AstraZeneca's Symbicort DPI Remains Solely Marketed in China with Only One Domestic Applicant

Jan 23, 2026 15:30 CST Updated 15:30

GSK

Pharmaceutical R&D Manufacturer

US TimeBetween January 12, 2026Recently, Runsheng Pharmaceutical Co., Ltd.'s self-developed Salmeterol Tiotropium Inhalation Powder has officially received FDA approval for marketing.

This is the first one for Chinese pharmaceutical companiesThe inhaled powder product that successfully passed the FDA, although a generic version, still holds epoch-making milestone significance.

Inhaled PowderIs widely recognized as high in the industryTechnical WallProduct LineThe development difficulty of a single "drug-device combination" is enough to deter a large number of research and development companies, thus being monopolized by foreign enterprises for many years untilBefore 2024, only imported products were available on the Chinese market.。

The first breakthrough in China was also the Salmeterol Tiotropium Inhalation Powder, which was successfully evaluated by Health Yuan in June 2024, becoming the first domestically produced successful generic inhalation powder in China.

Since then, multiple仿制粉雾剂have been approved, basicallyAll focus on Salmeterol and Fluticasone Inhalation PowderDose.

In addition, there is also a Category 3 first-to-market generic Fluticasone Propionate Inhalation Powder., also from Runsheng Pharmaceutical, showing that this company still has considerable strength in this difficult dosage form.

However, although generic products have been successively launched, the sales situation in 25 years is not optimistic.

Top Sales Rankings of Powder Inhalers in the First Three Quarters of 2025Salmeterol and Fluticasone PropionateInhaled powder ranks second with nearly 1 billion in sales, of which the original research GSK accounts for nearly 97%.

Healthcare Yuan, which passed the evaluation earliest and was launched earliest, has lower sales than those that came later.TurkeyCompanyNeutec, approved by Health Yuan in June 2024, only achieved sales of over five million in three quarters of 2025. In contrast, the latecomer Prudent, approved in March 2025, has already reached one million in just two quarters after its launch, showing a stronger momentum.

Of course, all these sales combined are merely a fraction compared to GSK. The import monopoly of powder inhalers has lasted too long, and market habits have already been deeply ingrained. For generic products to achieve large-scale substitution, it will likely take a very long time.

Source: Mesentech

Although sales are temporarily lagging, the follow-up speed is indeed very fast. From the first to the fifth approval, it took only a short year. The once twenty-year barrier, which even Hengrui stumbled upon, has now collapsed in an instant.

Currently, three companies have completed clinical trials and submitted production applications for this variety, namely Swiss Celon/Simcere, Runsheng Pharmaceuticals, and BrightGene Bio-Medical Technology. The latest applicant, BrightGene Bio-Medical Technology, was just accepted yesterday (January 22).

Source: Mesentech

Interestingly,Runsheng Pharmaceutical has already successfully gone global overseas, but despite an early application in China, it has not yet been approved. The reason is that Runsheng had previously failed once; they submitted for production in September 2024, received a notification in April 2025, and then resubmitted for listing in May 2025. This likely does not involve major issues, but has merely slowed down the progress.

Although GSK still holds 97% of the market share at present, this is already the fastest progressing dry powder inhaler variety in China. It is believed that as more generic products are approved in the future, the process of generic substitution will accelerate.

Besides this variety, another powder inhaler deserves special mention. Its sales revenue in China is twice that of Salmeterol/Fluticasone, but the market is still monopolized by the original research company, with very few enterprises attempting to develop generics.

This product is AstraZeneca's Budesonide/Formoterol Inhalation Powder, with total sales reaching nearly 1.9 billion in 2025 Q1-Q3, exclusively held by AstraZeneca.Also because of this product, AstraZeneca ranks first by a wide margin in the inhalation powder market in China.

Source: Mesentech

AstraZeneca'sBudesonide ForteMoltrup InhalationThe powder inhaler was launched in the United States in 2000, under the trade nameSymbicort (Xin Bi Ke DuKeep), with gasAerosolAnd two types of powder inhalers.

In 2004,The powder inhaler of Symbicort Turbuhaler has been launched in China, and is divided into (I) according to different ratios.II) Two types, both of which are AstraZeneca's exclusive products, with combined annual sales exceeding 2 billion.

This productThis technology is extremely difficult, and AstraZeneca has held global exclusivity for more than twenty years until Mylan's aerosol became the world’s first generic version in 2022.Effect.

After being successfully copied, AstraZeneca took the lead in launching Symbicort Turbuhaler in China in 2024, followed by Mylan's domestic launch in April 2025. Currently, neither product has recorded any sales.

However, no companies in China have successfully仿制信必可都保粉雾剂, and the progress has been relatively slow. The number of companies布局this product is also much fewer compared to沙美特罗替卡松吸入粉雾剂.

Budesonide Formoterol Powder Inhaler is a drug-device combination product,The patent for the compound has long expired, but AstraZeneca uses Turbuhaler®DPI device is one of the most distinctive devices in the field of dry powder inhalation.The device consists of 13 plastic components and a steel spring, with a reservoir that may contain 50, 100, or 200 doses of active pharmaceutical ingredient (API), presenting a high technical barrier.

Currently, there is only one in China.Shanghai New Yellow River Pharmaceutical,Marketing application under Registration Category 4 accepted for review.

In addition, three other companies, Shandong Jingwei, Zhuhai Ruishipuli, and imported Aoliaoan, have been approved for clinical trials.

Source: Mosana Pharmaceuticals

In summary,The two best varieties in China's current powder inhaler market are GSK's.Salmeterol and Fluticasone PropionateInhaled Powder and AstraZenecaBudesonide and Formoterol Inhalation Powder.

The former no longer has technical barriers, but the process of substitution in the imitation market is still relatively slow, while the latter is still in the stage of technological breakthrough in China.

The remaining few powder inhalers still have very small markets and will not be mentioned for now.

Looking back at this successful overseas venture by Runsheng Pharmaceuticals, it can be considered as setting a good example for domestic companies. The monopoly of imported products in China is severe, commercialization is difficult, the overseas market is larger, and going abroad might offer more possibilities.

Reference: Inhalation preparations, Dry powder inhalation preparations

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