Celltrion Group Begins Development of Oral Infliximab with UK Biotech Company

[Asia Economy Reporter Cho Hyun-ui] Celltrion and Celltrion Healthcare, part of the Celltrion Group, announced on the 20th that they have signed a Joint Development Agreement (JDA) with UK biotech company Intract Pharma to develop an oral pill form of infliximab. If commercialization is successful through this joint development, it will be the first pill-form product containing infliximab to be introduced to the market.

Infliximab is the main ingredient of Celltrion's flagship biosimilar for autoimmune disease treatment, 'Remsima.'

The Celltrion Group will supply infliximab as a clinical trial raw material to Intract Pharma. Intract Pharma will be responsible for developing and validating the oral form of infliximab based on its oral formulation technology that efficiently delivers protein drugs such as antibodies to the intestines.

The Celltrion Group has secured rights such as the first negotiation priority upon completion of Phase 2 clinical trials and the right to receive a portion of sales as royalties upon technology export. Even if Intract Pharma or a third party that has acquired the technology succeeds in commercialization, the Celltrion Group will exclusively supply infliximab for commercial material production.

Intract Pharma, responsible for development, has been exempted from non-clinical and Phase 1 clinical trials by the UK Medicines and Healthcare products Regulatory Agency (MHRA). They plan to start Phase 1b/2a clinical trials targeting patients with inflammatory bowel disease (IBD) in the second half of next year.

A Celltrion official said, "Based on our experience successfully commercializing Remsima, the world's first intravenous form, and developing RemsimaSC, the first subcutaneous injection formulation, we have begun developing oral infliximab so that the Remsima brand can be presented to the medical community with various options."

This content was produced with the assistance of AI translation services.