On January 16, it was learned from Liangjiang New Area that the product “Salmeterol and Fluticasone Propionate Powder for Inhalation” (Drug Application Number: ANDA 214464), independently developed by Runsheng Pharmaceutical Co., Ltd. (hereinafter referred to as Runsheng Pharma) located in Shuitu New City, has officially received approval for marketing from the U.S. Food and Drug Administration (FDA). This is also the first inhaled powder product independently developed by a Chinese company to obtain FDA certification.

The two approved specifications for this product include 100/50mcg (micrograms) and 250/50mcg. The product, in the form of a combination therapy (bronchodilator and inhaled corticosteroid), is specifically indicated for the regular treatment of reversible obstructive airway diseases such as asthma in adults and children. The 250/50mcg specification can also be used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

This product has already been submitted for marketing approval in the domestic market in 2025 and is currently undergoing review and approval processes by the National Medical Products Administration. After its launch, it will serve over 45 million asthma patients and 100 million COPD patients in China, further ensuring medication supply for patients with respiratory diseases in the country.

Founded in 2014 in Liangjiang New Area, Runsheng Pharma focuses on the research, development, and production of high-end formulations for treating respiratory diseases, among others, and has now established a specialized production base for inhaled powders. Another core product of the company, “Fluticasone Propionate Powder for Inhalation,” was approved by the China National Medical Products Administration in September 2025 as a Class III generic drug.

Liangjiang New Area

Liangjiang New Area is a state-level development zone established in 2010 in Chongqing, China. It was designed as a key inland economic hub, focusing on advanced manufacturing, logistics, and finance to drive growth in western China. The area represents a major modern urbanization project, transforming former rural and industrial zones into a strategic center for trade and innovation.

Shuitu New City

“Shuitu New City” is a modern urban development project in China, typically referring to a planned satellite city or new district designed to alleviate population density and spur economic growth in a metropolitan region. While specific histories vary by location, such projects are generally part of recent 21st-century urbanization initiatives, transforming previously undeveloped or rural areas into integrated zones for residence, commerce, and industry.

Runsheng Pharmaceutical Co., Ltd.

Runsheng Pharmaceutical Co., Ltd. is a modern Chinese pharmaceutical company, not a historical or cultural site in the traditional sense. It is part of China’s contemporary healthcare and biotechnology industry, focused on the research, development, and manufacturing of medicines. As a relatively recent commercial enterprise, its history is tied to the growth of China’s private pharmaceutical sector in recent decades.

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and the nation’s food supply. It was formally established in 1906 with the passage of the Pure Food and Drugs Act, largely in response to public outrage over unsanitary conditions in food production highlighted by works like Upton Sinclair’s *The Jungle*. Over the decades, its regulatory authority has expanded significantly following public health crises, such as the 1937 Elixir Sulfanilamide tragedy and the thalidomide disaster, leading to stronger laws requiring proof of safety and efficacy for new drugs.

National Medical Products Administration

The National Medical Products Administration (NMPA) is China’s primary regulatory authority for drugs, medical devices, and cosmetics, established in its current form in 2018. It evolved from earlier agencies like the China Food and Drug Administration (CFDA) and is responsible for ensuring the safety, efficacy, and quality of these products through supervision, registration, and approval processes.

China National Medical Products Administration

The China National Medical Products Administration (NMPA) is the primary regulatory authority responsible for overseeing the safety, efficacy, and quality of drugs, medical devices, and cosmetics in China. It was established in its current form in 2018, evolving from previous agencies like the China Food and Drug Administration (CFDA), to centralize and strengthen regulatory oversight. Its history reflects China’s ongoing efforts to modernize its pharmaceutical and healthcare product supervision system to meet international standards.