Celltrion, a leading biopharmaceutical company in South Korea, has partnered with Rani Therapeutics, a US-based clinical-stage biotech company. According to Yonhap, under their new partnership, they will jointly develop ‘oral adalimumab’ which is an oral autoimmune disease treatment with the development name RT-105.
Celltrion has previously developed the CT-P17 (adalimumab), a biosimilar of Humira. This prevalent autoimmune disease medication for rheumatoid arthritis, spondyloarthritis, and psoriasis has obtained marketing permission from the European Medicines Agency (EMA), an Amsterdam-based agency responsible for the evaluation and supervision of pharmaceutical products in European countries and approval of USA’s Food and Drug Administration (FDA), a federal agency of health.
The new partnership also aims to transform the injectable CT-P17 into an oral pill version, RT-105. Rani Therapeutics specializes in developing technology for the oral delivery of biological drugs and enhancing patient recovery. They will assist in converting protein and antibody formulations into oral formulations.
As per the terms and conditions, Celltrion has the responsibility to provide CT-P17 for the development of RT-105. It also has the first option to purchase global development. It furthermore has the opportunity to commercialize the rights depending on the first phases’ outcomes.
This collaboration builds upon a previous agreement between the two companies in January of this year for the development of an oral formulation of RT-111, an oral monoclonal antibody treatment. The Humira market, currently valued at $28 trillion, anticipates significant changes brought by Celltrion.
Celltrion’s Yuflyma receives FDA approval
In March this year, the US approved Celltrion-made Yuflyma, a citrate-free formulation of Humira biosimilar. Yuflyma offers an alternative treatment option for patients. In the US, about 80 percent of patients treated with Humira are dependent on high-concentration as well as citrate-free formulations like Yuflyma.
In the USA, Humira is widely utilized as a treatment for autoimmune diseases. It generated global sales of approximately $21.37 billion in 2022. The US market accounts for over 85 percent of global sales, amounting to $18.6 billion. The intake of Humira is therefore the highest in the world.
Celltrion is also actively seeking collaborations with domestic and international biotech firms. The company additionally is committed to innovation. It plans to expand treatment modalities with specific formulations in the coming months, according to a representative from Celltrion.