China-based drugmaker SinoCellTech (formerly known as Shenzhou Cell) announced on 23 July 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its recombinant human coagulation factor VIII (susoctocog alfa) copy biological Anjian.
Human blood coagulation factor VIII is an essential blood-clotting protein, also known as anti-haemophilic factor (AHF). Recombinant factor VIII is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It can also be used in those with von Willebrand’s disease (an inherited bleeding disorder caused by lack of von Willebrand factor).
HLX03 has been approved by the NMPA for the control and prevention of bleeding in adults and adolescents (≥ 12 years old) with haemophilia A in China. It is the first domestically made factor VIII product to be approved for marketing in China.
Anjiain is a third-generation recombinant human coagulation factor VIII. It began research and development in 2008, entered clinical phase III in 2016 and completed clinical phase III research in 2019. The results of the phase III study showed that, compared with imported products, Anjiain has the same therapeutic effect. There were no coagulation factor inhibitors observed in the treated patients and the safety profile is good.
Due to the generally low level of diagnosis and treatment and the shortage of treatment drugs in China, many patients with haemophilia do not receive adequate and timely treatment. With the cost advantage that Anjiain is expected to bring, it is hoped that patient’s payment burden in the country will be reduced and that increased access to factor VIII will enable Chinese haemophilia patients to receive more preventive treatment.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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Source: Clinical Trials.gov, SinoCellTech
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