02:51 AM EDT, 08/24/2026 (MT Newswires) -- Bayer (BMW.F) secured approval from the Japanese Ministry of Health, Labour, and Welfare for sevabertinib, or Hyrnuo, to treat HER2 mutation-positive unresectable advanced or recurrent non-small cell lung cancer. The approval is backed by data from the ongoing phase 1/2 Soho-01 trial, in which Hyrnuo achieved a primary endpoint of objective response rate of 75.3%, a median duration of response of 12.2 months, and median progression-free survival of 13.5 months, according to a Monday release. Hyrnuo is the first targeted therapy approved in Japan for the indication that can be used regardless of the line of therapy, including as a first-line treatment. The German life science company previously secured the US Food and Drug Administration's approval for Hyrnuo in patients with previously treated advanced HER2-mutant NSCLC. China's National Medical Products Administration also cleared the drug as a monotherapy for adults with unresectable, locally advanced, or metastatic NSCLC whose tumors have HER2 activating mutations.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.