(Health Korea News / Lee Chung-man) As the schizophrenia treatment market shows growth, Hwanin Pharmaceutical is starting to develop additional risperidone preparations. As a result of this paper’s coverage, it was confirmed that Hwanin Pharmaceutical began recruiting participants for a bioequivalence test to evaluate ‘WIM-2301B’ on the 26th.
The test is to evaluate the bioequivalence of ‘WIM-2301B’ and ‘WIM-2301B-R’ in 56 healthy adults. It will be held at H Plus Yangji Hospital until February 10, 2025.
‘WIM-2301B’ was confirmed to be a generic version of Janssen Korea’s schizophrenia treatment ‘Risperdal’ (ingredient name: risperidone). ‘Risperdal’ is a mechanism for treating mental illness by acting on dopamine and serotonin receptors.
The U.S. Food and Drug Administration (FDA) first approved it as a treatment for schizophrenia in December 1993. In Korea, four doses (0.5 mg, 1 mg, 2 mg, and 3 mg) were approved by the Ministry of Food and Drug Safety in April 1996. Risperdal’s indications were later expanded to include the treatment of bipolar disorder and behavioral disorders related to central nervous system diseases.
Janssen Korea originally produced ‘Risperdal’ directly at its Hyangnam factory in Hwaseong-si, Gyeonggi-do. However, starting in the late 2010s, the company decided to withdraw from the plant in 2018 as it focused on high value-added medicines such as anticancer drugs and immunotherapies. Afterwards, existing manufactured items were withdrawn and permission was granted to replace them with imported items.
The Hyangnam factory left by Janssen Korea was acquired by Hwanin Pharmaceutical for 46 billion won, and through this, Janssen’s ‘Risperdal’ production facility was secured.
Coincidentally, this company focuses on the central nervous system (CNS) pharmaceutical business. In particular, as the schizophrenia treatment market continues to grow, Hwanin Pharmaceutical appears to be actively developing additional risperidone products such as ‘WIM-2301B’.
For reference, according to the National Health Insurance Corporation in 2018, the number of people receiving treatment for schizophrenia is increasing, albeit slightly, from 101,000 in 2012 to 108,000 in 2017.
Hwanin Pharmaceutical already has risperidone preparations. ‘Liperidone tablets’ (ingredient name: risperidone) 1mg, 0.5mg, and 3mg were approved in 2002, 2003, and 2007, respectively.
Nevertheless, the reason for developing additional risperidone preparations appears to be to secure items that the company does not have. Janssen’s ‘Risperdal’ comes in 0.5 mg, 1 mg, 2 mg, and 3 mg. Therefore, it appears that Hwanin Pharmaceutical will develop a 2mg dose through this bioequivalence test.
According to the Ministry of Food and Drug Safety, Hwanin Pharmaceutical’s ‘Liperidone Tablets’ 3 mg ranked first in risperidone preparation production performance in 2023 at KRW 5.5 billion. This was followed by Myungin Pharmaceutical’s ‘Lispen Tablet’ 3 mg at 4.9 billion won, followed by ‘Lispen Tablet’ 2 mg at 4.7 billion won. Although ‘Liperidone Tablets’ 3mg ranked first by a narrow margin, Myungin Pharmaceutical’s ‘Lispen Tablets’ 2mg is also achieving decent production results.
Therefore, it is expected that Hwanin Pharmaceutical will attempt to strengthen its competitiveness in the risperidone market by adding the previously insufficient 2mg dose.
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