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2021-10-07

Xbrane Biopharma and AGC Biologics enter into an Agreement to Manufacture Xcimzane™ for Clinical Development

Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE), a leading biosimilar developer, and AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), have entered into an agreement to manufacture Xcimzane™, a Cimzia® biosimilar candidate, for clinical development.

Under terms of the agreement, the companies will work together to upscale the established Xcimzane™ manufacturing process and produce several commercial scale batches for upcoming phase I and phase III clinical trials as well as the Comparability Analytical Assessment required for regulatory filing.

“AGC is a high-quality partner with global manufacturing expertise, and we are pleased to enter into this agreement as the next step in the development of Xcimzane™ towards clinical trials” said Martin Åmark, CEO Xbrane Biopharma.

“We are proud to be the partner of choice for this technically demanding biosimilar throughout the whole clinical phase” said Patricio Massera, CEO AGC Biologics.

Contacts


Martin Åmark, CEO
M: +46 76 309 37 77
E: martin.amark@xbrane.com

Anette Lindqvist, CFO/IR
M: +46 76 325 60 90
E: anette.lindqvist@xbrane.com

About Us


Xbrane Biopharma AB develops biological drugs based on a platform technology that provides significantly lower production costs compared to competing systems. Xbrane’s leading product Xlucane™, a Lucentis® biosimilar candidate, addresses the € 10.4bn ophthalmic VEGFa inhibitor market. Marketing authorization of Xlucane™ is expected for the second half of 2022. Xbrane has additionally two biosimilar candidates in its pipeline targeting € 7.9bn in originator sales. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE.
For more information, visit www.xbrane.com.

Attachments


Xbrane Biopharma and AGC Biologics enter into an Agreement to Manufacture Xcimzane™ for Clinical Development

Författare MFN