Celltrion's 'Jimpentra' in the US Market... Praised by Local Medical Professionals

Celltrion's new autoimmune disease treatment drug, Jimpendra (the US launch name for Remsima SC), made its debut in the US market last week with the goal of achieving 3 trillion KRW in sales next year and 5 trillion KRW by 2030. As key local medical opinion leaders (KOLs) have given positive evaluations of Jimpendra's clinical results, rapid market penetration is anticipated.

Screenshot of the webinar video on Jimpenetra by Professor Stephan Hanauer of Northwestern University, USA, published in Gastroenterology and Endoscopy News [Image source=Gastroenterology and Endoscopy News]

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According to industry sources on the 22nd, Professor Stephan Hanauer of Northwestern University's Feinberg School of Medicine in the US recently presented clinical results of Jimpendra during a webinar conducted with Gastroenterology and Endoscopy News. Professor Hanauer is recognized as an expert in inflammatory bowel disease in the US, having served as the principal investigator for the approval clinical trials of Remicade, the original drug containing infliximab, which is the main ingredient in both Jimpendra and Remsima.

During the webinar, Professor Hanauer explained, "Jimpendra demonstrated statistically superior efficacy compared to placebo in all primary endpoints, including clinical remission and endoscopic response rates, as well as all major secondary outcome measures." He added, "From a pharmacokinetic perspective, it maintained higher and more stable drug concentrations than the intravenous formulation." He also emphasized that "based on these results, Jimpendra was approved and launched in the US as a new drug, not as a biosimilar."

Infliximab is an ingredient used to treat various autoimmune diseases, including inflammatory bowel disease. It was first launched under the name Remicade in 1998 following approval clinical trials led by Professor Hanauer. Despite challenges from various similar agents, infliximab has maintained the number one market share in the US inflammatory bowel disease treatment market based on long-term efficacy and safety.

However, infliximab has faced repeated failures in developing a subcutaneous injection form, which patients can easily administer at home, despite high demand for such a formulation as an alternative to the intravenous form that requires hospital visits. Jimpendra has overcome these challenges and is the first and only infliximab-based drug successfully developed as a subcutaneous injection. The FDA also highly valued this during the approval consultation phase and recommended applying for approval as a new drug first.

This is why local medical professionals highly regard Jimpendra, with Professor Hanauer previously stating, "Jimpendra offers patients the option to maintain treatment at home." Professor Jean-Fr?d?ric Colombel of the Icahn School of Medicine at Mount Sinai in New York also commented, "Patients with inflammatory bowel disease prefer treatments that are safe, effective, and convenient to administer," adding, "This allows patients to manage their condition more flexibly and conveniently in daily life."

Professor Hanauer plans to conduct various webinars on Jimpendra in the future, including 'post hoc analyses of Jimpendra's clinical data' and 'real-world prescription data analysis of Jimpendra.'

Celltrion's new drug for autoimmune disease treatment, 'Jimpenetra'
[Photo by Celltrion]

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Meanwhile, Celltrion aims to make Jimpendra a global blockbuster product with over 10% prescription share in the US inflammatory bowel disease market by next year. The company is also making smooth progress in targeting pharmacy benefit managers (PBMs), which are considered the first gateway to the US market. PBMs negotiate drug prices and rebate levels with pharmaceutical companies on behalf of public and private insurers in the US and manage formularies, which are lists of drugs that can actually be prescribed. If a drug is not listed on a PBM formulary, it is virtually impossible to sell it in the US.

Jimpendra has already succeeded in being listed on formularies of various small to mid-sized PBMs, including Blue Cross Blue Shield (BCBS) Minnesota, from the time of its launch. BCBS operates systems by state, and Jimpendra was first listed in Minnesota. It is known that the total number of patients under BCBS's influence across the US reaches about 100 million. Notably, despite the usual intense negotiations after launch, these PBMs recognized Jimpendra's innovation and succeeded in listing it without separate negotiations.

In addition, Celltrion is continuing negotiations with major PBMs such as CVS Caremark, Express Scripts, and OptumRx, which collectively dominate about 80% of the US PBM market, aiming for preferred drug listing within the second quarter.

A Celltrion official said, "With Jimpendra's launch, interest from US physicians is rising, and negotiations with PBMs are progressing more positively. Jimpendra is a product with excellent competitiveness in treatment efficacy and dosing convenience. We will focus our company's capabilities on various marketing activities locally to quickly establish it in the market and ensure that more patients can benefit from Jimpendra's treatment."

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