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Swedish Orphan Biovitrum AB (publ) (Sobi®) has released the company's 2021 Annual and Sustainability Report. The integrated report summarises business and strategy, financial performance and work on sustainability.
Sobi® today announced that its contract with Pfizer for the manufacture of drug substance for ReFacto AF®/Xyntha® (ReFacto) has been amended due to clarity of final order volumes and will now expire in the first quarter of 2024, earlier than the previous expiry date at the end of 2025. Manufacturing of drug substance for ReFacto will be transferred to Pfizer's production unit in Ireland, ensuring continued patient access.
Sobi® today announced that the National Medical Products Administration of China (NMPA) has approved Gamifant® (emapalumab) for use in China. The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. The approval followed the recommendation announced in February 2022.