Liangjiang pharmaceutical enterprise enters US market

A staff member (left) uses liquid chromatography to test inhalation powder. [Photo/WeChat account of Liangjiang New Area]

Respirent Pharmaceuticals Co in Liangjiang New Area has achieved a groundbreaking milestone by securing approval from the United States Food and Drug Administration (FDA) for its innovative inhalation powder.

This marks the first instance of a Chinese company independently developing and obtaining FDA approval for such a product, designed to treat reversible obstructive airway diseases, including asthma, in both adults and children.

The inhalation powder is packaged in a device resembling a tape measure, which, upon activation, releases a fine mist that delivers medication directly to the lungs. This advancement enters a market traditionally dominated by pharmaceutical giants such as GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim.

Respirent Pharmaceuticals has invested more than 1.2 billion yuan ($175.30 million) over the past 12 years to develop this product, alongside another domestic offering, Fluticasone Propionate Inhalation Powder.

General Manager Cao Yuan said that his company has established a cutting-edge automated production line for capsule-type inhalation powders, achieving a significant breakthrough in 2018 with the first clinical research samples of the Salmeterol-Fluticasone Inhalation Powder.

The product features a silver aluminum foil strip with 60 evenly spaced blisters, each containing a precise dose of the inhalation powder, ensuring that medication particles, which must be between 1 and 5 microns in diameter, are delivered to the lungs.

Cao attributes this success to robust support from the local government, which provided substantial funding and strategic guidance. The company plans to continue its focus on developing complex formulations for respiratory diseases, aiming to expand its impact across the US, Southeast Asia, and Europe.