First Patient Included In The Pivotal Clinical Trial For Xdivane

Xbrane Biopharma AB (publ) (“Xbrane”) (Nasdaq Stockholm: XBRANE) today announces that the first patient has been enrolled in the pivotal clinical trial for Xdivane (the biosimilar candidate for nivolumab).

As previously communicated, Xbrane and Intas Pharmaceuticals Ltd (Intas) entered into a global license agreement for Xdivane on November 19, 2024. Under the agreement, Intas is the sponsor of the clinical study and will commercialize the product upon approval. The first patient has now been enrolled in the pivotal clinical study, which will form the basis for the approval process with regulatory authorities, including the US FDA and EMA. Xdivane is being developed according to a timeline that allows for launch close to patent expiration in the respective territories. The initiation of the clinical study triggered a milestone payment of EUR 2 million from Intas to Xbrane, which was received in the third quarter of 2025.

About Xdivane
Xdivane is a biosimilar candidate for Opdivo, an immuno-oncology drug (PD1 inhibitor) used in the treatment of various cancers. Sales amounted to approximately USD 8 billion globally in 2023 and are expected to increase to USD 14 billion by 2028.

About Xbrane Biopharma
Xbrane Biopharma AB develops biologics based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates that together address EUR 23 billion in expected annual peak sales of the respective reference drug. The leading biosimilar candidate Ximluci is approved in Europe and launched in 2023. Xbrane's headquarters are located in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com