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According to relevant national policies, the types, quality and efficacy of drugs that have passed the consistency evaluation are equivalent to the original research products, and appropriate support will be given in terms of medical insurance payment and procurement by medical institutions
.
Therefore, in recent years, it can be found that more and more companies are accelerating the promotion of product reviews to enrich the company's product structure, show the company's excellent R&D level and quality control capabilities, and provide patients with richer and more complete treatment plans
.
For example, recently, according to the NMPA website, Hanyu Pharmaceutical's somatostatin for injection has passed the consistency evaluation of generic drugs, which is the first domestic appraisal
.
Data show that in 2020, the sales of terminal somatostatin in public medical institutions in China will exceed 2.
4 billion yuan
.
It is understood that as one of the domestic companies with a large variety of peptide drugs, Hanyu Pharmaceuticals has 24 peptide drugs, 9 new drug certificates, and 17 clinical approvals as of the end of August
.
It is worth mentioning that with its abundant product reserves, Hanyu Pharmaceutical has ushered in a harvest period this year in terms of consistency evaluation
.
According to the semi-annual report, Hanyu Pharmaceutical has submitted a supplementary application for consistency evaluation of 7 products to the State Food and Drug Administration.
As of August 27, 2021, the company has added carbetocin injection and thymus method for injection.
The three products of eptifibatide injection passed the consistency evaluation.
Among them, the thymus method for injection won the fifth batch of national centralized procurement.
After the implementation of the procurement, it will contribute to the company's profits
.
At present, while actively deploying consistency evaluation, Hanyu Pharmaceuticals is also increasing the integration of internal and external resources by reaching strategic cooperation and strengthening the marketing team, and continues to make efforts to target the incremental opportunities of peptide drugs in the non-centralized procurement market
.
Coincidentally, on the same day, Huiyu Pharmaceutical's Palonosetron Hydrochloride Injection, which was produced in the generic category 4, was also approved for marketing, which was deemed to have passed the consistency evaluation
.
According to data, Palonosetron hydrochloride is the second-generation 5-HT3 receptor antagonist.
In 2020, the terminal Palonosetron injection sales of public medical institutions in China will exceed 1.
5 billion yuan
.
From the above point of view, the industry believes that under the background of continuous changes in the pharmaceutical market and the normalization of centralized procurement, the enthusiasm of pharmaceutical companies to participate in consistency evaluation is constantly increasing
.
With the continuous advancement of the consistency evaluation and the reform of the drug review and approval system, after a large number of provinces and cities have suspended the listing of unreviewed drugs, it is expected that more and more companies will begin to speed up the layout consistency evaluation work
.
According to the author’s understanding, recently the Liaoning Provincial Drug and Medical Consumables Centralized Procurement Network issued an announcement stating that more than 3 companies (based on the imitations approved by the new registration classification) of the same type of drugs (in terms of specifications) purchased online in Liaoning Province have been reviewed.
Pharmaceuticals are considered as over-rated and included in the statistical scope, and reference preparations and original research drugs are not included in the statistical scope).
For other drugs that have been purchased online in Liaoning Province but have not yet been evaluated, online procurement will be suspended, and for those who have not been online in Liaoning Province.
The evaluated drugs are temporarily not included in the scope of centralized procurement in Liaoning Province
.
According to the announcement, as of October 20, 2021, Liaoning Province has planned to suspend online purchases of 169 drugs that have been online but have not been reviewed, involving 111 companies including Chenxin Pharmaceutical, North China Pharmaceutical, Shijiazhuang Siyao, and Qilu Pharmaceutical
.
In general, carrying out the consistency evaluation of generic drugs can make the generic drugs consistent with the original drugs in terms of quality and efficacy, and can replace the original drugs in the clinic.
This can save medical costs and improve the quality of China's generic drugs.
And the overall development level of the pharmaceutical industry to ensure the safe and effective use of medicines by the public
.
Therefore, in the context of superimposing products that cannot pass the consistency evaluation in the future or it will be difficult to obtain market access, the industry expects that the number and speed of companies passing the consistency evaluation will increase and accelerate in the future
.
.
Therefore, in recent years, it can be found that more and more companies are accelerating the promotion of product reviews to enrich the company's product structure, show the company's excellent R&D level and quality control capabilities, and provide patients with richer and more complete treatment plans
.
For example, recently, according to the NMPA website, Hanyu Pharmaceutical's somatostatin for injection has passed the consistency evaluation of generic drugs, which is the first domestic appraisal
.
Data show that in 2020, the sales of terminal somatostatin in public medical institutions in China will exceed 2.
4 billion yuan
.
It is understood that as one of the domestic companies with a large variety of peptide drugs, Hanyu Pharmaceuticals has 24 peptide drugs, 9 new drug certificates, and 17 clinical approvals as of the end of August
.
It is worth mentioning that with its abundant product reserves, Hanyu Pharmaceutical has ushered in a harvest period this year in terms of consistency evaluation
.
According to the semi-annual report, Hanyu Pharmaceutical has submitted a supplementary application for consistency evaluation of 7 products to the State Food and Drug Administration.
As of August 27, 2021, the company has added carbetocin injection and thymus method for injection.
The three products of eptifibatide injection passed the consistency evaluation.
Among them, the thymus method for injection won the fifth batch of national centralized procurement.
After the implementation of the procurement, it will contribute to the company's profits
.
At present, while actively deploying consistency evaluation, Hanyu Pharmaceuticals is also increasing the integration of internal and external resources by reaching strategic cooperation and strengthening the marketing team, and continues to make efforts to target the incremental opportunities of peptide drugs in the non-centralized procurement market
.
Coincidentally, on the same day, Huiyu Pharmaceutical's Palonosetron Hydrochloride Injection, which was produced in the generic category 4, was also approved for marketing, which was deemed to have passed the consistency evaluation
.
According to data, Palonosetron hydrochloride is the second-generation 5-HT3 receptor antagonist.
In 2020, the terminal Palonosetron injection sales of public medical institutions in China will exceed 1.
5 billion yuan
.
From the above point of view, the industry believes that under the background of continuous changes in the pharmaceutical market and the normalization of centralized procurement, the enthusiasm of pharmaceutical companies to participate in consistency evaluation is constantly increasing
.
With the continuous advancement of the consistency evaluation and the reform of the drug review and approval system, after a large number of provinces and cities have suspended the listing of unreviewed drugs, it is expected that more and more companies will begin to speed up the layout consistency evaluation work
.
According to the author’s understanding, recently the Liaoning Provincial Drug and Medical Consumables Centralized Procurement Network issued an announcement stating that more than 3 companies (based on the imitations approved by the new registration classification) of the same type of drugs (in terms of specifications) purchased online in Liaoning Province have been reviewed.
Pharmaceuticals are considered as over-rated and included in the statistical scope, and reference preparations and original research drugs are not included in the statistical scope).
For other drugs that have been purchased online in Liaoning Province but have not yet been evaluated, online procurement will be suspended, and for those who have not been online in Liaoning Province.
The evaluated drugs are temporarily not included in the scope of centralized procurement in Liaoning Province
.
According to the announcement, as of October 20, 2021, Liaoning Province has planned to suspend online purchases of 169 drugs that have been online but have not been reviewed, involving 111 companies including Chenxin Pharmaceutical, North China Pharmaceutical, Shijiazhuang Siyao, and Qilu Pharmaceutical
.
In general, carrying out the consistency evaluation of generic drugs can make the generic drugs consistent with the original drugs in terms of quality and efficacy, and can replace the original drugs in the clinic.
This can save medical costs and improve the quality of China's generic drugs.
And the overall development level of the pharmaceutical industry to ensure the safe and effective use of medicines by the public
.
Therefore, in the context of superimposing products that cannot pass the consistency evaluation in the future or it will be difficult to obtain market access, the industry expects that the number and speed of companies passing the consistency evaluation will increase and accelerate in the future
.