BRIEF—Chinese approval for schizophrenia drug Latuda

Japan’s Sumitomo Dainippon Pharma today announced today that the Chinese National Medical Products Administration (NMPA) has granted an import drug license for Latuda (lurasidone hydrochloride), an atypical antipsychotic, for the treatment of patients with schizophrenia.

The import drug license application was submitted in December 2015.

Sumitomo Pharmaceuticals (Suzhou), a wholly-owned subsidiary of Sumitomo Dainippon Pharma in China, plans to launch Latuda in China in fiscal year 2019 after the necessary procedures are implemented.

Through the approval in China for Latuda, Sumitomo Dainippon Pharma expects to make a contribution to the treatment of patients with schizophrenia in China by offering Latuda as a new treatment option.

Latuda was approved for the treatment of schizophrenia in the USA in 2010, and for bipolar depression in 2013, and it has also received approvals in Europe, Canada, Russia and other markets. It still awaits approval in Japan.