First Inhaled Modified New Drug NDA Accepted, Advancing Commercialization

VCBeat has learned that on April 22, Hangzhou Chance Pharmaceuticals Co., Ltd. (“Chance Pharmaceuticals”) announced that the National Medical Products Administration (NMPA) had accepted its New Drug Application (NDA) for CXG87, the company’s first Class 2.2 innovative drug (Budesonide and Formoterol Fumarate Powder for Inhalation (IV), Capsule Type).

CXG87 (Budesonide and Formoterol Fumarate Inhalation Powder Capsules [IV]) is a Class 2.2 improved new drug independently developed by Chance Pharmaceuticals for the treatment of respiratory diseases such as asthma. The acceptance of this New Drug Application (NDA) is based on a multicenter, randomized, blinded, active-controlled Phase III clinical trial (Clinical Trial Registration No.: CTR20250298), which aimed to evaluate the clinical efficacy and safety of CXG87 in treating adult bronchial asthma and yielded positive results.

Phase III clinical study results showed that CXG87 met the primary endpoint after 42 days of treatment, demonstrating non-inferior efficacy compared to the active control drug Symbicort.^®Turbuhaler^®, the subjects showed clear improvement in lung function, with favorable trends in terms of asthma symptom relief and reduced frequency of acute asthma exacerbations, and the overall safety profile was comparable to that of Symbicort® Turbuhaler.^®Comparable. Meanwhile, a comparative analysis of clinical benefits in the subpopulation of asthma patients with relatively weaker inspiratory capacity demonstrated that CXG87 accommodates a broader range of inspiratory flow rates, thereby covering a wider population of asthma patients. Based on the clinical advantages and value demonstrated in this study, CXG87 Dry Powder Inhaler is poised to become an optimal therapeutic option for asthma patients.

Chen Donghao, Ph.D., Founder and CEO of Chance PharmaceuticalsShiStatement: CXG87 is the first innovative drug product developed by Chance Pharmaceuticals based on its VFC platform. The acceptance of the marketing application for CXG87 by the National Medical Products Administration (NMPA) marks a significant milestone, validating the scientific rigor and translatability of our VFC platform, as well as the Chance team’s capability to continuously develop innovative inhalation drug delivery solutions.

CXG87 significantly reduces the product's flow dependence through a redesign of classic inhalation products, and improves operability and usage stability to some extent. If approved, CXG87 will help asthma patients, especially those with airflow limitations (such as low inspiratory flow rate or small lung capacity), achieve better asthma control and a better treatment experience.

Dr. Chen Lan, Co-founder and Head of R&D at Chance PharmaceuticalsStatement: We are honored to have Symbicort^®Turbuhaler^®This excellent inhalation product has been further refined and enhanced, and we are delighted to see that CXG87 has achieved positive results in its Phase III clinical trials. CXG87 has demonstrated advantages in numerous aspects, including improvement of lung function in asthma patients, overall asthma control, quality of life, and user satisfaction. The results of the CXG87 Phase III clinical study corroborate its pharmaceutical in vitro studies and Phase I clinical trial findings, thereby providing “closed-loop” validation of the improvements offered by CXG87. We look forward to CXG87 becoming available to benefit a broad population of asthma patients, particularly those with limited inspiratory flow, offering them a superior treatment option.

Asthma is a chronic inflammatory disease of the airways involving multiple cell types and cellular components. It is clinically characterized by recurrent episodes of wheezing, shortness of breath, and possibly chest tightness or cough, accompanied by airway hyperresponsiveness and variable airflow obstruction. Asthma is the most common chronic respiratory disease worldwide, affecting nearly 300 million people globally, of whom only about half achieve good control. In China, the prevalence of asthma among individuals aged 20 years and older is 4.2%, with a patient population approaching 50 million. However, the overall asthma control rate among outpatients is merely 28.5%, indicating that significant challenges remain.^[1]。

The overall control rate of asthma remains suboptimal due to multiple factors, including individual patient disease characteristics (such as inspiratory capacity), inhalation technique, adherence, economic status, and accessibility of healthcare resources. The Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition) recommend a five-step stepwise treatment approach, in whichInhaled Corticosteroids–FormoterolCombination formulations are the preferred medication. However, when patients have insufficient inspiratory capacity to meet the ideal inspiratory flow rate required for inhaled products, pulmonary drug deposition may be inadequate, failing to ensure the expected control efficacy and increasing the risk of acute exacerbations.^[2]。

Chance Pharmaceuticals is a clinical-stage biotechnology company focused on the development of innovative dry powder inhalation (DPI) therapies. Leveraging its two core technology platforms—micronization and mixing, and spray drying—the company has built a diversified product pipeline. Based on the micronization and mixing platform, Chance has developed multiple improved new drugs aimed at enhancing the overall clinical efficacy of classic medications. Utilizing its proprietary spray drying technology, the company has successfully transformed biologics, low-potency drugs, and agents for deep lung or systemic delivery into high-efficiency dry powder inhalation formulations.

The company has established a modern production facility in compliance with the standards of the CDE, FDA, and EMA, achieving full-chain capability coverage from research and development to industrialization. Since its founding in 2015 by senior industry experts, Chance Pharmaceuticals has remained committed to its mission of "driving the realization of clinical value through innovation in respiratory delivery technologies." Through independent innovation and strategic collaborations, the company provides breakthrough therapeutic solutions that genuinely improve the quality of life for patients worldwide.

References

[1] Chinese Thoracic Society. Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition) [J]. Chinese Journal of Tuberculosis and Respiratory Diseases, 2025, 48(3): 208-248.

[2] Song Yuanlin, Zhu Huili, et al. Respiratory Therapy and Pulmonary Function Group of the Respiratory Medicine Branch of the Shanghai Medical Association. Shanghai Expert Consensus on Assessment of Patients’ Inhalation Capability [J]. Shanghai Medical Journal, 2023, 46(1): 1-7.