According to Theravance Biopharma, a marketing application submitted to the Chinese National Medical Products Administration (NMPA) by Viatris for Yupelri revefenacin inhalation solution for the treatment of COPD has been approved. In November 2023, Theravance and Viatris announced positive results from a Phase 3 trial of Yupelri in China and said that Viatris planned a regulatory submission for the following year. Theravance notes that the approval triggers a $7.5 million milestone payment from Viatris to Theravance.
The original development and commercialization agreement between Viatris (then Mylan) and Theravance Biopharma for nebulized revefenacin that was signed in 2015 excluded China. In 2019, the agreement was expanded to add China, Hong Kong, Macau, and Taiwan.
In the US, Yupelri has been approved for the treatment of COPD since 2018. The inhalation solution is delivered via a standard jet nebulizer.
Read the Theravance Biopharma press release
