Celltrion's 'Jimpentra' Launching in the US Next Month... Local Medical Staff Also Anticipate

Celltrion's autoimmune disease new drug 'Zimpenetra (generic name: infliximab)', aiming for '5 trillion KRW in sales by 2030', will be launched in the United States next month. As initial market dominance emerges as a key factor, an interview with major local U.S. medical professionals (KOLs) who have high expectations for the launch of Zimpenetra has been released.

Stephan Hanauer, Professor at Feinberg School of Medicine, Northwestern University, Chicago, USA

Stefan Hanauer, professor at Northwestern University's Feinberg School of Medicine in Chicago, recently explained in a foreign media interview, "Zimpenetra gives patients the option to maintain treatment at home," adding, "Phase 3 clinical trials confirmed that the infliximab subcutaneous (SC) formulation maintains drug concentration better." Professor Hanauer participated as the principal investigator in the approval clinical trials of the original infliximab drug 'Remicade' and serves as an advisory board member for Zimpenetra's new drug approval clinical trials. He is regarded as an expert in inflammatory bowel disease (IBD) in the U.S.

Zimpenetra is the first infliximab SC formulation drug. Infliximab is a tumor necrosis factor (TNF)-α inhibitor used to treat various autoimmune diseases, including Crohn's disease and ulcerative colitis, which are types of IBD. Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen) first developed it under the name Remicade and received FDA approval in 1998 as a treatment for Crohn's disease in the U.S. Since then, various TNF-α inhibitors have been launched over 26 years, but infliximab still holds the number one market share in the U.S. IBD market based on long-term efficacy and safety. However, due to repeated failures in developing more convenient SC formulations, it is still only used in the initial intravenous (IV) form, leaving a significant unmet need for formulation development.

This is why Zimpenetra, an infliximab SC formulation that even the original developer J&J could not develop, is receiving high expectations. Although Zimpenetra is a biosimilar and not a newly developed ingredient, the FDA highly valued the possibility of formulation change and even encouraged an early new drug approval application. Professor Hanauer explained that thanks to this convenience, Zimpenetra "provides flexibility" to patients and "offers the option of maintenance treatment at home for both patient groups who prefer IV and SC formulations."

Celltrion's new autoimmune disease treatment drug 'Jimventra' (right).

Regarding efficacy, it was explained that Zimpenetra shows no difference or even better efficacy while confirming favorable safety. In clinical trials, Zimpenetra received good evaluations in pharmacokinetics (PK) aspects such as clinical remission and endoscopic response rates, in addition to high convenience. Professor Hanauer stated, "The SC formulation was confirmed to maintain blood drug concentration better," adding, "No unexpected side effects or toxicity were found compared to placebo-treated patients, so it is reassuring." For IBD, maintaining an appropriate drug concentration continuously is important to achieve therapeutic effects. However, the existing IV formulation has an 8-week dosing interval, which raises concerns that drug concentration may fall below the appropriate level just before re-dosing. In contrast, Zimpenetra is administered every two weeks, allowing stable maintenance of drug concentration, which is expected to improve not only patient convenience but also actual drug efficacy.

Celltrion expects Zimpenetra to leverage these advantages to achieve about 600 billion KRW in sales by the end of this year after its launch next month. Considering that the IBD market targeted by Zimpenetra is worth $9.827 billion annually (approximately 13 trillion KRW), this is interpreted as aiming to capture about 5% of the market share. In the European market where it is already marketed, the combined market share of the existing IV formulation 'Remsima' and Zimpenetra exceeds 60% in the five major countries, and in the U.S. market, patent protection lasts until 2038, allowing stable revenue without competition.

The first hurdle Zimpenetra must overcome after launch is the Pharmacy Benefit Manager (PBM). For self-administered drugs like Zimpenetra in SC formulation, the drug must be listed on formularies selected by PBMs acting on behalf of insurers in the U.S. for actual distribution and sales to be possible. Previously, the autoimmune disease treatment biosimilar 'Uplima' faced concerns due to delayed PBM listing after its launch in July last year, but it is now listed on major PBMs such as Optum and Vantage. A Celltrion official stated, "We are conducting prior consultations aiming for rapid PBM listing," adding, "We are establishing a direct sales system and deploying a large number of professionals to secure profitability through optimal pricing by leveraging the new drug position."