Celltrion’s headquarters in Songdo, Incheon (The Korea Herald)
South Korean pharmaceutical giant Celltrion is preparing to launch an overseas clinical trial for a new medicine for hypertrophic cardiomyopathy, according to industry sources Monday.
Celltrion is currently recruiting participants in Poland for its phase 1 clinical trial for CT-G20, the South Korean biopharmaceutical company’s first-ever chemical drug for HCM, a heart disease for which there is currently no known cure.
The firm plans to submit an investigational new drug application to the US Food and Drug Administration during the first half this year to start conducting the trials in the US as well.
Celltrion has currently secured three medical institutions in the US for the clinical study, according to the company.
CT-G20 is in the phase 1 clinical trial stage in South Korea, which the company expects to wrap up during the first half of this year.
Celltrion’s plan is to complete the phase 3 study by the end of 2022 and begin commercial production in 2023.
HCM is a disease in which a portion of the heart’s muscle becomes abnormally thick, making it harder for the heart to pump blood.
Symptoms of HCM include chest pain, dizziness, fainting or cardiac arrest in severe cases. Patients who suffer from the condition usually take anti-hypertensive or anti-arrhythmic drugs as alternatives in order to ease the symptoms.
There are an estimated 650,000 HCM patients in the United States, among which some 120,000 are on medication to help alleviate symptoms.
Celltrion previously estimated that the US alone would be a market worth 3 trillion won ($2.65 billion) per year for CT-G20.
By Shim Woo-hyun (firstname.lastname@example.org