Korean pharmaceuticals such as SK Biopharmaceuticals, CMG Pharmaceutical, and Bukwang Pharm are entering a therapy field long dominated by multinational pharma - drugs for schizophrenia and bipolar disorder.

According to industry sources, the three pharmaceuticals are pushing to commercialize new drugs or put incrementally modified medications on the market.

Schizophrenia is a mental disorder that affects how a person thinks, feels, and behaves and is characterized by false beliefs, unclear or confused thinking, hearing voices, and reduced social engagement and emotional expression, among others. Bipolar disorder is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks, according to the National Institute of Mental Health.

SK Biopharmaceuticals has been researching its investigational drug for schizophrenia dubbed SKL20540 with funding from the Korea Drug Development Fund, according to reports. The firm received the Ministry of Food and Drug Safety’s go-ahead in January to test the therapy.

“We are currently in a phase 1 trial for SKL20540 and aim to start phase 2 trials for the drug by 2020,” an SK Biopharmaceuticals official said.

CMG Pharmaceuticals, an affiliate of Cha Health Systems, is developing an oral thin film (OTF) version of Abilify (ingredient: aripiprazole), a blockbuster drug developed by Otsuka Pharmaceutical and Bristol-Myers Squibb. The Korean pharmaceutical said it’s applying for U.S. FDA approval for the OTF version in 2018, according to local sources.

OTF is a tiny film that differs substantially from tablets and capsules and does away with the need for water or injections. Abilify OTF makes it convenient for patients who have difficulty swallowing as well as for storage, according to CMG.

Bukwang Pharmaceutical has started administering new schizophrenia drug Latuda (ingredient: lurasidone) to Korean patients in phase 3 clinical trials through a license-in agreement.

“Bukwang received the Ministry of Food and Drug Safety approval regarding the phase 3 test last year. It aims to finish clinical trials by the first half of 2019 and report findings of the clinical trial in the second half,” the company said in a statement.

Lurasidone is an atypical antipsychotic and bipolar disorder treatment developed by Sumitomo Dainippon Pharma. The drug gained FDA approval for schizophrenia in 2010 and for treating depressive episodes for bipolar I disorder in 2013. It also won the go-ahead in the EU, Switzerland, Australia, Taiwan, Russia, Singapore, Thailand and Hong Kong to treat adults with schizophrenia.

yjc@docdocdoc.co.kr

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