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2 clusters · 6 sources · 20 days · First seen · Last updated

Celltrion infliximab product market expansion

Overview

Celltrion has reported significant growth for its infliximab subcutaneous formulations, Remsima SC and Zymfentra. In the first half of the year, combined sales for these products reached 456.2 billion won. Remsima SC saw a 20.3% year-on-year increase, maintaining strong market shares in European countries such as Germany, France, and Italy. In the United States, Zymfentra sales rose by 176.4% compared to the previous year, totaling 99.5 billion won.

To build on this momentum, Celltrion has submitted an Investigational New Drug application to the U.S. FDA for a Phase 4 clinical trial of Zymfentra. This study aims to evaluate a high-dose 240mg administration for patients with Crohn’s disease and ulcerative colitis. By establishing a ‘two-track’ prescription system with both 120mg and 240mg doses, the company intends to diversify its U.S. market presence. Celltrion is also pursuing global clinical trials to expand Zymfentra’s indications to include rheumatoid arthritis.

Entities

Celltrion · Zymfentra · IQVIA · Remsima SC · United States

Timeline

  1. [BUSINESS] 3 sources
    Celltrion submits Phase 4 clinical trial plan for Zymfentra in the U.S

    Celltrion submitted a Phase 4 clinical trial plan to the FDA for its Zymfentra treatment, aiming to support 240mg high-dose prescriptions for autoimmune diseases in the U.S. market.

  2. [BUSINESS] 3 sources
    Celltrion Remsima SC and Zymfentra sales reach 456.2 billion won in H1

    Celltrion's Remsima SC and Zymfentra reached 456.2 billion won in H1 sales, driven by strong European market share and rapid growth in the U.S. market.

Sources

biotimes.co.kr · biz.heraldcorp.com · bosa.co.kr · newstomato.com · thebionews.net · tokenpost.kr