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On March 15th, the NMPA official website showed that Guangdong Dongyang Sunshine Pharmaceutical Co.
, Ltd.
's application for the listing of the 4 generic drug "Entacapone Tablets" (relevant acceptance number: CYHS1800228) entered the administrative approval stage.
It is expected that Dongyang Sunshine Pharmaceutical Co.
, Ltd.
will soon The first imitation of Entacapone is about to be officially won
.
Entacapone (trade name: Comtan) is a specific peripheral catecholamine-o-methyltransferase (COMT) inhibitor developed by Orion in Finland, which works by inhibiting COMT enzyme to reduce the metabolism of levodopa
.
In 1998, entacapone was approved in the European Union as an adjuvant drug for the standard drug levodopa/benserazide or levodopa/carbidopa for the treatment of Parkinson’s disease and end-of-dose phenomena that cannot be controlled by the above drugs ( Symptom fluctuation), approved in the United States in 2003
.
Parkinson’s disease (PD) is a common chronic degenerative disease of the nervous system in the elderly.
It is characterized by the loss of dopaminergic neurons in the substantia nigra compact area and the decrease of striatal dopamine.
The clinical features include resting tremor, muscle rigidity, and movement.
Motor symptoms such as sluggishness and postural balance disorder, as well as non-motor symptoms such as hypoosmia, constipation, abnormal sleep behavior, and depression, are the third leading killers of middle-aged and elderly people after tumors and cardiovascular and cerebrovascular diseases, which seriously affect the work ability and life of patients Quality
.
According to GlobalHealth Data's 2017 data, there are about 2.
5 million PD patients in China.
With the acceleration of the aging of the population, it is estimated that by 2030, there will be about 5 million PD patients in China
COMT inhibitors are clearly recommended by European, American and domestic treatment guidelines, and are first-line drugs that assist dopamine in the treatment of Parkinson's disease patients
.
At present, many COMT inhibitors have been approved worldwide, such as tolcapone, entacapone, and opicapone.
Among them, opicapone is the first and only one approved once-a-day COMT inhibitor.
In 2020 It was approved in the United States in April and is currently in the domestic listing application stage
.
The original research Entacapone was approved in China in May 2004 under the trade name Kedan
.
Public data shows that in 2019, Entacapone's sales in domestic public hospitals and retail terminals reached 170 million yuan, ranking third in the domestic TOP10 anti-PD drug market, with a market share of 7%
.
According to the Insight database, currently 4 domestic companies have begun to deploy the entacapone generic drug market.
Among them, Guangdong Dongyang Sunshine and Hainan General Kangli have successively submitted listing applications, Chongqing Zhien Pharmaceutical and Hainan Rizhongtian Pharmaceutical’s The generic drug of tacapone has been approved for clinical use
.
From the Insight database (http://db.
