Our history

Sobi traces its origins back to brewing history, having emerged as a subsidiary of Kärnbolaget Aktiebolag Biokemisk Industri. The brewery company's curiosity and commitment to leveraging existing knowledge and using residual products, such as biological material from brewing, for new product areas led to the establishment of a well-equipped laboratory, laying the foundation for a new company and its future.

Their exploration into vitamins, particularly vitamin C, yielded expertise in drying sensitive biological materials. This cutting-edge expertise became essential to the company.

Due to the Second World War, the company was commissioned by the Swedish Armed Forces to manufacture freeze dried blood plasma. After the war, large amounts of unused dried blood plasma remained in warehouses. Based on American research, the company experimented with blood plasma fractionation, which eventually led to the first blood product, Albumin.

In the mid-1940s, research into penicillin also began when the company saw synergy between its knowhow in fermentation and biochemical processes. Over the next decade, several penicillin products were launched. This provided valuable knowledge for future investments in DNA technology.
 

When the company began to expand internationally in the early 1950s, the name was changed to Kabi (Kärnbolaget Aktiebolaget Biokemisk Industri).

In 1957, a collaborative effort with Swedish researchers marked the initiation of the production of the blood-clotting factors fibrinogen and, later, factor VIII. This partnership generated a wealth of knowledge, particularly in proteins, establishing the groundwork for valuable insights that would prove instrumental in the forthcoming projects focused on growth hormones and haemophilia.
 

Plasma fractionation was a core competence of the company. In 1966, Kabi was one of the first in the world to offer factor VIII under the name AHF concentrate Kabi for the treatment of haemophilia. Plasma-derived medicines drastically reduced mortality for persons with haemophilia.

In the late 1960s, the company pioneered growth hormone production through DNA technology. By 1971, they launched the world's first medicine of its kind, significantly benefiting children with short stature, marking a groundbreaking use of DNA technology in medicine.
 

In 1969, the Swedish state acquired 65% of the shares in Kabi. A few years later, the state bought the remaining 35% and the company became a wholly owned subsidiary of Statsföretag.

In 1972, a new group was formed with Kabi as the parent company. Later that year, Kabi and Vitrum merged to form KabiVitrum. 

In the 1980s, the company was one of the pioneers in advancing the development and production of biological medicines through gene technology. One of these products was a blood-clotting factor VIII product for haemophilia.

In the mid-1980s, the company introduced Genotropin, a growth hormone produced using genetic engineering in collaboration with Genentech, with molecules identical to human growth hormone. At the same time, the innovative product KabiPen was launched—a user-friendly injection pen with a two-chamber cylinder, ensuring the separation of liquid and growth hormone until the patient took the medicine. This patient-centric administration approach made Genotropin the world’s most widely used growth hormone.

ReFacto was the first recombinant blood-clotting factor product for haemophilia where the company navigated a DNA technology-based medicine the entire process from gene to patient. The product was launched in the late 1990s and improved life expectancy for people with haemophilia.

The 90s were otherwise marked by numerous company acquisitions, mergers, and shifts in ownership, and in 2001, Biovitrum was formed.
 

In 2002, the company sold its plasma operation as part of efforts to concentrate operations on protein-based and small molecular drugs.

Biovitrum commenced the global manufacturing of the active protein component for the haemophilia product ReFacto for Wyeth (now Pfizer).

The highlight of the year was Biovitrum’s stock exchange listing on Nasdaq Stockholm.

Another significant milestone was signing an agreement with Syntonix (now Sanofi), covering the development and manufacturing of an extended half-life recombinant factor IX Fc-concentrate. This substance was later to become the medicine Alprolix for people with haemophilia B. 
 

The collaboration with Syntonix (now Sanofi) continued with the development of an extended half-life factor VIII Fc for the treatment of haemophilia A, later to become the medicine Elocta. The company reaffirmed its longstanding dedication to advancing haemophilia care through innovative therapies.

Biovitrum obtained an exclusive license for Kineret^®, a medication indicated for the treatment of rheumatoid arthritis. Additionally, the company acquired Kepivance^®, a medicine used for the treatment of oral mucositis, a common side effect of cancer treatment. The acquisition implies an expansion of Biovitrum’s presence in Europe, North America, Australia, and New Zealand. 

Investor AB acquired 21 per cent of the shares in Biovitrum. 

Swedish Orphan International, a pioneer in orphan drugs, was acquired, giving rise to a new company, Swedish Orphan Biovitrum AB (publ), known as Sobi.
This acquisition included Orfadin^®, a medicine for the treatment of hereditary tyrosinemia type 1 (HT-1), along with a portfolio of medicines covered by distribution agreements.

A partnership was established with Affibody AB, a Swedish biotech company, in the field of Interleukin-1 (IL-1), a pivotal factor in inflammatory responses.

Kineret became the first and only FDA-approved treatment for Neonatal-onset Multisystem Inflammatory Disease (NOMID), the most severe form of CAPS, a group of rare autoinflammatory diseases causing uncontrolled overproduction of interleukin-1 (IL-1). Individuals with NOMID may experience a spectrum of debilitating symptoms. The FDA’s approval represented an important milestone in providing effective therapeutic options, hope, and relief to those facing the challenges of NOMID.
 

Sobi was recognised for its achievements, securing the esteemed title of Best Biotech Pipeline at the World Orphan Drug Congress.

Additionally, the company reached a milestone by joining the Large Cap list on the Nasdaq Stockholm stock exchange, marking the first pharmaceutical company in Sweden to achieve this in eight years.
 

Sobi received EURORDIS^®, Rare Diseases Europe, Black Pearl Company Award, for outstanding contributions to the rare disease community.

Committed to making a difference, Sobi partnered with Biogen (now Sanofi) to donate 1 billion international units of haemophilia clotting factor therapy for humanitarian aid programs managed by the World Federation of Hemophilia, ensuring a sustained supply for people with haemophilia in the developing world. 

Elocta for haemophilia A and Alprolix for haemophilia B are approved in several countries, including the US, Canada, Australia, and Japan. These extended half-life factor products enhance bled protection and ease the treatment burden for those living with haemophilia.
 

Sobi achieved a regulatory milestone with the European approval of Elocta, a long-acting recombinant factor VIII product for the treatment of haemophilia A. 

Alprolix successfully secured approval in the EU for the treatment of haemophilia B. Following this, the medicine was subsequently launched in Europe, offering patients an advanced treatment option for managing this bleeding disorder.

The growth journey for Elocta continued and has since the approval been successfully launched in 22 countries. Elocta has demonstrated long-term improvements in joint for patients with haemophilia A, particularly evident after prophylactic treatment.

Sobi achieved additional regulatory milestones, such as the extended indication approval of Kineret for the treatment of Still’s disease in the EU.

Sobi secured the rights to Synagis^® in the US, a medicine to safeguard high-risk infants from serious lower respiratory tract infections caused by RSV.

Expanding the immunology pipeline, Sobi acquired Gamifant^®, for primary haemophagocytic lymphohistiocytosis (HLH), an ultra-rare genetic disease characterised by hyperinflammation.

By acquiring Dova Pharmaceuticals, Sobi reinforces its presence in haematology beyond haemophilia by integrating Doptelet^® into its portfolio, addressing thrombocytopenia (low platelet count) in patients with chronic liver disease.
 

Sobi enhanced its global presence by entering into a collaboration agreement with Apellis, focusing on the development and commercialisation of Aspaveli^®/Empaveli^® for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) outside the US.

In a further strategic step, Sobi partnered with Selecta to license SEL-212, a promising treatment for chronic refractory gout. This collaboration paved way for SEL-212 to progress into a phase 3 study.

Sobi and Sanofi reaffirmed their humanitarian commitment by extending their partnership in support of the World Federation of Hemophilia Humanitarian Aid Program. They pledged an additional 500 million international units (IU) of extended half-life replacement clotting factor therapy.
 

Aspaveli/Empaveli received approval in the US, the EU, and Saudi Arabia for the treatment of patients with paroxysmal nocturnal haemoglobinuria, PNH.

In line with Sobi’s strategy for geographic expansion, an agreement was established with Pint Pharma. This collaboration extends access to Sobi’s medicines in up to seven countries in Latin America, including major markets such as Brazil.
 

Gamifant, for the treatment of HLH, marked a historic achievement as Sobi’s first ever approval in China. Simultaneously, Sobi initiated its first regulatory submissions in Japan for Doptelet and Empaveli. 

During the year, Sobi also entered into a licence agreement with ADC Therapeutics to develop and commercialise Zynlonta^® for use in haematology and other therapeutic areas with large unmet medical needs across Europe and major international markets. Zynlonta received approval in the EU later in 2022 for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
 

Through the acquisition of CTI Biopharma, Sobi expanded its haematology portfolio to include Vonjo^®, which is aiding patients with the blood cancer myelofibrosis.

Sobi entered into a royalty agreement with Sanofi on net sales in the US from Beyfortus^®, approved for preventing RSV in babies and toddlers.

Sobi continued for the second year to be a member of the Dow Jones Sustainability Index Europe (DJSI Europe).