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Health Yuan's salmeterol/fluticasone inhalation powder for aerosol application has been accepted for market approval, breaking through international technological barriers.
Published Time：
2023-02-09
On the evening of February 8, Jiankangyuan (600380.SH) announced that it had recently submitted an application for the registration and listing of domestically produced drugs for salmeterol/fluticasone propionate inhalation powder to the National Medical Products Administration (NMPA), and recently received an acceptance notice. According to the website of the Center for Drug Evaluation (CDE) of the NMPA, since the CDE released the "Guidelines for Bioequivalence Studies of Orally Inhaled Formulations" in December 2020, Jiankangyuan is the first domestic company to submit an application for the listing of this product and receive acceptance. As of the date of this announcement, no generic drugs have been marketed domestically.
Salmeterol/fluticasone propionate inhalation powder is used for the regular treatment of reversible obstructive airway diseases, including asthma and chronic obstructive pulmonary disease. Salmeterol provides long-lasting bronchodilation, while fluticasone propionate controls inflammation and reduces acute exacerbations. Salmeterol/fluticasone propionate inhalation powder is a combination drug (which can be understood as a bronchodilator and an inhaled corticosteroid), providing a more convenient treatment option for patients who are currently using both β-agonists and inhaled corticosteroids.
The original research product of salmeterol/fluticasone propionate inhalation powder is Seretide® from GlaxoSmithKline. According to data from YaZhiwang, the global sales of Seretide® in 2021 were approximately RMB 12.009 billion. The inhaled drug market in China has long been dominated by foreign pharmaceutical companies, and this market has been called "the most high-end and difficult segment in the generic drug field."
As the first domestic application for the listing of salmeterol/fluticasone propionate inhalation powder to be accepted, Jiankangyuan's product will break the international monopoly, providing more high-quality and cost-effective choices for domestic asthma and COPD patients in the future, and accelerating the process of domestic substitution of inhaled preparations.
Currently, Jiankangyuan already has 7 varieties and 11 specifications of inhaled preparations approved for marketing, with more than 30 projects under research. The future development and marketing of more drugs will continuously consolidate Jiankangyuan's leading position in the inhaled preparation sector.
Source: China.com.cn
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