(Health Korea News / Lee Chung-man) Yuhan Corporation is starting to develop an improved new drug for Hallym Pharmaceutical’s dyslipidemia combination drug ‘Staffen Capsule’ (ingredient name: pitavastatin + fenofibrate).
Yuhan Corporation received approval for the Phase 1 Clinical Trial (IND) for ‘AD-113’ from the Ministry of Food and Drug Safety on the 17th. The test is to evaluate the safety and pharmacokinetics of ‘AD-113’ and ‘AD-113A’ when administered orally in a postprandial state to healthy adult volunteers.
As a result of this paper’s coverage, it was confirmed that ‘AD-113’ is a combination drug combining pitavastatin and fenofibrate, which are used to treat dyslipidemia. This is the same as Hallym Pharmaceutical’s dyslipidemia treatment ‘Staffen Capsule’.
Statin drugs, including pitavastatin, are drugs that lower cholesterol by inhibiting HMG-CoA reductase, an enzyme that promotes the reaction rate of the cholesterol biosynthesis pathway, and are the most commonly used drugs for dyslipidemia. Drugs whose names end in -statin are called statin drugs.
Fenofibrate is a mechanism that amplifies the lipolysis effect by inducing the activity of PPAR-alpha factor, which reduces the function of apolipoprotein C-III (a protein that inhibits the action of lipolytic enzymes) and lowers the level of triglycerides in the blood.
Accordingly, the pitavastatin + fenofibrate combination drug can treat dyslipidemia more effectively through different mechanisms.
The first pitavastatin + fenofibrate combination drug to appear was Hallym Pharmaceutical’s ‘Stafen Capsule’. In April 2019, Hallym Pharmaceutical obtained approval for ‘Stafen Capsule’ and the twin drugs from the Ministry of Food and Drug Safety along with seven consignees, including Daewon Pharmaceutical and Anguk Pharmaceutical. All eight items are produced at Hallym Pharmaceutical’s first factory in Yongin.
‘Staffen Capsule’ and its twin drugs began to attract the attention of pharmaceutical companies, posting remarkable sales after their launch. According to the Ministry of Food and Drug Safety, the market size of pitavastatin + fenofibrate preparations in 2022 reached 34.5 billion won.
However, since ‘Staffen Capsule’ does not currently have a registered patent, competing companies can easily develop replicas (generics) if they want to.
In fact, Shinpoong Pharmaceutical received biosimilar IND approval from the Ministry of Food and Drug Safety in November 2023, and Seoul Pharmaceutical and Dasan Pharmaceutical in May and June of this year, respectively.
On the other hand, Korea United Pharmaceutical and Yuhan Corporation are attempting to enter the market with improved new drugs.
First, the pitavastatin + fenofibrate combination drug ‘UI100’ being developed by United Pharmaceutical Korea is a drug whose dosage form has been changed from the hard capsule-granule tablet (immediate-release) of the existing ‘Staffen Capsule’ to an enteric capsule-tablet (sustained-release).
In the case of Yuhan Corporation, the dosage form of ‘AD-113’ was decided to be a film-coated tablet. This formulation consists of tablets coated with a thin film. Films are mainly used to mask the taste of tablets, improve the convenience of taking and the characteristics of tablets.
Capsules have the advantage of controlling drug release. However, the downside is that it is difficult to control the size of the drug and the manufacturing cost is higher than tablets. In contrast, tablets allow for easy control of the size of the drug and provide significant cost savings in terms of mass production.
Among pitavastatin + fenofibrate combination drugs currently approved or under development, ‘AD-113’ is the first film-coated tablet. Therefore, if commercialized, it is expected to have differentiated competitiveness in the market.
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