Xbrane Biopharma AB (publ) announced that the company has achieved new production successes for Xdivane??, the company's biosimilar candidate to Opdivo®? (nivolumab). Manufacturing for Xdivane??

is now taking place at the scale required for future commercialization and clinical trials. Xdivane?? is a biosimilar candidate to Op Divo®?

(nivOLumab), an immuno-oncology PD-1 inhibitor used in the treatment of various types of cancer. The development program for Xdivane?? are on track for approval and launch at the time of US patent expiration in 2029.

Clinical material will be produced this year, and clinical trials could be initiated first half of 2025. Xbrane has worked actively with the development of Xdivane?? for the past three years, and by the end of 2024 Xbrane will have invested approximately USD25 million in the development program of the biosimilar candidate.

Xbrane is now running an active out-licensing process for Xdivane?? with the ambition to conclude a partnership in the third quarter of 2024. Xdivane??

are considered to be one out of few nivolumab biosimilar candidates in development for Europe and the US that are expected to be offered for out-licensing to commercialization partners. The market for PD-1/PD-L1 inhibitors was estimated to USD45 billion in 2023 and is expected to surpass USD100 billion by 2028. Opdivo®?

is expected to reach USD14 billion in sales by patent expiration. The annual per patient drug cost is over USD100k. The ambition with Xdivane??

is to reduce that cost and enable treatment for more patients and realize important savings for the healthcare systems.