GC jumps into low-dose rosuvastatin compound market

Amid the increasing trend among Korean pharmaceutical companies to release compound drugs to treat chronic diseases, GC Biopharma has jumped into the prescription market by winning approval for its low-dose rosuvastatin compound treatment.

In a public filing on Tuesday, GC Biopharma said it had won a regulatory nod for Daviduo Tablet 10/2.5mg, a treatment for dyslipidemia, from the Ministry of Food and Drug Safety.

The approval came nearly three months after the company submitted an application on Dec. 12.

Daviduo Tab is a two-drug compound of ezetimibe, an ingredient to treat dyslipidemia, and rosuvastatin calcium. The drug has set itself apart from existing dyslipidemia compounds by lowering its doses.

Addpharma, a subsidiary of Yuhan Corp., developed the drug and conducted its clinical trials. GC Biopharma signed a three-way manufacturing consignment contract with Yuhan and Addpharma.

Under the contract, Yuhan will manufacture the quantity ordered by GC Biopharma, which will pay the cost to its commissioned manufacturer.

GC Biopharma said in the public disclosure that it planned to release Daviduo Tab before the end of this year.

The competition to prescribe low-dose rosuvastatin compounds will likely intensify, as the Korean Society of Lipidology and Atherosclerosis recommended lowering LDL-C treatment targets for different patient groups in its revised treatment guideline in September last year compared to its previous guideline released in 2018.

Hanmi Pharm and Daewoong Pharmaceutical have already released low-dose rosuvastatin compounds in the prescription market.

In December 2021, Hanmi took the initiative by releasing Rosuzet 10/2.5mg (751 won per tablet). Daeweeong followed soon by marketing Crezet 10/2.5mg (750 won per tablet) for two months in November of last year. GC Biopharma’s entry will likely turn it into a three-way market battle.

These companies expect low-dose rosuvastatin compounds to minimize risks of side effects caused by high-dose statins, such as diabetes and myopathic disorders.

“In keeping with the revised treatment guidelines, the need to secure statin-ezetimibe compounds has increased. As a result, the competition will likely follow to preempt this market,” an industry executive said.