Xbrane Biopharma AB and JOINN Biologics US Inc. Enter Strategic Partnership to Develop Xdarzane – Xbrane´s Biosimilar Candidate to Darzalex® (Daratumumab)
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
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Solna, Sweden and Richmond, CA, US - Xbrane Biopharma AB (“Xbrane”), a Sweden-based biotechnology company focused on the development of biosimilars, and JOINN Biologics US Inc. (“JOINN”), a US-based leading biologics development and manufacturing organization, today announced that the companies have entered into a strategic partnership featuring customized development services for Xdarzane, Xbrane´s biosimilar candidate referencing Darzalex® (daratumumab).
Under the terms of the agreement, JOINN will provide customized process development based on Xbrane 's current Xdarzane development program. JOINN will be responsible for further pilot-scale process development, to demonstrate analytical similarity to the originator product and deliver a commercially viable process yield. Xbrane will lead global out-licensing activities to commercial partners after which subsequent development steps will be taken by Xbrane and JOINN, including additional development, scale-up, clinical development, regulatory filing and commercial manufacturing. The structure enables Xbrane to advance the Xdarzane program without additional direct development investments from Xbrane at this stage.
The collaboration leverages the complementary strengths of both parties: Xbrane’s extensive expertise in biosimilar development, regulatory execution and commercialization partnerships, and JOINN’s integrated biologics development and manufacturing service capabilities.
Martin Åmark, CEO of Xbrane Biopharma, commented:
“This collaboration with JOINN represents an important strategic step for Xbrane as we continue to expand our biosimilar pipeline targeting large global biologics markets. Daratumumab is a highly important oncology biologic with significant future biosimilar potential, and we believe the combination of JOINN’s strong CMC and manufacturing capabilities together with Xbrane’s regulatory and partnering expertise creates a highly competitive platform for global development and commercialization.”
Tao He, Co-founder and General Manager of JOINN Biologics US Inc., added:
“We are very pleased to enter this partnership with Xbrane. By combining JOINN’s biologics process development and manufacturing capabilities with Xbrane’s biosimilar development experience and global partnering network, we believe this collaboration has the potential to create a high-quality and globally competitive biosimilar product for patients worldwide.”
Jonas Mortensen, CEO of BioBridge Solutions, which facilitated the partnership between the parties, stated:
“We are proud to have supported the formation of this strategic collaboration between Xbrane and JOINN. The partnership brings together highly complementary capabilities across development, manufacturing, regulatory execution and commercialization, creating a strong foundation for the successful development of a daratumumab biosimilar program.”
About Xdarzane
Xdarzane is a biosimilar candidate to Darzalex used in treatment of multiple myeloma. Darzalex generated net-sales of approx. USD 14 billion in 2025 with expected loss of exclusivity in May 2029 in US and 2031 in Europe. Xdarzane is based on Xbrane’s patented platform technology for high-yield protein expression