On July 23, 2026, China’s National Medical Products Administration (NMPA) approved the marketing applications for Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray, submitted by Nanchang Gusen Biopharmaceutical Co., Ltd. and Aitme (Suzhou) Medical Technology Co., Ltd.

This marks the first domestically developed generic version of the product approved in China, ending the originator drug’s eight-year market exclusivity and representing a significant breakthrough in China’s development of complex inhalation drug products.

As one of the key maintenance therapies for chronic obstructive pulmonary disease (COPD), Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray has well-established clinical value and is widely recognized as a representative high-end complex formulation. Its successful localization marks an important milestone for China’s pharmaceutical industry.

At DengYueMed, a Hong Kong-based pharmaceutical wholesaler, we continuously monitor developments in China’s innovative medicines, complex formulations, and the global pharmaceutical industry, providing timely market insights and industry updates to our international partners.

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What Is Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray?

Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray (Spiolto Respimat®) is a fixed-dose LAMA/LABA combination inhalation therapy indicated for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

It helps:

• Relieve persistent shortness of breath
• Improve lung function
• Reduce COPD exacerbations
• Improve quality of life

The product combines two long-acting bronchodilators.

1. Tiotropium

Tiotropium is a long-acting muscarinic antagonist (LAMA).

It blocks M3 muscarinic receptors in airway smooth muscle, producing sustained bronchodilation and improving airflow limitation.

2. Olodaterol

Olodaterol is a long-acting β₂-adrenergic receptor agonist (LABA).

It relaxes airway smooth muscle by activating β₂ receptors, providing additional bronchodilation.

Together, these complementary mechanisms provide 24-hour bronchodilation, allowing effective once-daily maintenance therapy.

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What Does China’s First Generic Approval Mean?

The approval of China’s first generic Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray represents an important milestone for both patients and the domestic pharmaceutical industry.

According to publicly available information:

• The originator product was developed by Boehringer Ingelheim
• It was first approved in China in 2018
• Soft mist inhalers are among the most technically challenging respiratory drug products

For many years, no domestic manufacturer successfully developed a generic version.

The simultaneous approval of products from:

• Nanchang Gusen Biopharmaceutical Co., Ltd.
• Aitme (Suzhou) Medical Technology Co., Ltd.

officially ends the originator drug’s eight-year market exclusivity.

This achievement:

• Expands treatment options for COPD patients
• Promotes localization of complex inhalation formulations
• Strengthens China’s inhalation drug manufacturing capabilities
• Provides healthcare professionals with additional therapeutic choices
• May improve accessibility and affordability

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Why Is This Considered a High-End Complex Formulation?

Compared with conventional tablets or injections, inhalation products require both sophisticated pharmaceutical formulations and highly precise drug-device combination systems.

The approved product uses Soft Mist Inhaler (SMI) technology.

Advantages include:

• No propellant required
• Fine mist generation through mechanical energy
• Lower spray velocity for improved lung deposition
• Easier inhalation for elderly patients
• Reduced coordination requirements
• Better treatment adherence

Because soft mist inhalers integrate:

• Pharmaceutical formulation
• Precision engineering
• Aerosol science
• Device technology

they are widely regarded as one of the most technically demanding dosage forms in respiratory medicine.

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Why Do COPD Patients Need Long-Term Maintenance Therapy?

COPD is a progressive respiratory disease characterized by persistent airflow limitation.

It mainly includes:

• Chronic bronchitis
• Emphysema

Common symptoms include:

• Chronic cough
• Sputum production
• Shortness of breath
• Wheezing
• Chest tightness
• Progressive decline in lung function

Although COPD cannot currently be cured, long-term maintenance therapy can:

• Relieve symptoms
• Improve pulmonary function
• Reduce exacerbations
• Lower hospitalization rates
• Improve quality of life

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Global Market Continues to Expand

According to publicly available market data:

• Global sales reached approximately USD 970 million in 2025.
• The United States contributed more than USD 500 million, making it the largest market.

With aging populations and increasing COPD prevalence worldwide, demand for long-acting bronchodilators continues to grow.

Future growth is expected to be driven by:

• Improved inhalation technologies
• Better patient adherence
• High-quality complex formulations
• Expanding global respiratory markets

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Conclusion

The approval of China’s first generic Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray represents a major milestone in China’s complex inhalation drug sector.

As an important maintenance therapy for COPD, the product demonstrates China’s growing capabilities in:

• Complex formulation development
• Drug-device combination products
• High-end inhalation technologies
• Pharmaceutical manufacturing innovation

The simultaneous approval of two domestic manufacturers not only ends the originator product’s eight-year market exclusivity but also reflects China’s continued progress in respiratory medicine.

DengYueMed remains committed to tracking the latest developments in China’s innovative medicines, complex formulations, and high-value generic drugs. We continue to provide timely pharmaceutical news, industry insights, and global sourcing services to healthcare organizations, distributors, pharmaceutical buyers, and partners worldwide.

If you would like to learn more about newly approved medicines in China, complex formulations, or international pharmaceutical supply, stay connected with DengYueMed for the latest industry updates.