Opicapone’s domestic launch time and approval status

Opicapone has not yet been officially approved for marketing by the National Medical Products Administration in mainland China. In other words, patients still cannot directly purchase the drug through conventional medical channels in domestic hospitals and pharmacies. As a new third-generation COMT (catechol-O-methyltransferase) inhibitor, Opicapone is mainly used in patients with Parkinson's disease in combination with Levodopa (Levodopa) to extend its "on" time and reduce "off" fluctuations. It has clear clinical significance in alleviating the fluctuations in motor symptoms in patients with moderate to advanced stages.

The drug was first developed by the Portuguese pharmaceutical companyBIAL and was approved for marketing by the European Medicines Agency (EMA) in 2016. It was also approved for marketing by the US FDA in 2020 under the trade name Ongentys. Its advantages of once-daily oral administration and good tolerability make it gradually become a new choice for adjuvant treatment of Parkinson's disease in the European and American markets. Although it has been widely used around the world, it is still in the pre-approval stage in China and has not yet entered the "projects under review" or "list for approval" in the Chinese drug registration database.

For domestic patients with Parkinson's disease, if they want to use Opicapone, they can only obtain it through overseas medical channels, such as Hong Kong SAR pharmacies, overseas drug purchases, and cross-border medical platforms. According to the current overseas market price, a box of Opicapone's European original drug costs about RMB 2,000. There are currently no generic versions of Opicapone available.

Whether Opicapone can enter the Chinese market depends on two aspects: first, whether there are domestic pharmaceutical companies or importers advancing its registration application; second, whether there is sufficient demand for the drug in the Parkinson's disease treatment market to support its investment in listing. Judging from the current domestic drug layout for the treatment of Parkinson's disease, COMT inhibitors are still mainly entacapone, which has short duration of efficacy and many adverse reactions. Therefore, the introduction of opicapone has high clinical value and market potential.

Reference materials:https://www.ongentys.com/