The website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced that Fosun Pharma and Bial Portela&Ca have jointly applied for the marketing of the Class 5.1 new drug, Opicapon Capsules, which has been accepted.

 

 

 

Public information shows that this is Opicapone capsule, a new drug introduced by Fosun Pharma for the treatment of primary Parkinson's disease, which is a next-generation catechol oxygen methyltransferase inhibitor (COMT).

 

 

 

Public information shows that opicapone is a new generation of peripheral catechol O-methyltransferase (COMT) inhibitor, developed by Bial Portela, Portugal. It was first approved by the European Union in June 2016 as an adjuvant therapy for levodopa/dopa decarboxylase inhibitors (DDCI, such as carbidopa) to treat Parkinson's disease patients with unstable control of motor symptoms due to terminal effects. The product name is Ongentys.

 

 

 

Subsequently, Opicarbone was approved for marketing in the United States and Japan in April 2020 and June 2020, respectively. In the United States, it was approved for use as an adjunct to levodopa/carbidopa therapy in Parkinson's disease patients with "on-off" phenomenon. The "on/off" phenomenon refers to the fluctuation of symptoms between sudden relief (on phase) and exacerbation (off phase), which is unpredictable and independent of the time of medication and blood drug concentration. The end of dose phenomenon refers to the phenomenon where the duration of the medication effect decreases after each dose, and the symptoms of Parkinson's disease worsen in the later stages of each dose, until the symptoms gradually improve after taking the medication again.

 

 

 

Wanbang Pharmaceutical, a subsidiary of Fosun Pharmaceutical, reached an agreement with Bial on January 9, 2018 to introduce Ongentys' development rights and interests in Chinese Mainland, excluding Hong Kong, Macao and Taiwan, China transactions, including a down payment of $2.5 million and a mileage fund of $12.5 million.

 

 

 

Opicapon is a long-acting, third-generation COMT inhibitor that only needs to be taken once a day. Its mechanism of action is to protect levodopa by reducing its breakdown in the blood, thereby allowing more levodopa to reach the brain, prolonging its clinical efficacy, and helping patients achieve control of motor symptoms.

 

 

 

Multiple studies have confirmed that opicarpone can increase the levels of levodopa reaching the brain and help reduce the dosage of levodopa and its associated side effects. Combined use with levodopa and DDC inhibitor carbidopa can further reduce the occurrence of Parkinson's disease in patients.

 

 

 

On March 10, 2021, Fosun Pharma's application for the import and market registration of the new Parkinson's disease drug, Opicapon Capsules, was officially accepted by CDE, and now the import application has also been accepted. With the introduction of this Opicapon capsule by Fosun Pharma and its application for market launch in China, it means that it is expected to benefit more Parkinson's disease patients in the near future, helping them recover lost functions, prevent and control disease progression.

 

 

 

It is understood that Fosun Pharma is actively expanding its presence in the field of aging related treatments. On August 22nd of this year, the company announced on an interactive platform that its investigational product, Opicapone capsules, is intended for the treatment of Parkinson's syndrome. In the medical device business, the holding subsidiary Meizhong Mutual Benefit and Insightec have established a joint venture company, Fosun Medical Vision, in China, dedicated to the commercial expansion, clinical application, and research of magnetic resonance guided focused ultrasound brain therapy systems in the Chinese and Hong Kong and Macau markets, aiming to help Parkinson's disease patients and essential tremor patients regain a high-quality life.