Theravance Biopharma’s partner Viatris has received China's National Medical Products Administration (NMPA) approval for Yupelri (revefenacin) inhalation solution for maintenance treatment of chronic obstructive pulmonary disease (COPD).
Yupelri is the first once-daily nebulised long-acting muscarinic antagonist (LAMA) approved in China for COPD treatment.
The approval will initiate a one-time payment of $7.5m to Theravance Biopharma from Viatris, anticipated to be disbursed in the third quarter (Q3) of 2025.
Additionally, Theravance Biopharma will gain $37.5m in sales-related milestones and is entitled to receive escalating royalties ranging from 14% to 20% on net sales within China.
Viatris will handle all development and commercialisation aspects of Yupelri in the country.
The NMPA approval supports Theravance Biopharma's financial growth strategy through $131m in cash reserves, along with an influx of $225m from its latest transaction involving Trelegy royalty divestiture to GSK.
Furthermore, the company retains entitlements amounting to 35% of US-generated profits from Yupelri sales and could potentially accrue up to an additional $150m through imminent Trelegy milestone payments from Royalty Pharma.
In the US, Theravance Biopharma received orphan drug designation (ODD) for ampreloxetine, a norepinephrine reuptake inhibitor under development for treating symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).
The advantages of ampreloxetine therapy observed in MSA patients from Study 0170 encompassed an elevation in norepinephrine levels, a positive effect on blood pressure, significant and lasting symptom enhancement, and no indication of exacerbation of supine hypertension.
Pending positive results from its ongoing Phase III CYPRESS study, which is evaluating ampreloxetine’s efficacy over 20 weeks, the company plans a new drug application (NDA) submission seeking full approval for this indication.
