Rani Therapeutics and Celltrion Expand Partnership to Include Adalimumab Biosimilar for RT-105

2023-06-06

引进/卖出临床1期

This is the second deal announced between Rani and Celltrion, building upon a previously announced partnership for ustekinumab biosimilar for RT-111

SAN JOSE, CA, USA I June 05, 2023 I Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it has expanded its partnership with Celltrion by entering into an agreement for the development of RT-105, an orally administered adalimumab biosimilar. Rani’s first partnership with Celltrion, for the development of RT-111, an orally administered ustekinumab biosimilar, was announced in January of this year.

Under the terms of the new license and supply agreement, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for RT-105. Rani is granted an exclusive license to use CT-P17 in the development and commercialization of RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-105 following a Phase 1 study.

“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. “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.”

Rani has developed an oral delivery technology known as the RaniPill® capsule, which is intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing. The RaniPill® capsule is designed to administer biologics and drugs with bioavailability comparable to subcutaneous injection.

The RaniPill® platform is payload-agnostic and has the potential to create an oral option for almost any biologic or drug, regardless of modality or therapeutic area. In this agreement with Celltrion, Rani is applying its oral delivery technology to a TNF- α antibody for the potential treatment of inflammatory diseases.

“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,” said SungHyun Kim, Head of Medical Science Division. "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.”

This is the first announced partnership for a program involving the RaniPill® HC, a high-capacity device that is designed to deliver up to 20mg of payload with high bioavailability and is in preclinical testing.

About Rani Therapeutics

Rani Therapeutics is a clinical stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill® capsule technology. For more information, visit www.ranitherapeutics.com.

SOURCE: Rani Therapeutics

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