JW Pharmaceutical, "Commercialization of Severity Testing for Hemlibra Patients"

Chromogenic Substrate Assay Newly Classified as a Non-Reimbursable Item Under Health Insurance

JW Pharmaceutical announced on the 15th that the chromogenic substrate assay (CSA test), which can evaluate the severity of hemophilia in patients treated with the type A hemophilia treatment 'Hemlibra,' has been commercialized.

The Ministry of Health and Welfare recently established the CSA test as a non-reimbursable item under health insurance, which has been applied since the 1st of this month.

The CSA test measures the activity of coagulation factors in hemophilia patients to diagnose the severity of the disease and monitor treatment effectiveness. In particular, it can precisely measure the activity of factor VIII, which is deficient in type A hemophilia patients, and JW Pharmaceutical explained that it is also suitable for patients using non-factor therapies such as Hemlibra.

Hemlibra is an innovative drug that mimics the blood coagulation factor VIII, which is deficient in patients with type A hemophilia. It is the only type A hemophilia treatment that can be used for both patients with antibodies resistant to conventional treatments (factor VIII products) and those without antibodies. It also features a preventive effect that lasts with a subcutaneous injection once every four weeks at most.

Until now, the one-stage clotting assay (OSA test), mainly used in Korea, had limitations such as low diagnostic accuracy for mild patients and difficulty in confirming the severity in patients treated with Hemlibra. Therefore, the World Federation of Hemophilia (WFH) recommends using both OSA and CSA tests together and suggests the CSA test for assessing hemophilia severity in patients receiving Hemlibra and for hemostatic function testing after combined factor VIII administration.

Professor Park Young-sil of the Department of Pediatrics at Kangdong Kyung Hee University Hospital stated, "With the commercialization of the CSA test, it has become possible to evaluate the severity of hemophilia in patients treated with Hemlibra," and added, "The diagnostic environment for mild patients and female hemophilia patients (carriers), who could not be accurately diagnosed with only the existing OSA test, will also improve."

A representative of JW Pharmaceutical said, "The commercialization of the CSA test will greatly contribute to the advancement of hemophilia diagnosis and treatment," and added, "We will continue to do our best to improve treatment accessibility and quality of life for patients with type A hemophilia."