Celltrion will be Rani’s exclusive supplier of ustekinumab biosimilar, CT-P43, for oral RT-111 RaniPill™ program

SAN JOSE, CA, USA I January 09, 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 partnered with Celltrion for the development of RT-111, an orally administered ustekinumab biosimilar.

Under a license and supply agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance (CT-P43) required for RT-111. Rani is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial.

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. 

“We are delighted to be partnering with Celltrion, a leader in biosimilars and biologics manufacturing, on RT-111.  This agreement is a validation of our RaniPill oral drug delivery technology, which has already performed well in two separate Phase 1 trials of RT-101 and RT-102, respectively,” said Talat Imran, CEO of Rani.  “We value Celltrion as the exclusive provider of ustekinumab biosimilar for our RT-111 program and look forward to sharing the results of our study in due course, and potentially broadening our partnership with Celltrion.”  

“Celltrion strives to address unmet needs of patients and partnering with Rani offers the opportunity to replace painful injections with a pill,” said SungHyun Kim, Head of Medical Science Division. “Celltrion sees potential for the RaniPill platform to be applicable to other biologics.”

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™ capsules, which are 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™ capsules.  For more information, visit ranitherapeutics.com.

SOURCE: Rani Therapeutics