On 4 March 2026, CSPC Pharmaceutical Group announced that it has received approval from China’s National Medical Products Administration (NMPA) to begin clinical trials of its emicizumab injection (SYS6053), a biosimilar to Roche’s Hemlibra® (emicizumab), for the treatment of Haemophilia A. According to CSPC, the product, which is a modified bispecific humanised monoclonal antibody, has been demonstrated to be highly similar to Hemlibra® in terms of quality, safety and efficacy in pharmaceutical and non-clinical studies. Emicizumab is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with Haemophilia A, with or without factor VIII inhibitors. Hemlibra® was first approved by the US FDA in November 2017, followed by marketing authorisation from the EMA in February 2018.
CSPC Pharmaceutical Group is a Hong Kong-incorporated pharmaceutical company who has a growing biosimilar portfolio; in August 2025, CSPC received NMPA approval to conduct clinical trials of its biosimilar dupilumab injection (biosimilar to Sanofi/Regeneron’s Dupixent®), and in November 2024, its biologic licence application for biosimilar ustekinumab was accepted by the NMPA.
Biosimilar development of emicizumab is at a very early stage globally. There are currently no approved emicizumab biosimilars in any major market. Prestige BioPharma has a preclinical emicizumab biosimilar candidate in development. The development of biosimilars for emicizumab presents unique challenges due to its bispecific monoclonal antibody structure, which is more complex than traditional monoclonal antibodies. The patent for Hemlibra® is expected to expire around 2032. In September 2025, the World Health Organisation (WHO) updated its Model List of Essential Medicines to include emicizumab for Haemophilia A, a development which may help to stimulate further investment in emicizumab biosimilar development. CSPC’s clinical trial approval for SYS6053 appears to position it among the first companies globally to advance an emicizumab biosimilar into clinical development.