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Rani Strengthens Partnership with Celltrion to Develop Adalimumab (Humira) Biosimilar

The collaboration will focus on RT-105, an orally administered biosimilar for adalimumab, an anti-inflammatory monoclonal antibody used to treat autoimmune diseases.

Novel drug delivery-focused biotech Rani Therapeutics has stated that it is extending its partnership with Korean biopharma company Celltrion to develop a further biosimilar. The deal includes manufacture, supply, and commercialisation rights, and provisions for after a phase 1 clinical trial of the drug.

Rani Therapeutics and Celltrion are already in an existing partnership to develop RT-111: an orally administered biosimilar for the monoclonal antibody ustekinumab. Now they will work together to develop an additional biosimilar: RT-105, an orally administered biosimilar for adalimumab.


“We are delighted to expand our partnership with Celltrion, a world-class pharmaceutical company, a leader in biosimilars and our valued partner,” said Talat Imran, CEO of Rani Therapeutics.

Adalimumab, sold under the brand-name Humira, is an anti-inflammatory monoclonal antibody therapy used to treat various autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease, among others.

Under the terms of the extended partnership, Celltrion will solely supply CT-P17, a necessary component of the RT-105 biosimilar formulation. Rani will in return be able to exclusively develop and commercialise RT-105. Furthermore, following a phase 1 clinical trial of the therapy, Celltrion will be offered the right of first negotiation to acquire its worldwide rights.

This collaboration will be the first to utilise Rani Therapeutics’s RaniPill HC technology: a high capacity version of their novel oral delivery platform. RaniPill is a drug delivery device that  aims to deliver almost any biologic orally.


    The platform is intended to replace subcutaneous and intravenous injection, all while maintaining the bioavailability of injectables. RaniPill uses a unique device inside a dissolvable capsule that is able to inject a patient from within the intestine.

    “We believe this expansion of the Rani-Celltrion relationship further validates our RaniPill platform and offers the potential to deliver great value for both our companies. We look forward to advancing both RT-105 and RT-111 as oral alternatives to painful injections for people with chronic inflammatory conditions,” Imran further added.

    In this deal, Rani will aim to use their platform for the delivery of the TNF-? antibody. SungHyun Kim, Head of the Medical Science Division at Celltrion, said:

    “We are pleased to build upon our existing partnership with Rani, a company that is pioneering oral drug delivery across a broad range of injectable therapeutics. The cooperation between our companies allows each of us to pursue our commitment to delivering effective and convenient medicines, which in time could benefit healthcare systems, providers, and patients.”

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