■ Our response to our shareholders’ inquiries about U.S. President Biden’s “Executive Order to launch a National Biotechnology and Biomanufacturing Initiative” are as follows:
■ After a thorough review of the Executive Order, we view it would have little, if any, impact on Celltrion Group.
■ Celltrion Group brings mostly in-house developed antibody products to market, and the CMO business takes an insignificant portion of the business, unlike the concerns of some experts and media.
■ Any products launched in the US after 2023 will be directly sold by a U.S. legal entity of Celltrion Healthcare.
■ While Celltrion Group has secured several manufacturing sites home and abroad for the production of API and finished products, Celltrion Group will be actively considering options for obtaining manufacturing sites in the US if it is deemed to be beneficial to Celltrion Group after a thorough review of policies including incentives on investments in the US.
We have been contributing to the improvement of patient welfare and access to healthcare by offering innovative biologics to the world.
BUSINESSWe are exerting efforts to achieve sustainable growth.
Celltrion Healthcare will shape a healthier and happier future for humanity by offering high-quality biologics.
Celltrion Healthcare offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets of the United States and Europe, Celltrion Healthcare has been securing distribution channels and providing patients with biosimilars at affordable prices.
Remsima® is a biosimilar infliximab approved by the European Medicines Agency (EMA) in August 2013 and the U.S. Food and Drug Administration (FDA) in April 2016. It is indicated for the treatment of Rheumatoid Arthritis(RA), Ankylosing Spondylitis(AS), Ulcerative Colitis(UC), Crohn’s disease(CD), Psoriatic Arthritis(PsA), and Psoriasis.
Truxima® is a biosimilar rituximab approved by the European Medicines Agency (EMA) in February 2017 and the U.S. Food and Drug Administration (FDA) in November 2018. It is indicated for the treatment of Non-Hodgkin's Lymphoma(NHL), Chronic Lymphocytic Leukemia(CLL), and Rheumatoid Arthritis(RA).
Herzuma® is a biosimilar trastuzumab approved by the European Medicines Agency (EMA) in February 2018 and the U.S. Food and Drug Administration (FDA) in December 2018. It is indicated for the treatment of HER2-Positive Metastatic Breast Cancer, Early Breast Cancer(EBC), and Metastatic Gastric Cancer(MGC).
Remsima®SC is a SC formulation of biosimilar infliximab approved by the European Medicines Agency (EMA) in November 2019. It is indicated for the treatment of Rheumatoid Arthritis(RA), Crohn’s disease(CD), Ulcerative Colitis(UC), Ankylosing Spondylitis(AS), Psoriatic Arthritis(PsA), Psoriasis in adult patients.
Celltrion Healthcare has become the world’s leading company that specializes in biologics by offering high-quality biosimilars to about 110 countries, with the ultimate goal of promoting the welfare of humanity.