Healthcare company Fresenius SE & Co KGaA (XETR: FRE) (OTCM: FSNUY) declared on Monday that it has signed an exclusive development agreement with research, development and manufacturing contract organisation WuXi Biologics (2269.HK), securing option rights to up to 37 biosimilar candidates over the next decade. The partnership, described as the largest development agreement announced in the biosimilars industry to date, could expand Fresenius' portfolio from 29 marketed and pipeline molecules to 66, targeting more than EUR370bn in originator sales.
Fresenius will select candidates based on market attractiveness, development risk and expected returns, retaining exclusive global commercialisation rights and the full economics of products brought to market. The portfolio is expected to span 13 therapeutic areas and multiple biologic technologies, with initial development focused on polatuzumab vedotin for diffuse large B-cell lymphoma and teprotumumab for thyroid eye disease.
Development will use WuXi Biologics' global network, while Fresenius will determine the long-term manufacturing strategy for each candidate, including potential transfers to mAbxience, which it wholly owns. The agreement complements Fresenius' existing research and development, collaboration and licensing activities.
Fresenius reiterated its 2030 Biopharma ambition to approximately double revenue compared with 2025, at an earnings before interest and tax margin of around 20%. The agreement extends growth opportunities beyond 2030, with the company expecting to raise its longer-term ambitions significantly. Development spending will scale as candidates progress, funded from operating cash flow without new financing.
HR HealthCare establishes charitable arm
Sobi presents phase 3 gout study results for pozdeutinurad
TME Pharma signs exclusive negotiation agreement with Japan's TMS for NOX-A12 rights
Formation Bio establishes USD600m debut fund for drug development
Ascletis reports positive US Phase II topline results for ASC30 in diabetes
MetaVia announces presentation of DA-1726 Phase 1 data at Precision Liver Symposium
Genmab reports 50% reduction in risk of death in Phase 3 head and neck cancer trial
United Therapeutics receives FDA clearance to advance inhaled PAH therapy into clinical trials
US WorldMeds acquires Orbus Therapeutics
DifGen Pharmaceuticals completes European Decentralised Procedure for Tafamidis 61 mg Capsules
Astellas and Audax Biosciences sign exclusive option and licence agreement for DAX-044
IRLAB Therapeutics receives US patent allowance for Parkinson's drug candidate IRL1117
Thor Medical signs three-year isotope supply agreement with Medicines Discovery Catapult
Enhertu wins EU approval for HER2-positive early breast cancer treatment