Hanmi Pharmaceutical's Combination Drug for Dyslipidemia Treatment, 'Rosuzet': Confirmed Non-inferiority Efficacy and Safety Compared to Monotherapy in 'The Lancet' & 'European Heart Journal'

SEOUL,South Korea,March 17,2023 --Hanmi Pharmaceuticals (128940.KS),a subsidiary of Hanmi Science (008930.KS) in Korea,announced that the results of large-scale clinical trial with Rosuzet have been published in 'The Lancet' and the 'European Heart Journal'.

R&D-oriented pharmaceutical company,Hanmi Pharmaceutical's Rosuzet is a dyslipidemia medicine,is a single-pill combination of two different active ingredients: rosuvastatin and ezetimibe,and is a blockbuster product that records prescription sales in Korea of more than one hundred million dollars.

The result of a large randomized trial comparing Rosuzet and rosuvastatin monotherapy in 3,780 patients with arteriosclerotic cardiovascular disease (ASCVD) was published in The Lancet(IF 202.731) in August,2022. This study was named 'RACING'.

A sub-analysis of the diabetes mellitus (DM) cohort of the RACING study was published in the European Heart Journal(IF 35.855) in December,2022. This study evaluated the effect of moderate-intensity statin with ezetimibe combination therapy(Rosuzet) versus high-intensity statin monotherapy among 1398 patients with DM and ASCVD.

An official from Hanmi Pharmaceutical said,"We expect that Rosuzet's clinical trial results will be able to present new options in the treatment guidelines in this field at this time when dyslipidemia treatment is being progressing with high-intensity statin monotherapy around the world."

About RACING study; published in The Lancet

RACING study,3780 patients with documented ASCVD at 26 centers,including Severance Hospital,Cha University College of Medicine,and Korea University Anam Hospital,were randomly assigned to receive either Rosuzet (Rosuvastatin 10 mg/Ezetimibe 10 mg,n=1894) or high-intensity statin monotherapy (Rosuvastatin 20 mg,n=1886). The primary endpoint was the 3-year composite of cardiovascular death,major cardiovascular events,or non-fatal stroke,in the intention-to-treat population with a non-inferiority margin of 2.0%.

According to the results,the primary endpoint occurred in 172 patients (9.1%) in the Rosuzet group and 186 patients (9.9%) in the high-intensity statin monotherapy group (absolute difference -0.78%; 90% CI -2.39 to 0.83),demonstrating that Rosuzet is non-inferior to high-intensity statin monotherapy.

As for the key secondary endpoint,LDL cholesterol concentrations of less than 70 mg/dL at 1,2,and 3 years were observed in 73%,75%,and 72% of patients in Rosuzet group,and 55%,60%,and 58% of patients in the high-intensity statin monotherapy group (absolute difference 17.5% [95% CI 14.2–20.7] at 1 year; 14.9% [95% CI 11.6–18.2] at 2 years; 14.8% [95% CI 11.1–18.4] at 3 years; all p<0.0001). During the entire follow-up period,Rosuzet group showed a better LDL-C lowering effect than the high-intensity statin monotherapy group.

As a post-hoc analysis,LDL cholesterol concentrations of less than 55 mg/dL at 1,and 3 years were observed in 42%,45%,and 42% of patients in Rosuzet group and 25%,29%,and 25% of patients in the high-intensity statin monotherapy group,respectively.

In particular,this study means a lot in that it demonstrated the safety as well as the Non-inferiority efficacy of rosuvastatin and ezetimibe combination therapy. Discontinuation or dose reduction of study medication owing to adverse events or intolerance occurred in 88 patients (4.8%) in Rosuzet group and 150 patients (8.2%) in the high-intensity statin monotherapy group (p<0.0001).

About a study of RACING sub-anaysis; published in European Heart Journal

This study,published in the European Heart Journal,confirmed for the first time the Non-inferiority of combination therapy for DM patients with ASCVD,which had not been studied before. This subgroup analysis was led by Professors Kim Joong-sun and Lee Yong-jun of the Department of Cardiology at Severance Hospital at Yonsei University,and Professors Jae-Young Cho and Kyung-ho Yoon of the Cardiology Department of Wonkwang University.

The incidence of the primary outcome was similar between the two groups: 10.0% in Rosuzet group and 11.3% in the high-intensity statin monotherapy group (HR: 0.89; 95% CI: 0.64–1.22; P=0.460). In Rosuzet group,during the 3-year follow-up,the LDL-C target achievement rate (less than 70 mg/dL) was significantly higher than that in the high-intensity statin monotherapy group. It also showed a significantly high achievement rate of the LDL-C target level (less than 55 mg/dL) for very-high-risk patients recommended by the latest guidelines.

In particular,Rosuzet significantly reduced total cholesterol (TC) and triglyceride (TG) in compared to high-intensity statin monotherapy,and the intolerance-related discontinuation or dose reduction was significantly lower.

About Hanmi Pharmaceutical,Inc.

Hanmi Pharmaceutical,founded in 1973,is a R&D-oriented pharmaceutical bio company representing Korea. After the establishment by Pharmacist Lim Sung-ki,it was converted into a holding company system in 2010 and incorporated into a subsidiary of Hanmi Science. Hanmi Pharmaceutical invests more than 15% of its sales in R&D every year,and is in process of developing 26 candidate materials for innovative new drugs in three major fields; 1) Biologics: LAPSCOVERY platform applied long-acting pipeline; 2) NCE: Mainly oncology and auto-immune disease targeted pipelines; and 3) Fixed-dose combination programs. Among them,the new biological drug "Rolvedon" was approved for the treatment of neutropenia by U.S. FDA in 2022. In addition,Hanmi Pharmaceutical operates production facilities ranging from raw materials to chemicals and biopharmaceuticals and also has more than 5,000 employees in Korea,and China.

Official Website: www.hanmipharm.com