(Health Korea News / Lee Chung-man) Yuhan Corporation is accelerating the development of ‘AD-228’, its candidate for a two-drug combination drug for hyperlipidemia. The competing drug is expected to be JW Pharmaceutical’s ‘Rivaroset’ (ingredient name: pitavastatin calcium hydrate + ezetimibe).
Addpharma, a subsidiary of Yuhan Corporation, received approval for the phase 1 clinical trial (IND) for ‘AD-228’ from the Ministry of Food and Drug Safety on the 10th. The test is to compare and evaluate the safety and pharmacokinetics of the combined administration of ‘AD-2281’ and ‘AD-2282’ and the single administration of ‘AD-228A’ in healthy adult volunteers.
Previously, Yuhan Corporation received approval for two phase 1 INDs for ‘AD-228’ through Addpharma in August and November 2024. The design of the clinical trial is to secure data through safety comparison and interaction exploration between single and combined drug administration. Among these, one is known to have already completed clinical trials.
According to Health Korea News coverage, ‘AD-228’ is a two-drug combination drug that combines JW Pharmaceutical’s ‘Rivaro Tablet’ (ingredient name: pitavastatin) and Korea Organon’s ‘Easytrol Tablet’ (ingredient name: ezetimibe). It was confirmed that
Pitavastatin, the main ingredient in ‘Livaro Tablet’, is known to have a significantly lower risk of side effects compared to other statin drugs. Among statin drugs, it is the only one that has been officially declared to have no negative effects on blood sugar in 32 countries, so confidence in its safety is high.
Another ingredient, ezetimibe (product name: ‘Easytrol Tablets’), is being widely adopted as an ingredient in statin-based hyperlipidemia combination drugs after its product patent expired in 2016. There are 669 statin + ezetimibe combination drugs approved by the Ministry of Food and Drug Safety.
However, there are not many pitavastatin + ezetimibe combination drugs currently on the market. JW Pharmaceutical’s ‘Rivaroset’ (ingredient name: pitavastatin calcium hydrate + ezetimibe) is a representative example. Since its launch in October 2021, this drug has immediately entered the blockbuster ranks, recording sales of 32.5 billion won in 2022 (company’s own calculations).
Accordingly, companies are targeting the ‘Liva Roset’ market through generic development. Five companies, including Anguk Pharmaceutical, filed a request for invalidation of the use patent for ‘Riva Roset’ in 2019, and received a ruling from the Intellectual Property Tribunal to establish the claim in April 2021, even before ‘Riva Roset’ was released. These drugs have been released one after another and are competing in the market with ‘Riva Roset’.
However, Yuhan Corporation is different in that it seeks to enter the market through the development of improved new drugs rather than generic drugs. This can be interpreted as an intention to secure differentiated competitiveness by ensuring the safety and effectiveness of ‘AD-228’ through multiple clinical trials as the technology is sufficient.
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