Qilu's first over 100 million antihypertensive drug appraised the first domestically produced $1 billion variety

Recently, Qilu Pharmaceutical has made new progress in the field of hypertension medication: carvedilol tablets have been successfully reviewed, the first in China, and the sales of this product in China's public medical institutions will exceed 100 million yuan in 2020; Riociguat tablets reported It is the first domestically produced drug, and currently no generic drugs have been approved in China
.
Source: State Food and Drug Administration's official website On March 31, the State Food and Drug Administration's official website showed that Qilu Pharmaceutical's carvedilol tablets were successfully evaluated, the first in China
.
Carvedilol is an α and β receptor blocker, which can dilate blood vessels while blocking the receptors.
It is clinically used for patients with mild to moderate hypertension or with renal insufficiency and diabetes.
It can also be used to treat symptomatic patients.
of congestive heart failure
.
There are more than ten domestic companies that have the approval for the production of carvedilol tablets.
According to Minet.
com, the product will be used in urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) terminals in China in 2020.
Sales of more than 100 million yuan, of which Qilu Pharmaceutical exclusively occupies 70% of the market
.
At present, only Qilu Pharmaceutical has submitted a supplementary application for the consistency evaluation of carvedilol tablets, and now it has successfully passed the evaluation, which is conducive to consolidating the original market
.
The source of the hypertension drug Qilu Pharmaceutical recently reported: CDE official website On March 25, the CDE official website showed that Qilu Pharmaceutical was accepted by the CDE for its marketing application for generic 4 types of riociguat tablets
.
Riociguat is a soluble guanylate cyclase (sGC) agonist, mainly used for the treatment of chronic thromboembolic pulmonary hypertension and arterial pulmonary hypertension, with global sales exceeding $1 billion in 2021
.
Bayer's riociguat tablets were approved for import in September 2017 and have been negotiated into the national medical insurance category B catalog.
According to data from Minet, the sales growth rate of this product in China's public medical institutions exceeded 200% in the first half of 2021.

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At present, only Qilu Pharmaceutical has submitted the listing application for Riociguat tablets under the new registration classification, and no company has started the BE trial of this product, so Qilu Pharmaceutical has a high probability of winning the first copy.

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Sources of drugs for hypertension that have been reviewed by Qilu Pharmaceuticals: Minenet MED2.
0 China Drug Evaluation Database Home review, esmolol hydrochloride injection is the second review
.
Source: Minet database, the official website of the State Food and Drug Administration, etc.
Note: The statistics are as of April 1.
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