A batch of large varieties meets the conditions of the fifth batch of centralized procurement

With the gradual acceleration of the consistency evaluation of injections, more and more varieties will meet the requirements for centralized procurement, or may be included in the upcoming fifth batch of national centralized procurement.

1

35 injections, meeting the requirements of centralized procurement

Recently, the State Food and Drug Administration issued information on the collection of drug approval documents, flumazenil injection, amlodipine besylate dispersible tablets, piperacillin sodium and tazobactam sodium for injection, and cefminox sodium for injection.

In addition, Metronidazole Sodium Chloride Injection has been evaluated for the second time.

According to Insight database statistics, 15 injections have been collected in the first four batches of centralized procurement.

(Image source: insight database)

For a long time, the core focus of national centralized procurement has been oral preparations, which can be seen from the selection of varieties in the previous batches:

In the 4+7 volume purchase, there are 25 shortlisted varieties, and only 3 varieties of pemetrexed disodium for injection, flurbiprofen axetil injection and dexmedetomidine hydrochloride are injection varieties, and the oral dosage accounted for Than 88%.

However, it is foreseeable that the selection of varieties purchased in quantity has gradually tilted towards injection formulations: in the fourth batch of national collections, doxofylline injection, ambroxol hydrochloride injection, parecoxibna for injection, The inclusion of multiple injections such as bivalrudine for injection and pantoprazole sodium for injection is a clear signal.

2

Many provinces have tested the water

At the earliest, Shanxi Province announced the results of the first batch of drug group alliances to be selected for centralized procurement.

In October, the People's Government of Shandong Province issued the "Notice on Issuing the Implementation Plan for the Centralized Purchase of Drugs and High-value Medical Consumables in Shandong Province", including aspirin, nifedipine, metoprolol, flunarizine, and omeprazole , Rabeprazole, compound glycyrrhizin, lansoprazole, levamlodipine are commonly used varieties.

Statistics show that injections account for more than 60% of the pharmaceutical market in China's public hospitals.

In 2019, the scale of China's injection drugs reached 635.

According to data from Minai.

According to policy requirements, there are 3 or more manufacturers that meet the requirements of centralized procurement of qualified drugs (including original research drugs or reference preparations, drugs that have passed consistency evaluation, drugs approved under the new classification, and drugs in the "China List of Listed Drugs").

With the gradual acceleration of the consistency evaluation of injections, more and more varieties will meet the requirements for centralized procurement, or may be included in the upcoming fifth batch of national centralized procurement.

3

What issues should be paid attention to when injections are used in centralized procurement?

The market involved in injections exceeds 100 billion yuan.

It is understood that as a high-risk dosage form, injections are directly injected into blood vessels, tissues or organs, which are absorbed quickly and act quickly.

The Drug Evaluation Center of the State Food and Drug Administration and the National Adverse Drug Reaction Monitoring Center released the "2019 National Adverse Drug Reaction Monitoring Report" showing that 477,000 new and serious adverse reaction/event reports were received in 2019, accounting for the total number of reports 31.

The incidence of adverse reactions of injections is still relatively high.
In the reports of adverse reactions/events of chemical drugs, 66.
2% were related to injections; in biological preparations, this number was as high as 97.
5%.
In the field of traditional Chinese medicine, the adverse reactions/event reports of injection administration accounted for 45.
5%, of which intravenous infusion accounted for more than 98%.

It is also necessary to pay attention to a figure.
Anti-tumor injections account for the largest proportion of serious adverse reactions/events related to anti-infective drugs, cardiovascular drugs, anti-tumor drugs, and elderly medications, as high as 89.
5%.

In the distribution of over-evaluated injection therapy in 2020, anti-tumor and immunomodulators accounted for 15.
48%, second only to nervous system drugs and systemic anti-infective drugs.

This means that injections, especially drugs with a narrow therapeutic window, are included in the collection, and more attention should be paid to safety and effectiveness.
In this context, when medical insurance funds are tight and medical insurance control fees become more stringent, over-rated injections that meet the requirements for centralized procurement may be preferred, and relevant companies are also facing opportunities to increase their visibility and market sales.