
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On March 27, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's Formoterol Fumarate Inhalation Solution (Changqixiang®) was approved for marketing. This product is mainly used for the maintenance treatment of airway obstruction in patients with chronic obstructive pulmonary disease (COPD). This is Qilu Pharmaceutical's first approved inhalation preparation product, which will bring a new medication option for COPD patients.
Chronic obstructive pulmonary disease (COPD) is one of the common chronic respiratory diseases, with nearly 100 million patients in China. It has become a major public health challenge on par with hypertension and diabetes. This disease not only causes breathing difficulties and a sharp decline in the quality of life for patients, but frequent acute exacerbations of COPD are also a major factor leading to high medical costs. For countless patients and their families, the goal of treatment is to "breathe freely" and return to a quality life.
Formoterol, as a long-acting β2 receptor selective agonist (LABA), is a core medication in the clinical treatment of COPD and asthma. It effectively dilates the bronchi and significantly improves patients' lung function. Formoterol acts quickly and its effect lasts up to 12 hours, making it particularly suitable for patients whose symptoms worsen at night or in the early morning. Formoterol has been included in the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease) as a core treatment for COPD and is also among the first batch of generic drugs encouraged by China's National Health Commission, demonstrating high clinical application value and demand.
Qilu Pharmaceutical Co., Ltd. initiated the development of Formoterol Fumarate Inhalation Solution in 2022. The research and development team conducted systematic research and optimization on formulation composition and production processes, accurately determining key process parameters and control ranges to achieve stabilized production processes and full control over the production procedures, ensuring that all products manufactured at scale meet stringent quality standards. Changqixiang® adopts single-dose individual packaging, fundamentally avoiding the impact of multi-dose packaging on product quality after opening, fully guaranteeing the stability and safety of medication for patients.
The approval and market launch of Changqixiang® not only further enriches Qilu Pharmaceutical's product portfolio in the respiratory treatment field but also enhances the accessibility and convenience of clinical medications. In the future, Qilu Pharmaceutical will continue to focus on the research and development of emerging dosage forms such as inhaled preparations, addressing unmet clinical needs and benefiting more patients.