News | May 27, 2024

Henlius Rituximab Receives Marketing Approval In Peru

  • The 3rd self-developed and -manufactured product breaking into global markets
  • HANLIKANG’s first approval beyond China to benefit patients in emerging markets
  • The 1st biosimilar launched in China, benefiting over 250,000 Chinese patients since 2019

Recently, HANLIKANG (rituximab), independently developed and manufactured by Henlius, has been approved to be marketed in Peru under the trade name AUDEXA by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). HANLIKANG is the third product that has been developed and manufactured by Henlius independently and approved for overseas marketing, following HANQUYOU and HANSIZHUANG. As China's first biosimilar, HANLIKANG has so far benefited over 250,000 Chinese patients since its launch in 2019.

The approval of HANLIKANG by DIGEMID in Peru is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China’s National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANLIKANG and the reference product, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANLIKANG and the reference product are highly similar in terms of quality, safety and efficacy.

HANLIKANG’s development, manufacturing and the quality management system are in line with global standards. Xuhui Facility, the manufacturing facility for HANLIKANG, has obtained Good Manufacturing Practice (GMP) certifications from both China and the EU, making it the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners.

Henlius has aggressively pursued international commercialisation of HANLIKANG, actively collaborating with global partners such as Abbott, Boston Oncology, Eurofarma and FARMA DE COLOMBIA to bring its therapeutics to patients around the world. In keeping with the original aspirations of “affordable innovation and reliable quality”, Henlius will continue to promote the approval and launch of HANLIKANG in more countries and regions to accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.

Source: Shanghai Henlius Biotech, Inc.