Recently, Qilu Pharmaceutical's tiotropium bromide inhalation spray (Changqiping® ) was approved for marketing by the National Medical Products Administration. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD, including chronic bronchitis and emphysema) and related dyspnea, improving the quality of life of COPD patients and reducing acute exacerbations. This approval represents another breakthrough for the company in the high-barrier drug-device combination field, further enriching its respiratory system product pipeline and providing new treatment options for clinical practice.
COPD is a heterogeneous lung disease characterized by persistent airflow limitation and corresponding respiratory symptoms. Its core pathological changes include small airway lesions and lung parenchymal destruction. The main symptoms include chronic cough, sputum production, shortness of breath, or dyspnea. In my country, the prevalence of COPD is severe, becoming one of the major chronic diseases seriously endangering national health, alongside hypertension and diabetes. The prevalence of COPD in Chinese adults aged 20 and above is 8.6%, reaching as high as 13.7% in those aged 40 and above, and exceeding 27% in those over 60 years old, with a significant increase with age. The number of patients is nearly 100 million and continues to rise. COPD significantly impacts patients' social participation and independence, affecting not only health, quality of life, and work capacity, but also imposing a heavy personal, family, and socioeconomic burden. Therefore, effectively controlling and alleviating symptoms is an urgent need for both doctors and patients.
Tiotropium bromide is a long-acting anticholinergic drug that binds to muscarinic receptors on bronchial smooth muscle, continuously inhibiting airway constriction, effectively improving lung function, relieving dyspnea, and enhancing quality of life. It is the first-line drug recommended by COPD prevention and treatment guidelines for maintenance therapy. For patients with mild symptoms, newly diagnosed patients, or those at high risk of acute exacerbations but with mild symptoms, single-agent formulations offer a treatment option with a single component, relatively low risk of allergic reactions, long-lasting efficacy, and low likelihood of developing drug resistance with long-term use.
The approval of tiotropium bromide inhalation spray is the result of Qilu Pharmaceutical's R&D team's continuous and in-depth research on inhalation spray technology. As a complex drug-device combination product, the development challenges of inhalation sprays lie not only in the drug itself but also in the performance control of the delivery device. Key technologies such as precise dosage, atomization particle size control, and uniformity of delivery dose have long been monopolized by foreign companies, creating extremely high technological barriers. Faced with this challenge, the R&D team independently overcame the entire technological hurdle of the delivery device, from structural design and atomization mechanism research to process development and industrial production, firmly grasping the core technology of the device in their own hands.
Building upon this foundation, the R&D team conducted systematic research and optimization on the formulation composition, key performance characteristics of the drug delivery device (such as dose uniformity and microparticle dosage), and manufacturing process. They overcame engineering challenges such as batch-to-batch consistency control and long-term stability. By determining key process parameters, they achieved stable and controllable production, ensuring product quality meets stringent pharmaceutical standards. This product utilizes active atomization technology, providing stable dosage output, which helps improve drug deposition in the lungs. Furthermore, it contains no propellants, resulting in minimal drug retention in the oropharynx, reducing local adverse reactions such as pharyngeal irritation and lowering the risk of respiratory infections, thus providing patients with a convenient and reliable drug delivery experience.
Previously, Qilu Pharmaceutical's first inhaled spray—tiotropium bromide olodaterol inhaler (Changyoujie® ) —had been approved for marketing for long-term maintenance treatment of COPD to relieve related symptoms. Both drugs have similar mechanisms of action and are used for maintenance treatment of COPD. The approval of tiotropium bromide inhaler complements the former, providing a wider range of drug options for COPD treatment.
The company will always adhere to the "patient-centered" philosophy, focus on unmet clinical needs, continuously tackle high-barrier core technologies, and contribute to safeguarding the respiratory health of the nation.

Source: https://mp.weixin.qq.com/s?__biz=MzA5Nzg4MjA1NQ==&mid=2683590386&idx=1&sn=f73644f00ac1d1b1bf991a9eaca92b82&chksm=8b9bfaf0ce8169fcd0ed6f7831290f8ba312707521179c4fc55b3814eff02041e9896846e8c5&scene=126&sessionid=0#rd