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[Pharmaceutical Network Enterprise News] With the advancement of the registration system, the IPO review has been accelerated, and a large number of companies have emerg.
However, the supervision of IPOs has become more and more stri.
From 2022 to May 30, a total of 213 A-share companies have attended the meeting, of which 13 have been reject.
The reasons mainly include financial accounting, standardized operation, independence, sustainable profitability, main body Qualifications and information disclosure,e.
In recent days, another company's IPO failed, and it was a pharmaceutical and biological compa.
The reason for the rejection of the IPO was that its core products were not review.
According to the data, the pharmaceutical company was established on November 13, 2015, and the joint-stock company was established on August 28, 202The company focuses on the field of drugs for cardiovascular and cerebrovascular diseases, and its main products include Aluminium-Magnesium Pirin Tablets (II), Ginkgo Biloba Capsules,e.
Among them, aluminum-magnesium pirin tablets (II) is the company's core product and is also a drug negotiated by the national medical insuran.
In the first half of 2021, the pharmaceutical company's operating income was 122 million yuan, and the net profit was 34543 million yu.
The income of aluminum magnesium pirin tablets (II) accounted for 82%, which is indeed the company's main source of inco.
Judging from the inquiries from the China Securities Regulatory Commission, the progress of the consistency evaluation of this core product has attracted much attenti.
In 2016, China issued the "Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drug.
The quality and efficacy consistency evaluation work has been deployed, requiring that the generic drugs approved for marketing before the implementation of the new registration classification of chemical drugs, if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drug, must carry out consistency evaluati.
According to the policy, drug varieties that have passed the consistency evaluation should be properly supported in medical insurance payment, and medical institutions should give priority to purchase and use them in clinical practi.
If there are more than 3 production enterprises that have passed the consistency evaluation of the same variety of drugs, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procureme.
In December 2018, the State Food and Drug Administration issued the "Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs", which stipulates that the products that have passed the evaluation will be preferentially included in the "National Essential Drugs List", and the products that have not passed the evaluation will be gradually transferred out of the li.
For the varieties included in the National Essential Medicines List, there is no longer a unified evaluation time limit requireme.
For generic drugs including essential drug varieties approved for marketing before the implementation of the new registration classification of chemical drugs, after the first variety has passed the consistency evaluation, the same varieties of other drug manufacturers should, in principle, complete the consistency evaluation within 3 yea.
It can be seen that the pharmaceutical company Aluminium-Magnesium Pirin Tablets (II) has not been reviewed y.
If other manufacturers' varieties are successively approved and reviewed, it may bring risks to the stability of the company's performan.
It is reported that the company's core product, aluminum-magnesium pirin tablets (II), has entered the national medical insurance negotiation catalogue, which is valid from March 1, 2021 to December 31, 202 Procurement catalogues in various provinces and cities with quanti.
The industry pointed out that, in fact, with the promotion of centralized procurement and medical insurance negotiations, whether the drug passes the consistency evaluation is also a common problem that many generic drug companies need to face, which is related to the subsequent development of the produ.
In addition to the unreviewed core varieties, the China Securities Regulatory Commission is also concerned about the company's aluminum-magnesium pirin tablets (II) being transferred out of the Sichuan Medical Insurance Catal.
The answer to this question will undoubtedly affect the company's continued profitabili.
Click to enter the exhibition page
However, the supervision of IPOs has become more and more stri.
From 2022 to May 30, a total of 213 A-share companies have attended the meeting, of which 13 have been reject.
The reasons mainly include financial accounting, standardized operation, independence, sustainable profitability, main body Qualifications and information disclosure,e.
In recent days, another company's IPO failed, and it was a pharmaceutical and biological compa.
The reason for the rejection of the IPO was that its core products were not review.
According to the data, the pharmaceutical company was established on November 13, 2015, and the joint-stock company was established on August 28, 202The company focuses on the field of drugs for cardiovascular and cerebrovascular diseases, and its main products include Aluminium-Magnesium Pirin Tablets (II), Ginkgo Biloba Capsules,e.
Among them, aluminum-magnesium pirin tablets (II) is the company's core product and is also a drug negotiated by the national medical insuran.
In the first half of 2021, the pharmaceutical company's operating income was 122 million yuan, and the net profit was 34543 million yu.
The income of aluminum magnesium pirin tablets (II) accounted for 82%, which is indeed the company's main source of inco.
Judging from the inquiries from the China Securities Regulatory Commission, the progress of the consistency evaluation of this core product has attracted much attenti.
In 2016, China issued the "Opinions on Carrying out the Consistency Evaluation of the Quality and Efficacy of Generic Drug.
The quality and efficacy consistency evaluation work has been deployed, requiring that the generic drugs approved for marketing before the implementation of the new registration classification of chemical drugs, if they are not approved in accordance with the principle of consistency with the quality and efficacy of the original drug, must carry out consistency evaluati.
According to the policy, drug varieties that have passed the consistency evaluation should be properly supported in medical insurance payment, and medical institutions should give priority to purchase and use them in clinical practi.
If there are more than 3 production enterprises that have passed the consistency evaluation of the same variety of drugs, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procureme.
In December 2018, the State Food and Drug Administration issued the "Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs", which stipulates that the products that have passed the evaluation will be preferentially included in the "National Essential Drugs List", and the products that have not passed the evaluation will be gradually transferred out of the li.
For the varieties included in the National Essential Medicines List, there is no longer a unified evaluation time limit requireme.
For generic drugs including essential drug varieties approved for marketing before the implementation of the new registration classification of chemical drugs, after the first variety has passed the consistency evaluation, the same varieties of other drug manufacturers should, in principle, complete the consistency evaluation within 3 yea.
It can be seen that the pharmaceutical company Aluminium-Magnesium Pirin Tablets (II) has not been reviewed y.
If other manufacturers' varieties are successively approved and reviewed, it may bring risks to the stability of the company's performan.
It is reported that the company's core product, aluminum-magnesium pirin tablets (II), has entered the national medical insurance negotiation catalogue, which is valid from March 1, 2021 to December 31, 202 Procurement catalogues in various provinces and cities with quanti.
The industry pointed out that, in fact, with the promotion of centralized procurement and medical insurance negotiations, whether the drug passes the consistency evaluation is also a common problem that many generic drug companies need to face, which is related to the subsequent development of the produ.
In addition to the unreviewed core varieties, the China Securities Regulatory Commission is also concerned about the company's aluminum-magnesium pirin tablets (II) being transferred out of the Sichuan Medical Insurance Catal.
The answer to this question will undoubtedly affect the company's continued profitabili.
Click to enter the exhibition page
