Russia Registers First Efanesoctocog Alfa Drug for Haemophilia A as Nanolek Secures EAEU Rights to China's Armocibat
Key Insights
Russia's Health Ministry has granted registration to Sobi's Altuvoct (efanesoctocog alfa), the first drug with this active ingredient approved in the country for haemophilia A (search) in adults and children aged two and older.
Altuvoct will be available in four intravenous dosages (1,000–4,000 IU), with manufacturing distributed across Biogen, Genzyme, and Vetter Pharma-Fertigung, and seven patients have already received the drug since August 2025.
In a separate development, Nanolek (search) secured exclusive EAEU rights to Alphamab's armocibat (search), a subcutaneously administered TFPI (search) inhibitor currently in Phase III trials in China, for bleeding prophylaxis in both haemophilia A (search) and B regardless of inhibitor status.
Russia's Health Ministry has granted a registration certificate to Swedish Orphan Biovitrum (Sobi) (search) for Altuvoct (efanesoctocog alfa), marking the first approval of a drug containing this active ingredient in the country. The therapy is indicated for the treatment and prevention of bleeding in adults and children aged two years and older with haemophilia A (search), according to the state drug registry.
The registration represents a significant expansion of treatment options for Russian haemophilia A (search) patients, who have historically had limited access to extended half-life factor VIII therapies. Efanesoctocog alfa, originally developed by US-based Bioverativ, was acquired by France's Sanofi in a landmark $11.6 billion deal in 2018, with Sobi brought in to continue development and commercialisation. The drug received FDA approval in 2023 and European approval in 2024 prior to its Russian registration.
Manufacturing and Supply Chain
Altuvoct will be manufactured as a lyophilisate for solution for intravenous injection in four dosage strengths: 1,000 IU, 2,000 IU, 3,000 IU, and 4,000 IU. The production network spans multiple countries: US-based Biogen synthesises the active pharmaceutical ingredient, Ireland's Genzyme Ireland Limited produces the finished dosage form, and Genzyme together with Germany's Vetter Pharma-Fertigung handle packaging and filling. The Russian subsidiary of the Swiss company will manage registration and sales within Russia.
Early Patient Access Through Circle of Kindness
In August 2025, the board of the Circle of Kindness foundation added efanesoctocog alfa to its procurement list, shortly after haemophilia A (search) was included among the diseases funded by the state foundation. According to the foundation, seven patients have received Altuvoct since August 2025, providing early access ahead of broader commercial availability.
Sobi has also been working to localise haemophilia drug production in Russia. In 2020, the company signed an agreement with Skopinfarm to gradually localise production of efmoroctocog alfa at the Russian company's plant in the Ryazan region.
Nanolek (search) and Alphamab: A New Subcutaneous Option for the EAEU
In a parallel development, Russian biopharmaceutical company Nanolek (search) and China's Suzhou Alphamab (search) have signed a strategic agreement to bring the drug armocibat (search) to the Eurasian region for bleeding prophylaxis in haemophilia A (search) and B. The agreement was signed during the Russia-China Pharmaceutical Forum in Shanghai.
Under the terms, Nanolek (search) will receive exclusive rights for registration, promotion, and distribution of armocibat (search) in Russia, the Eurasian Economic Union (EAEU) countries, Azerbaijan, and Uzbekistan, and will hold the marketing authorisations. Nanolek views the collaboration as part of expanding its orphan drug portfolio.
Armocibat (search) is administered subcutaneously, offering a more convenient route of administration compared to intravenous injections. Critically, the drug is intended for patients with both inhibitor-positive and inhibitor-negative haemophilia. The drug is currently undergoing Phase III clinical trials in China, with completion expected in mid-2027.
Addressing Unmet Need in Inhibitor-Positive Patients
According to the registry, more than 8,500 patients in Russia have haemophilia A (search) and B. In the inhibitor form of the disease, where the body produces antibodies to clotting factors, standard therapy becomes ineffective. Armocibat (search), as a TFPI (search) inhibitor, would be the first drug in its class for bleeding prophylaxis regardless of the presence of inhibitors in Russian practice, addressing a critical gap in the current treatment landscape.
Nanolek (search), founded in 2011, is listed among systemically important enterprises and manufactures vaccines and orphan drugs. The company's portfolio includes paediatric vaccines—including Russia's first HPV vaccine registered in March 2025—as well as oncology, haematology, and orphan medicines. The company has more than 800 employees and has built one of the largest biopharmaceutical manufacturing complexes in the Kirov region, where it carries out technology transfer, localisation, and industrial production of drugs in line with international GMP standards.