Celltrion announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 4 clinical trial to secure evidence for the 240 mg high-dose administration of its subcutaneous formulation of infliximab, known as Jimpenetra (marketed as Remsima SC in the U.S.).
Unlike the traditional intravenous (IV) administration of infliximab, Jimpenetra is designed for patients to self-administer via subcutaneous injection. It has been approved in the U.S. for the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis.
The U.S. clinical trial will involve 447 patients with Crohn's disease (CD) and ulcerative colitis (UC) across 55 sites. The aim is to demonstrate the non-inferiority of the high-dose IV formulation of infliximab compared to the 240 mg dose of Jimpenetra, thereby obtaining objective clinical data necessary for future high-dose administration of Jimpenetra.
Celltrion plans to proactively secure reliable clinical data required for high-dose administration of Jimpenetra through this trial. This is expected to broaden the options for prescription dosages and provide optimal treatment alternatives tailored to patients' conditions and disease severity.
This clinical trial is being conducted to adapt the personalized prescription strategy of Remsima SC, which has been validated in the European market, to the U.S. market environment and maximize product competitiveness. Remsima SC has maintained a solid growth trajectory, achieving approximately 32% market share in the five major European countries (EU5) as of the first quarter of this year. In Europe, the high-dose prescription strategy tailored to patients' disease severity has driven rapid market share expansion.
Through this Phase 4 clinical trial in the U.S., Celltrion aims to establish a two-track prescription system for patients, incorporating the 240 mg high-dose data alongside the existing 120 mg dosage.
In addition to diversifying prescription dosages, Celltrion is also working on expanding indications to maximize the potential market size for Jimpenetra. The company is pursuing global clinical procedures to add rheumatoid arthritis (RA) as an additional indication, aiming to broaden the potential patient population for Jimpenetra.
By securing evidence for high-dose administration, Celltrion intends to further solidify the exclusive status of Jimpenetra, the world's only subcutaneous formulation of infliximab.
Meanwhile, the combined sales of Remsima SC and Jimpenetra in the first half of this year reached 456.2 billion won, raising expectations for annual sales to exceed 1 trillion won.
In the first half of this year, Remsima SC recorded sales of 356.7 billion won in global markets, including Europe and South Korea, while Jimpenetra achieved sales of 99.5 billion won in the U.S. The year-on-year growth rates were 20.3% and 176.4%, respectively.
Celltrion plans to cultivate the Remsima SC product line as its second product to achieve annual sales of 1 trillion won, following Remsima, by expanding prescriptions in existing markets, increasing supply in the second half, and entering new markets.
Unlike the traditional intravenous (IV) administration of infliximab, Jimpenetra is designed for patients to self-administer via subcutaneous injection. It has been approved in the U.S. for the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis.
The U.S. clinical trial will involve 447 patients with Crohn's disease (CD) and ulcerative colitis (UC) across 55 sites. The aim is to demonstrate the non-inferiority of the high-dose IV formulation of infliximab compared to the 240 mg dose of Jimpenetra, thereby obtaining objective clinical data necessary for future high-dose administration of Jimpenetra.
Celltrion plans to proactively secure reliable clinical data required for high-dose administration of Jimpenetra through this trial. This is expected to broaden the options for prescription dosages and provide optimal treatment alternatives tailored to patients' conditions and disease severity.
This clinical trial is being conducted to adapt the personalized prescription strategy of Remsima SC, which has been validated in the European market, to the U.S. market environment and maximize product competitiveness. Remsima SC has maintained a solid growth trajectory, achieving approximately 32% market share in the five major European countries (EU5) as of the first quarter of this year. In Europe, the high-dose prescription strategy tailored to patients' disease severity has driven rapid market share expansion.
Through this Phase 4 clinical trial in the U.S., Celltrion aims to establish a two-track prescription system for patients, incorporating the 240 mg high-dose data alongside the existing 120 mg dosage.
In addition to diversifying prescription dosages, Celltrion is also working on expanding indications to maximize the potential market size for Jimpenetra. The company is pursuing global clinical procedures to add rheumatoid arthritis (RA) as an additional indication, aiming to broaden the potential patient population for Jimpenetra.
By securing evidence for high-dose administration, Celltrion intends to further solidify the exclusive status of Jimpenetra, the world's only subcutaneous formulation of infliximab.
Meanwhile, the combined sales of Remsima SC and Jimpenetra in the first half of this year reached 456.2 billion won, raising expectations for annual sales to exceed 1 trillion won.
In the first half of this year, Remsima SC recorded sales of 356.7 billion won in global markets, including Europe and South Korea, while Jimpenetra achieved sales of 99.5 billion won in the U.S. The year-on-year growth rates were 20.3% and 176.4%, respectively.
Celltrion plans to cultivate the Remsima SC product line as its second product to achieve annual sales of 1 trillion won, following Remsima, by expanding prescriptions in existing markets, increasing supply in the second half, and entering new markets.
* This article has been translated by AI.
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