Domestic drugs accelerate their entry into the Parkinson’s disease market and the proportion of imported drugs in the Parkinson’s disease market drops by 4% in half a year

According to reports, the drug Sinemet (Sinemet) for Parkinson's disease (Parkinson's disease) is out of stock recently.
The main reason is the shortage of raw materials and repeated epidemics
.
After the promulgation of the fourth edition of the "Guidelines for the Treatment of Parkinson's Disease in China" in 2020, the recommended medications for the third edition of the guidelines in 2014 have been updated
.
In addition, major policies such as national talks and centralized procurement have promoted differentiated treatment for patients with Parkinson's disease in China
.
According to data released by the Neurology Branch of the Chinese Medical Association, there are more than 3 million Parkinson's disease patients in China, and the incidence rate of people over 65 in China is 1.
70%, and the number of new patients will reach about 100,000 every year
.
The fourth edition of the "Guidelines for the Treatment of Parkinson's Disease in China" in 2020 emphasizes MAO BI (rasagiline and selegiline) and DAs (ropinirole) modification therapy for early Parkinson's disease.

.
Two-channel blockers Safinamide and Zonisamide have been added to MAO-BI, and Opicapone and Amantadine sustained-release tablets have been added to COMTI
.
At the same time, the high-dose dosing regimen of pramipexole and coenzyme Q10 was removed; the prescriptions for ergot DAs and the combination therapy of selegiline and vitamin E were removed
.
In recent years, new drugs against Parkinson's disease have been continuously launched globally
.
According to a report by the US GBI Research Business Intelligence Agency, with the incentive of new drugs being launched, the global sales of Parkinson's disease drugs in 2021 will exceed 3.
2 billion U.
S.
dollars
.
The domestic market exceeds 3 billion yuan.
According to data from Meinenet, there are 15 chemically-named varieties of anti-Parkinson's disease drugs approved for marketing in China
.
In 2020, the amount of anti-Parkinson's disease drugs used in public hospitals in key provinces and cities in China reached 620 million yuan, an increase of 8.
51% over the previous year
.
The top 10 varieties are pramipexole tablets, dopasrazide tablets/capsules, entacapone tablets, piribedil tablets, selegiline tablets, rasagiline tablets, trihexyphenid ​​tablets, Encatapone didopa tablets, ropinirole tablets and karzo didopa tablets
.
It is predicted that the amount of Parkinson's disease treatment drugs used in public medical institutions and retail markets in China will exceed 3 billion yuan
.
At present, among the anti-Parkinson's disease drugs, four varieties of pramipexole, trihexyphenidyl, entacapone and rasagiline have passed the consistency evaluation by manufacturers
.
Among them, pramipexole tablets have the most reviewed manufacturers, with 10 companies already
.
In March 2021, Entacapone of Guangdong Dongyang Sunshine Pharmaceutical Co.
, Ltd.
was listed as the first company to be listed in the priority review by CDE with its new 4 generic drugs, and it was exclusively reviewed
.
In June 2021, Qilu Pharmaceutical and Changzhou Siyao Pharmaceutical's new 4 types of generic drugs for rasagiline mesylate were launched on the market as over-evaluated
.
Benhexol tablets were reviewed by Tianjin Lisheng and Jiangsu Tasly Diyi Pharmaceutical
.
With the pricing competition of the fourth batch of nationally sourced pramipexole tablets, the price of the drug has dropped sharply, resulting in a growth rate of only 3.
54% in the anti-Parkinson's disease drug market in the first half of 2021
.
The main varieties with a decline in growth rate are Boehringer Ingelheim’s Pramipexole tablets (Semfro), Merck’s Carzodopa sustained-release tablets (Sining) and Servier’s Piribedil sustained-release tablets (Thailand).
Serta)
.
Imported brands accounted for a 4% decline.
Data shows that China’s Parkinson’s disease treatment drug market is dominated by imported drugs
.
In the first half of 2021, domestic public hospitals' original research drugs accounted for 90.
97%.
Boehringer Ingelheim of Germany, Roche of Switzerland, Orion of Finland, Servier of France, Teva of Israel, Merck & Co.
of the United States, GlaxoSmithKline of the United Kingdom, and Belgian Shibi waits for 8 companies to control
.
Domestic drugs account for less than 10%
.
With the promotion of policies such as the quality and efficacy consistency evaluation of domestic generic drugs and national talks about price reduction, the drug market has been shuffled frequently
.
The TOP3 suppliers of domestic anti-Parkinson's disease drugs in public hospitals in 2020 are Chongqing Zhien Pharmaceutical, Changzhou CommScope Pharmaceutical, and Jiangsu Tasly Diyi Pharmaceutical
.
Under the influence of the fourth batch of nationally organized drug procurement in February 2021, the pattern of anti-Parkinson's drugs changed in the first half of 2021.
Zhejiang Jingxin Pharmaceutical and CSPC Ouyi Pharmaceutical entered the top three domestic manufacturers
.
The proportion of imported brand-name drugs in the public hospital market has dropped by 4% compared with 2020
.
Variety changes Pramipexole forms a "1+10" pattern.
Pramipexole is a non-ergotamine dopamine receptor agonist developed and listed by Boehringer Ingelheim, Germany
.
In July 1997, it was approved by the US FDA for listing under the trade name Sifrol
.
In 2009, Pramipexole's global sales reached a peak of 1.
117 billion euros
.
On December 30, 2005, Pramipexole was approved to be registered and listed in China under the trade name Senfaluo
.
On August 1, 2014, pramipexole sustained-release tablets was approved for registration and marketing
.
At present, pramipexole is the most approved PD drug variety in China
.
In 2018, Zhejiang Jingxin Pharmaceutical's products were approved for listing for the first time.
Subsequently, the products of Jiangsu Hengrui Pharmaceutical, Haisco Pharmaceutical (Meishan) and Qilu Pharmaceutical (Hainan) were approved to be listed and passed the consistency evaluation
.
In 2021, 5 companies including Lipin Pharmaceutical (Xiamen), Beijing Peking University Weixin Biotechnology, Tianjin Hongri Pharmaceutical, Chengdu Kanghong Pharmaceutical Group and Shenzhen Hanyu Pharmaceutical have been approved and evaluated as generic drugs in 4 categories, forming The original research domestically produced "1+10" pattern
.
According to data from Minai.
com, the amount of pramipexole used in public hospitals in key provinces and cities in China in 2020 is nearly 300 million yuan, an increase of 10.
63% over the previous year
.
In 2021, after the fourth batch of national sourcing contests, prices have dropped sharply, rewriting the situation that imported pramipexole dominated the domestic market before 2018
.
In the first half of 2021, a "1+5" pattern of imports and domestic production has been formed
.
After the centralized procurement of national medicines, the trend of domestic imitations instead of imports is irreversible
.
According to public data, the prices of the original research drug "Senfolo" sustained-release tablets 0.
375g, 0.
75g and regular-release tablets 0.
25mg have decreased by 63.
10%, 80% and 15.
10%, respectively
.
The average price of the three specifications of "Soprol" of Zhejiang Jingxin Pharmaceutical has dropped by 80.
53%, and the price of other pharmaceutical products has also dropped by about 80%
.
Zhejiang Jingxin Pharmaceutical's products are expected to sell more than 25 million tablets in 2021, which is 8-10 times that of last year
.
The "gold standard" levodopa compound is growing steadily.
The levodopa compound is the "gold standard" medication for Parkinson's disease
.
In the foreign drug market for Parkinson's disease, levorotatory carbidopa accounts for 17.
27%, dopasrazine accounts for 16.
20%, and droxidopa accounts for 11.
92%
.
In the first half of 2021, public hospitals in major cities in China dopasensezide accounted for 23.
55%, encatapone didopa accounted for 2.
32%, carzodopa accounted for 1.
25%, and droxidopa accounted for 0.
22%
.
Dopaserizide is a compound preparation of levodopa and benserazide.
In the mid-1970s, Roche’s products were approved for marketing; in 2003, Shanghai Roche’s dopaserizide tablets were included in the Chinese Drug Catalogue, with the trade name US Doba
.
The domestically marketed dopasizide capsules are produced by Shanghai Yishengyuan Pharmaceutical, Shanghai Fuda Pharmaceutical, Guangzhou Baiyunshan Pharmaceutical General Factory, and Guangzhou Baiyunshan Hanfang Modern Pharmaceutical
.
According to data from Minai.
com, in 2020, the amount of dopaserizide used in public hospitals in key provinces and cities in China will be 130 million yuan, and the growth rate in the first half of 2021 will be 8.
78%
.
Roche's Medoba occupies more than 98% of the market, and domestic dopasrazide capsules account for about 2%
.
The generic drug of dopasrazide tablets has entered the development schedule
.
The ups and downs of carbodipa carbodipa is a drug approved by DuPont Pharmaceuticals in May 1991.
It is composed of carbidopa-levodopa and its trade name is Sinemet.

.
The marketing license holder in China is MSD Sharp & Dohme GmbH, manufactured by Savio Industrial SrL
.
Carbidopa-levodopa developed by Jinghua Pharmaceutical Group was approved for production in 1995, and its trade name is "Silaimei"
.
According to data from Minai.
com, the amount of carbodipa used in public hospitals in key provinces and cities in China in 2020 is 14.
6 million yuan, an increase of 38.
62% over the previous year
.
At present, in the domestic carbidopa and levodopa market, the imported drug Sinin accounts for more than 90%
.
There is a certain correlation with the dosage form and specification.
Si Laimei is a 250mg levodopa + carbidopa 25mg tablet, and Xining is a levodopa 200mg + carbidopa 50mg sustained-release tablet
.
It can be seen that the production of domestic sustained-release tablets is an urgent task
.