Hansa Biopharma (Nasdaq Stockholm: HNSA), the Lund, Sweden-based biopharmaceutical company, has licensed European and MENA commercialization rights for Idefirix (imlifidase) to SERB Pharmaceuticals for EUR 115 million (USD 134 million), in a deal structured to free up capital for a US regulatory push ahead of a December 2026 PDUFA date. The agreement grants SERB exclusive rights across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and the MENA region, while Hansa retains full US rights to the first-in-class IgG-cleaving enzyme therapy.
Under the terms, Hansa receives EUR 110 million (USD 128 million) upfront at closing, with a further EUR 5 million (USD 5.8 million) contingent on EMA acceptance of a filing for full, unconditional approval of Idefirix. No royalties, commercial milestones, or profit-sharing arrangements were disclosed, making the structure atypical for a licensed biologic with ongoing commercial potential — approximately 96% of the total disclosed value is paid upfront. Closing is subject to foreign direct investment regulatory clearance and is expected within 60 days.
Deal context
Idefirix is a recombinant enzyme derived from Streptococcus pyogenes that cleaves all four subclasses of IgG antibodies at the hinge region, rapidly eliminating circulating immunoglobulins within two to six hours of administration. The mechanism is distinct from conventional immunosuppressants or antibody-targeting biologics: rather than blocking a receptor or inhibiting a signaling pathway, the enzyme directly degrades the antibody molecules responsible for hyperacute rejection in sensitized transplant candidates.
The drug carries a conditional marketing authorization from the EMA for desensitization of highly sensitized adult kidney transplant patients who test positive on crossmatch against an available deceased donor — a population with few alternatives and high rates of waitlist mortality. Full approval remains pending submission of confirmatory data from a post-authorization efficacy study, the long-term follow-up of which SERB will assume upon transfer of market authorization holdership. SERB will also take over an ongoing pediatric study.
In the US, the FDA accepted Hansa's biologics license application for imlifidase in February 2026, assigning a PDUFA action date of December 19, 2026. A clinical trial record for the post-authorization study is available at NCT04935177.