China's National Medical Products Administration (NMPA) has granted regulatory approval for YUPELRI® (revefenacin) inhalation solution, marking a significant milestone as the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.
The approval, announced by Theravance Biopharma, Inc. (NASDAQ: TBPH), triggers an immediate $7.5 million milestone payment from partner Viatris Inc., expected to be received in Q3 2025. Under the licensing agreement, Theravance remains eligible for additional sales-based milestones of up to $37.5 million and tiered royalties ranging from 14% to 20% on net sales in China.
Commercial Partnership Structure
Viatris assumes complete responsibility for all aspects of YUPELRI's development and commercialization in China, while Theravance incurs no commercial costs in the region. This arrangement allows Theravance to benefit from the Chinese market expansion without direct investment in local operations.
The approval represents a strategic expansion for YUPELRI, which is already FDA-approved in the United States for maintenance treatment of patients with COPD. The once-daily nebulized formulation offers a differentiated approach to COPD management in the Chinese market.
Financial Impact and Company Position
The milestone payment contributes to Theravance Biopharma's strengthening financial position, which includes $131 million in cash as of March 31, 2025. The company recently received an additional $225 million from the sale of TRELEGY royalties to GSK and maintains 35% of U.S. YUPELRI profits. Theravance also has potential to receive up to $150 million in near-term TRELEGY milestone payments from Royalty Pharma.
Pipeline Development Focus
While expanding YUPELRI's global reach, Theravance continues advancing its wholly-owned ampreloxetine program. The company is nearing completion of enrollment in the open-label portion of CYPRESS, its registrational Phase 3 study evaluating ampreloxetine in symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy.
Ampreloxetine, a once-daily selective norepinephrine reuptake inhibitor, has received Orphan Drug Designation in the United States for treating symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. Previous study results in MSA patients demonstrated increased norepinephrine levels, favorable blood pressure impact, clinically meaningful symptom improvement, and no signal for worsening supine hypertension.
CYPRESS Study Design
The ongoing Phase 3 CYPRESS study (NCT05696717) employs a randomized withdrawal design to evaluate ampreloxetine's efficacy and durability in participants with multiple system atrophy and symptomatic neurogenic orthostatic hypotension after 20 weeks of treatment. The primary endpoint measures change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score.
The study includes four periods: screening, a 12-week open-label period with 10 mg daily ampreloxetine, an eight-week randomized withdrawal phase comparing placebo to continued ampreloxetine treatment, and a long-term treatment extension. Secondary endpoints include changes in the Orthostatic Hypotension Daily Activity Scale for activities requiring standing and walking for short periods.
