"Sales Crown" broke 8 billion for the first time, and Renfu Medicine attacked sustained and controlled release preparations!

　　Recently, Okoda/Conba's lamotrigine sustained-release tablets were the first to be produced, and no first copy of this product has been approved yet
.
According to data from Minet.
com, among the TOP10 oral sustained-release preparations in China's three major terminals and six major markets in 2021, the first on the list will exceed 8 billion yuan, 8 of which have been included in the national centralized procurement, and the third-ranked felodipine sustained-release tablet Or included in the eighth batch of centralized procurement, the market pattern will change
.
In terms of new classification declarations, the number of varieties declared by Renfu Medicine is far ahead, and 6 of them are sprinting for the first imitation
.
"Sales Crown" broke 8 billion for the first time! The TOP10 pattern of oral sustained and controlled release preparations will change.
Compared with ordinary preparations, oral sustained and controlled release preparations have obvious clinical advantages, such as reducing the frequency of medication and improving patient medication compliance; having higher bioavailability, improving drug efficacy; reducing drug toxicity side effects, improve drug safety,
etc.
Oral sustained-release preparations are widely used in chronic diseases that require long-term medication, including cardiovascular and cerebrovascular systems (hypertension, hyperlipidemia, etc.
), digestive system and metabolism (mainly diabetes) and other therapeutic fields
.
According to data from Minet.
com, in 2021, the total sales volume of TOP10 oral sustained and controlled release preparations in China's three major terminals and six major markets (see the end of this article for details) will exceed 23 billion yuan, a year-on-year increase of 7.
82%.
Among them, there are 5 central cerebrovascular system drugs.
, digestive system and metabolism drugs and nervous system drugs have 2 each
.
Seven of the 10 products have annual sales of more than 1 billion yuan.
Nifedipine controlled-release tablets, which ranked first on the list, exceeded 8 billion yuan for the first time, a year-on-year increase of 20.
37%; Metoprolol succinate sustained-release tablets followed closely with sales.
The sales amount exceeded 3.
7 billion yuan, with a growth rate of 11.
17%; the sales of felodipine sustained-release tablets ranked third exceeded 2.
7 billion yuan, a year-on-year increase of nearly 9%
.
In 2021, China's three major terminals and six major market oral sustained-release preparations TOP10 product sources: Minet database in 2021 China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminals, The TOP10 products and ranking of oral sustained and controlled release preparations are consistent with the six major markets of the three major terminals.
It can be seen that the in-hospital market is the "main battlefield" for oral sustained and controlled release preparations, which means that this type of drugs is also easily affected by centralized procurement.

.
Eight of the TOP10 products have been included in the national centralized procurement
.
Tamsulosin Hydrochloride Sustained-Release Capsules is the third batch of centralized collection varieties.
In 2021, the sales volume in China's three major terminals and six major markets will decline by 36.
23%, of which the sales in China's public medical institutions will decline by more than 45%.
The sales of metformin hydrochloride sustained-release tablets included in the third batch of centralized procurement have increased slightly, which may be related to the low market concentration and the high volume of products of "barefoot" enterprises
.
The sales of products with relatively mature stocks in the market will decline under the price reduction of centralized procurement, while the incremental products that have not yet opened the market are still expected to achieve slight growth under centralized procurement
.
But in general, with the implementation of the national centralized procurement, and more and more products have been reviewed and included in the centralized procurement, the market structure of oral sustained and controlled release preparations will also usher in a reshuffle
.
Renfu and Hengrui have led the evaluation list, and 3 oral sustained-release preparations are preparing for the eighth batch of centralized procurement.
At present, more than 40 oral sustained-release preparations (calculated by drug name) have passed or are deemed to have passed the consistency evaluation, among which hydrochloric acid More than 30 companies have passed the evaluation of metformin sustained-release tablets, and more than 10 companies have passed the evaluation of ibuprofen sustained-release capsules, pramipexole hydrochloride sustained-release tablets, and nifedipine controlled-release tablets
.
Judging from the review companies, Renfu Pharmaceutical leads the way with 8 oral sustained and controlled release preparations (calculated by drug name).
In addition, Hengrui Medicine, China Resources Pharmaceutical, and Nanjing Yiheng Pharmaceutical have reviewed 5 oral sustained and controlled release preparations.
and above
.
21 oral sustained and controlled release preparations (15 generic drugs) have been included in the national centralized procurement, of which there is one in the second batch, 3 in the third and fourth batches, and the fifth and seventh batches.
There are 4 batches collected
.
Among the 20 oral sustained and controlled release preparations (18 generic drugs) that have not been included in the national centralized procurement, 3 generic drugs have formed a "1+3" and above competition pattern, meeting the centralized procurement conditions, including amphetamines.
Sustained-release and controlled-release dosage form of ketone, mirabegron sustained-release and controlled-release dosage form, and felodipine sustained-release and controlled-release dosage form
.
Oral sustained-release preparations that have been reviewed by companies and have not yet been included in the national procurement Note: Not sold or with sales less than 100 million yuan, use * to represent source: Minenet database Felodipine is a calcium channel blocker and is a first-line long-term effective antihypertensive drugs
.
At present, the dosage forms of felodipine that have been marketed in China mainly include tablets, sustained-release tablets, sustained-release capsules, etc.
Among them, oral sustained-release preparations dominate, and there are only a few approved companies, and the market competition pattern is good
.
According to the data of Minet.
com, among the TOP20 products of oral sustained-release preparations in public medical institutions in China in 2021, felodipine sustained-release tablets and felodipine sustained-release tablets (II) are all on the list, among which felodipine sustained-release tablets ranked third
.
At present, the market of felodipine sustained-release dosage forms is still dominated by the original manufacturer AstraZeneca.
There are 4 Hefei Lifang Pharmaceuticals, Nanjing Yiheng Pharmaceuticals, Beijing Sihuan Kebao Pharmaceuticals, Tianjin Tasly Sainte Pharmaceuticals/Shanghai Ambison Pharmaceuticals The product of the company has been reviewed, and the drug is likely to be included in the eighth batch of centralized procurement
.
23 first imitations are on the horizon, focusing on the nervous system 100 billion market.
Since August, a number of oral sustained and controlled release preparations have been submitted for marketing under new registration categories, including Shisiyao's nifedipine sustained-release tablets, Aokeda/ Conba's lamotrigine sustained-release tablets, Beijing Fuyuan Medicine 's fluvastatin sodium sustained-release tablets,
etc.
According to the data of Minet.
com, there are currently more than 60 oral sustained and controlled release preparations (calculated by drug name), and some companies have submitted clinical/marketing applications under the new registration classification.
Released preparations are declared under the new classification, of which 7 have been approved for production and are deemed to have been reviewed
.
Source of oral sustained and controlled release preparations declared by the new classification of Renfu Medicine: Among the oral sustained and controlled release preparations under review in the new version of Minet.
com, according to incomplete statistics, 23 have not been approved for the first time (including the first imitation of the dosage form), of which 17 declared by the sole enterprise
.
In terms of therapeutic areas, 14 of the 23 oral sustained and controlled release preparations are neurological drugs
.
According to data from Minet.
com, in 2021, the scale of the terminal nervous system chemical drug market in China's public medical institutions will exceed 100 billion yuan, a year-on-year increase of 6.
31%
.
Some of the oral sustained and controlled-release preparations that have been declared for a new classification by enterprises but have not yet been approved for the first copy.
Orphanone sustained-release tablets and hydromorphone hydrochloride/phenidone sustained-release tablets are exclusively declared by the company; Yangzijiang Pharmaceuticals and Hefei Lifang Pharmaceutical have 2 oral sustained-release preparations to be copied, among which methylphenidate hydrochloride sustained-release tablets are produced by Hefei Lifang Pharmaceutical's exclusive declaration
.
Source: Minet database, CDE official website, etc.
Note: Minet's "China's Three Major Terminals and Six Market Competition Patterns", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies And online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; the above sales are calculated based on the average retail price of the product in the terminal
.
The statistics are as of August 17.
If there are any omissions, please correct me! "Sales Crown" broke 8 billion for the first time! The TOP10 pattern of oral sustained-release preparations will become a blessing , and Hengrui will lead the ranking list.
3 oral sustained-release preparations are preparing for the eighth batch of centralized procurement drugs　.