(Health Korea News / Lee Chang-yong) There is an outlook that Samjin Pharmaceutical’s antithrombotic drug ‘Plaaris (active ingredient clopidogrel)’ will overcome the wall of the traditional antithrombotic drug ‘aspirin (active ingredient salicylic acid)’. This was announced at the ‘HOST’ symposium held by Samjin Pharmaceutical at the Grand Hyatt Seoul in Yongsan-gu, Seoul from the 24th to the 25th of last month to commemorate the 17th anniversary of the launch of ‘Plaaris’. The symposium, which was organized to share the latest findings on clinical studies of ‘clopidogrel’, was a great success with over 100 cardiovascular specialists and practicing physicians from all over the country in attendance.
The first lecture of the symposium was given by Professor Ji-Hoon Kang of Seoul National University Hospital. Professor Kang explained ‘Long-term maintenance therapy for patients who received coronary artery stent therapy’ based on the results of ‘HOST-EXAM’ announced in LANCET in 2021 and the results of ‘HOST-EXAM extended’, a follow-up study announced in Circulation in 2023.
Professor Kang said, “As a result of long-term follow-up observation of 5,530 patients included in the HOST-EXAM study, clopidogrel showed superior results compared to aspirin in major indicators such as death, stroke, and bleeding,” and “It has been proven once again that ‘clopidogrel’ is the optimal option for long-term treatment of patients who have undergone coronary intervention.”
In addition to the existing clinical studies, Samjin Pharmaceutical is also conducting a new randomized controlled study, ‘HOST-PREVENTION’, with approximately 60 domestic institutions, centered around Seoul National University Hospital, starting in 2022. This clinical trial is interpreted as an attempt to secure sufficient clinical data for ‘Clopidogrel’ and overcome the stronghold of ‘Aspirin’.
The subjects of the ‘HOST-PREVENTION’ study are 10,034 patients with asymptomatic primary prevention patients with less than 50% stenosis of the coronary artery. As it is the largest study in Korea and the first of its kind in the world, interest is growing as the results may lead to changes in treatment guidelines.
The lecture that day also introduced the interim evaluation results of the ‘HOST-PREVENTION’ clinical study.
“Aspirin has been proven to be ineffective in elderly and diabetic patients”
Professor Han Jeong-gyu of Seoul National University Hospital, who gave the lecture, said, “The ASPREE, ASCEND, and ARRIVE studies announced overseas in 2018 proved that aspirin is ineffective in the elderly and diabetic patient group,” and “We hypothesized that clopidogrel could be an alternative as a primary preventive therapy for this patient group, and through the HOST-PREVENTION study, we have come to expect that the therapeutic area of clopidogrel will expand to primary preventive therapy.”
Professor Kim Hyo-soo of the Department of Cardiology at Seoul National University Hospital, who chaired the event that day, also predicted during the Q&A session after the lecture that “the era of clopidogrel will come in the primary prevention of coronary artery disease.”
Samjin Pharmaceutical’s antithrombotic drug ‘Flatless’ is a representative domestic ‘Clopidogrel Bisulfate’ formulation with 17 years of history this year, launched in January 2007. It is currently prescribed as a monotherapy or combination therapy (2-drug, 3-drug therapy) for cardiovascular, cerebrovascular, and peripheral arterial diseases, and is supplied to most general hospitals in Korea. The company explained that it has secured efficacy and formulation stability through strict quality control, such as allowing it to be used on patients who have received ‘Drug Eluting Stent (DES)’ based on clinical trials.
Samjin Pharmaceuticals succeeds in synthesizing ‘Flaless’ spherical particle raw material
Since the launch of ‘Flaris Tablets’ in 2007, Samjin Pharmaceutical has focused its company-wide efforts on research and development with the goal of developing it into a flagship prescription drug. As a result, in March 2009, two years after the product launch, it succeeded in synthesizing the raw material for ‘spherical particle (fine bead-shaped) clopidogrel bisulfate’ for the first time in Korea and obtained manufacturing and synthesis approval from the Ministry of Food and Drug Safety. The synthesis technology for ‘spherical particle clopidogrel bisulfate’ is so difficult that only one or two companies in the world possess it. Samjin Pharmaceutical is the only company in Korea that is producing it commercially in large quantities.
Samjin Pharmaceutical CEO Ji-hyun Choi told Health Korea News on the 6th, “I would like to express my gratitude for the great interest shown in the large-scale ‘HOST’ symposium held to commemorate the 17th anniversary of the launch of Samjin Pharmaceutical’s representative brand, the antithrombotic ‘Flatris Tablet.’” He added, “Samjin Pharmaceutical will do its best to ensure that ‘Flatris Tablet’ goes beyond being a leading product in the domestic market and becomes a new game changer in the global market through continuous quality control.”
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Source: www.hkn24.com
