Celltrion said on Monday that it signed an agreement with U.S.-based biotech, Rani Therapeutics, to develop an oral formulation of RT-105 (ingredient: adalimumab), a treatment for autoimmune diseases.

Accordingly, Celltrion will exclusively supply Rani with an oral adalimumab formulation and will have a right of first refusal to negotiate a global license based on future phase 1 results. Meanwhile, Rani will conduct clinical trials on its proprietary technology for high-dose drug delivery and develop high-concentration oral adalimumab.

This collaboration follows Celltrion's previous agreement with Rani in early January to develop an oral formulation of RT-111 (ustekinumab).

RaniPill is the company's proprietary oral capsule platform technology that enables the oral delivery of proteins and antibodies that have previously only been available in intravenous or subcutaneous formulations.

As RaniPill has already demonstrated similar bioavailability to subcutaneous formulations, this collaboration is expected to help Celltrion differentiate itself in the increasingly competitive adalimumab market, which is centered on high-concentration formulations.

Upon completion of product development, Celltrion expects to have a significant impact on the estimated $28 trillion adalimumab market by providing patients with the existing original drug's efficacy and convenience .

CT-P17's original drug, Humira, is a blockbuster autoimmune disease treatment made by AbbVie that generated sales of about $21.37 billion last year. The U.S. market alone accounted for more than 87 percent of global sales of approximately $18.619 billion.

“We completed the development of CT-P17 and received marketing authorization from the European EMA for the world's first high-concentration formulation, which was recently approved by the FDA.” said an official from Celltrion. " We are actively aiming to diversify our treatment modalities with differentiated formulations by entering into oral drug development collaboration for CT-P43 (ustekinumab) and CT-P17 (adalimumab).