Chong Kun Dang also enters low-intensity atorvastatin mkt

Following Yuhan Corp

Lipilou 5mg is approved… none are listed for reimbursement yet

Amid fierce competition in the hyperlipidemia drug market to develop 2nd generation ‘statin + ezetimibe’ combination drugs using low-strength statins, some low-dose atorvastatin products are also soon to enter the market.

 

On the 12th, the MFDS approved Chong Kun Dang's ‘Lipilou Tab 5mg.’ It is a 5 mg low-strength single tablet that contains atorvastatin calcium trihydrate.

 

This is the second single low-dose atorvastatin drug to be approved after Yuhan Corp’s 'Atorvastatin 5mg' in May last year.

 

Chong Kun Dang owns 3 ‘Lipilouzet Tab’ combination drugs that contain atorvastatin and ezetimibe.

 

The three contain the same dose of ezetimibe of 10 mg, with different doses of atorvastatin of 10mg, 20mg, and 40 mg.

 

The company also owns monotherapy atorvastatin in 10mg, 20mg, 40mg, and 80mg doses as ‘Lipilou Tab,’ and the lineup has been extended with the addition of the 5mg formulation.

 

With the approval of the low-strength monotherapy drug, Chong Kun Dang is expected to also develop a combination drug using the 5 mg atorvastatin and expand its Lipilouzet lineup.

 

In Korea, the development of the low-dose statin-based hyperlipidemia combination drug was pioneered by Hanmi Pharmaceutical.

 

In September 2021, Hanmi Pharmaceutical received approval for ‘Rosuzet Tab 10/2.5mg,’ a combination of rosuvastatin 2.5 mg and ezetimibe.

 

After being released in October of the same year with reimbursement, the drug’s sales have been rapidly increasing in the market.

 

According to the market research institution UBIST, outpatient prescriptions for Rosuzet in 2022 reached KRW 140.3 billion, up 14% year-on-year.

 

The rising demand for low-dose rosuvastatin has prompted other companies to develop combination products based on low-dose rosuvastatin.

 

Following Daewoong Pharmaceutical's approval of Crezet Tab 10/2.5 mg, which contains the same ingredient-dose combination as Rosuzet in August 2022, Yuhan Corp released ‘Rosuvamibe,’ HK Inno.N ‘Rovazet,’ and GC Biopharma ‘Daviduo’ in their product lineup.

 

Yuhan Corp then introduced a low-dose(5 mg) atorvastatin product, continuing the low-dose boom in hyperlipidemia treatment that began with rosuvastatin.

 

To date, no 5 mg low-dose atorvastatin calcium trihydrate has been granted reimbursement in Korea.

 

With Yuhan Corp having established a foothold in the hyperlipidemia market, the addition of Chong Kun Dang’s product is expected to open up the low-dose atorvastatin market shortly.