Runsen Pharma Achieves Historic Milestone with First-Ever FDA Approval for a Chinese-Developed Dry Powder Inhaler

Recently,Chongqing Runsheng PharmaceuticalCore ProductSalmeterol and Fluticasone Propionate Inhalation PowderOfficially received FDA approval in the United States, becoming the first dry powder inhaler independently developed by a Chinese pharmaceutical company to enter the U.S. market.

The Salmeterol Tiotropium Inhalation Powder approved this time is a generic version of GSK's original drug.Advair Diskus (Seretide). This medication is mainly used for the maintenance treatment of asthma in patients aged 4 years and above, as well as for the maintenance treatment of airflow obstruction and prevention of acute exacerbations in patients with chronic obstructive pulmonary disease (COPD). Data shows that in 2022, the sales revenue of Advair Diskus in the U.S. market reached$2.82 billion。

Inhaled preparations are one of the four major complex preparations internationally recognized, and inhalation powder is one of the most technically challenging types, requiring precise pulmonary delivery of drug active ingredients as low as micrograms. Runsheng Pharmaceuticals uses a self-developed special delivery device that can achieve efficient delivery without propellants.The device weighs only about 60 grams, and the drug delivery process takes only 15 seconds., which is revolutionarily convenient compared to traditional nebulization treatments that last more than 20 minutes.

The core support for this approval is the nearly perfect FDA Pre-Approval Inspection (PAI) in August 2023. After a comprehensive 5-day evaluation of Runsheng Pharmaceutical's Chongqing R&D and production base by FDA officials,It was announced on the spot that no observations were found, no Form 483 representing deficiencies was issued, and it was explicitly recommended to approve the product.

This inspection result not only accelerated the review process but also set a quality benchmark for Chinese manufacturing in the high-end formulation field. Prior to approval, Runsheng Pharmaceuticals had completed pharmaceutical research, bioequivalence trials, and clinical endpoint studies as required by the FDA, fully meeting the technical requirements for an ANDA application.

Timeline of Seretide Inhalation Powder Registration in China

Image Source: Pharma Data

Runsheng Pharmaceuticals was founded in October 2014 and is located in Chongqing Liangjiang Shuitu New City. The company focuses on the research and development of high-end complex formulations for respiratory diseases. It adopts a dual filing strategy in China and the United States. In addition to its ANDA application in the United States, another core product of the companyFluticasone Propionate Inhalation PowderSubmitted an application for market launch in China in June 2025, with the hope of becoming the first domestic generic version of this variety to fill the market gap.

Conclusion: With the launch of Seretide Diskus in the U.S. market, Runsheng Pharmaceutical will initiate commercial production. Its Chongqing R&D and manufacturing base will directly serve the world's largest pharmaceuticals market. For tens of millions of asthma and COPD patients globally, this means more options, reduced financial burden, and a brighter future.

Reference Source:

1. PharmaData

2.https://mp.weixin.qq.com/s/vcm197reyXECZ2E0CtfMuw

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