#China #Dublin #Theravance Biopharma #YUPELRI #Viatris

Theravance Biopharma’s Game-Changing Announcement on YUPELRI

Date: June 26, 2025
Theravance Biopharma, Inc. recently announced a major milestone in the management of chronic obstructive pulmonary disease (COPD) with the approval of its drug YUPELRI® (revefenacin) by the National Medical Products Administration (NMPA) in China. This marks the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the region, setting a new standard in respiratory disease management.

Significance of Approval

The approval of YUPELRI comes with a one-time milestone payment of $7.5 million from Viatris Inc., which is responsible for the commercialization of the product in China. This approval does not only bolster Theravance’s financial standing but also paves the way for an array of future revenue opportunities. The company stands to gain up to $37.5 million in additional sales-based milestones and tiered royalties ranging from 14% to 20% on net sales generated in China. Such financial prospects are vital for Theravance, especially as it continues to navigate the complexities of pharmaceutical development.

Financial Position of Theravance Biopharma

As of the end of March 2025, Theravance Biopharma reported having $131 million in cash reserves, strengthened by a recent $225 million sale of TRELEGY royalties to GSK. This foundational financial position allows the company to focus on new therapeutic developments without incurring significant costs for launching YUPELRI in China, as these fall under Viatris’s responsibilities.

Theravance Biopharma's diversified revenue stream will also include 35% of U.S. profits from YUPELRI and the potential for $150 million in near-term milestones related to TRELEGY. These factors illustrate the company’s robust financial health and adaptability in a competitive landscape.

Upcoming Developments

In tandem with its financial advancements, Theravance is nearing the completion of enrollment in its open-label study of ampreloxetine, focusing on symptomatic neurogenic orthostatic hypotension linked with multiple system atrophy (MSA). Ampreloxetine is a unique, investigational norepinephrine reuptake inhibitor that has shown promise in raising norepinephrine levels, thus having a positive impact on blood pressure and overall symptom improvement for MSA patients. With an Orphan Drug Designation in the U.S. for symptomatic nOH, ampreloxetine could represent a significant advancement in treating this rare neurological disorder.

The ongoing CYPRESS Phase 3 study for ampreloxetine aims to evaluate its effectiveness and durability in managing symptoms after extended treatment, and finding success here could facilitate a New Drug Application (NDA) submission.

Conclusion

Theravance Biopharma’s approval of YUPELRI is not merely a formality; it represents a strategic advancement that could redefine COPD treatment protocols in China while driving significant revenue for the organization. This development highlights the importance of collaboration and innovation in pharmaceutical advancements and sheds light on the promising path ahead for Theravance Biopharma amidst evolving healthcare needs.

For more information about their initiatives and products, visit Theravance Biopharma’s official website.

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Theravance Biopharma®, THERAVANCE®, and the Cross/Star logo are registered trademarks. YUPELRI® is a registered trademark of Viatris Specialty LLC.