Xbrane Biopharma and JOINN Biologics Forge Strategic Partnership to Develop Daratumumab Biosimilar Xdarzane
核心洞察
Xbrane Biopharma AB and JOINN Biologics US Inc. (搜索) announced a strategic partnership to advance Xdarzane, a biosimilar candidate referencing Johnson & Johnson's multiple myeloma (搜索) therapy Darzalex (daratumumab).
JOINN will lead pilot-scale process development and demonstrate analytical similarity, while Xbrane will spearhead global out-licensing and commercialization activities without additional direct development investment at this stage.
Darzalex generated approximately USD 14 billion in net sales in 2025, with loss of exclusivity expected in May 2029 in the US and 2031 in Europe, representing a substantial biosimilar market opportunity.
Xbrane Biopharma AB, a Sweden-based biotechnology company focused on biosimilar development, and JOINN Biologics US Inc. (搜索), a US-based biologics development and manufacturing organization, announced on June 11, 2026, that they have entered into a strategic partnership to develop Xdarzane, Xbrane's biosimilar candidate referencing Darzalex (daratumumab), a blockbuster oncology biologic for the treatment of multiple myeloma (搜索).
Under the terms of the agreement, JOINN will provide customized process development building upon Xbrane's current Xdarzane development program. JOINN will be responsible for further pilot-scale process development, with the goal of demonstrating analytical similarity to the originator product and delivering a commercially viable process yield. Xbrane will lead global out-licensing activities to commercial partners, after which subsequent development steps—including additional development, scale-up, clinical development, regulatory filing, and commercial manufacturing—will be undertaken jointly by both companies.
The partnership structure enables Xbrane to advance the Xdarzane program without additional direct development investments from the company at this stage, a capital-efficient approach that shifts near-term development costs to the collaboration framework.
Complementary Capabilities Drive the Alliance
The collaboration leverages the complementary strengths of both organizations: Xbrane's extensive expertise in biosimilar development, regulatory execution, and commercialization partnerships, combined with JOINN's integrated biologics development and manufacturing service capabilities. JOINN Biologics operates as a global biologics contract development and manufacturing organization (CDMO), offering customized, integrated services across cell line development, process development, analytical development, scale-up, and GMP manufacturing of monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific antibodies, recombinant proteins, and vaccines. The company maintains significant manufacturing capacity with facilities in the United States and China, including 15 × 2,000 L single-use bioreactors at its Beijing facility and a KUBio modular manufacturing suite at its Guangzhou site.
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. (搜索), 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."
The Daratumumab Market Opportunity
Xdarzane is a biosimilar candidate to Darzalex (daratumumab), a CD38 (搜索)-directed monoclonal antibody used in the treatment of multiple myeloma (搜索). According to the announcement, Darzalex generated net sales of approximately USD 14 billion in 2025. The originator product faces expected loss of exclusivity in May 2029 in the United States and 2031 in Europe, opening a substantial window for biosimilar competition in one of the largest oncology biologic markets globally.
Xdarzane is based on Xbrane's patented platform technology for high-yield protein expression. Xbrane has previously demonstrated its biosimilar development capabilities with Ximluci, which received market authorization approval in Europe and was launched during 2023.
Partnership Facilitation
The strategic collaboration was facilitated by BioBridge Solutions, an international life science advisory and business development firm. Jonas Mortensen, CEO of BioBridge Solutions, 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."
Xbrane Biopharma is headquartered in Solna, Sweden, and is listed on Nasdaq Stockholm under the ticker XBRANE.