On January 12, 2026 (U.S. time), Runsheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Runsheng Pharmaceutical") announced exciting news: its submitted product Fluticasone Propionate and Salmeterol Inhalation Powder (USAN: Fluticasone Propionate and Salmeterol Inhalation Powder USP, ANDA No.: 214464) has officially obtained marketing approval from the U.S. Food and Drug Administration (FDA). This marks the first-ever FDA approval of a dry powder inhaler (DPI) independently developed by a Chinese pharmaceutical company, representing a pivotal breakthrough for China’s high-end complex drug formulations to penetrate the international mainstream market.

Formulated as a fixed-dose combination therapy integrating a bronchodilator and an inhaled corticosteroid, this product is specifically indicated for the maintenance treatment of reversible airway obstructive diseases such as asthma in adults and pediatric patients.

Picture source: Boteng Pharmaceuticals

01 Originator Background: The Market Foundation of a Multi-Hundred-Billion-Dollar Product

The originator of this product is Advair® Diskus®, developed by the UK-based GlaxoSmithKline (GSK). Approved for U.S. marketing in 2000, it has become a gold-standard medication in the management of airway diseases including asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA data, Advair® Diskus® has achieved global cumulative sales exceeding USD 100 billion, consistently ranking among the world’s top 10 best-selling drugs for many years with peak annual sales hitting USD 9 billion. Despite the expiration of its inhalation device patent in 2016, the extremely high technical barriers prevented the approval of the world’s first generic equivalent by the FDA until 2019. To date, the product still maintains a stable annual sales volume of approximately 12 million units in the U.S. market, demonstrating robust demand 25 years after its launch.
02 Track Analysis: Value Advantages and Generic Development Challenges of Inhaled Formulations
Despite the formidable challenges in generic development, inhaled formulations have emerged as a core competitive track for global pharmaceutical companies, driven by their distinctive value propositions. On one hand, upon successful generic development via the 505(j) pathway for blockbuster inhaled products, these generics can achieve rapid market penetration without massive commercial promotion compared to new inhaled drugs developed under the 505(b)(2) pathway. Particularly in the highly mature U.S. generic drug market, they are poised to capture significant market share, and even surpass the originator product in many cases. On the other hand, inhaled formulations boast long product life cycles and vast market potential, delivering substantial and sustained profitability. For example, albuterol, a first-generation inhaled product, has maintained global annual sales exceeding USD 1 billion nearly 70 years after its launch; similarly, Advair® Diskus®, the originator of the approved product, still records stable annual sales of around 12 million units in the U.S. market over 25 years post-launch, per IQVIA data. Nevertheless, high value comes with extremely high generic development barriers. As high-end complex drug-device combination products, dry powder inhalers have long been monopolized by foreign pharmaceutical giants, stemming from three core challenges in generic replication:

1. Precision Challenge of Bioequivalence: Dry powder inhalers typically deliver drug doses at the microgram level, and the plasma concentration of active pharmaceutical ingredients (APIs) in pharmacokinetic-bioequivalence (PK-BE) clinical trials is only at the picogram level. Achieving complete in-vivo bioequivalence with the originator product imposes an almost stringent requirement on the precision of formulation development and manufacturing process control.
2.Compatibility Challenge of Drug-Device Synergy: The therapeutic efficacy of DPIs depends on the high compatibility between the drug formulation and the inhalation device. Device structure, as well as the aggregation and dispersion behavior of drug and excipients, directly affect the effective lung deposition rate of the drug. This drug-device integration characteristic significantly increases the complexity and timeline of R&D.
3.Stringent Regulatory Standards of the FDA: For such complex generics, the FDA has issued product-specific guidances (PSGs) to encourage and facilitate generic drug development. These guidelines impose rigorous requirements on critical quality attributes (CQAs), including in-vivo and in-vitro bioequivalence studies and device similarity evaluations, with comprehensive and meticulous inspections that raise the market entry threshold.
Notably, Runsheng Pharmaceutical’s approved product was developed in strict compliance with the FDA’s PSG for complex generics, ensuring product quality and regulatory compliance. In addition, the internal structure and mode of operation of its inhalation delivery device are nearly identical to the originator product, which can effectively improve patient compliance, facilitate seamless switching for patients previously using the originator drug, and lay a solid foundation for the company’s rapid market expansion and commercialization in the U.S.
The FDA approval of Fluticasone Propionate and Salmeterol Inhalation Powder also signifies Runsheng Pharmaceutical’s entry into the international high-end complex formulation market, establishing a dual-driver development model of "domestic medical insurance-listed products + U.S.-approved products" and injecting strong momentum into its global development strategy. Going forward, Runsheng Pharmaceutical will continue to fulfill its corporate mission of providing affordable, high-quality inhaled formulations for patients, advancing the launch of core products in mainstream markets such as China and the U.S., benefiting patients worldwide, enhancing its international industry recognition, and setting a benchmark for domestic pharmaceutical companies’ overseas expansion of high-end drug formulations.

>>About Runsheng Pharmaceutical
Founded in October 2014, Runsheng Pharmaceutical is a high-end complex formulation pharmaceutical company focusing on an inhalation drug delivery system platform as its core technology. To date, the company has secured investments from various institutions and enterprises, including Juxin Investment, Heya Pharmaceutical & Healthcare, Boyi Xintian Capital, DT Capital Partners, SDIC Venture Capital, BioDuro-Sundia, China Resources Pharmaceutical Fund, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd., China Resources Innovation Fund, China Resources Shenyin & Wanguo Fund, Industrial Bank Guosen Trust, and Chonqing Changsheng Shenghe Fund.
The company’s current core pipeline consists of drugs for the treatment of asthma and chronic obstructive pulmonary disease (COPD), including Fluticasone Propionate and Salmeterol Inhalation Powder, Fluticasone Propionate Inhalation Powder, Tiotropium Bromide Inhalation Powder, and Indacaterol Glycopyrronium Bromide Inhalation Powder. Among these, the company’s first core product, Fluticasone Propionate Inhalation Powder, obtained marketing approval from the National Medical Products Administration (NMPA) in September 2025 as an exclusive Class 3 chemical drug (Approval No.: National Medical Products Approval H20255465; Specification: 250μg/inhalation, 60 inhalations/box), and was listed as Category B (No. 541) in the 2025 National Medical Insurance Catalog. The Fluticasone Propionate and Salmeterol Inhalation Powder has been filed for marketing approval in the Chinese market in May 2025 and is currently under review.Going forward, the company will continue to advance the approval and commercialization of its core products in countries and regions such as the U.S. and China, striving to provide affordable, high-quality inhaled formulations for patients.