A batch of drugs has been evaluated first (with list)

1, a batch of drugs, over consistency evaluation recently, there are a number of pharmaceutical companies announced that there is a variety consistency evaluation.
According to the NMPA official website, Dongyangguan according to the imitation of the four categories of declared Liglitin tablets approved and treated as the same review.
it is understood that liglitin is a powerful, highly selective dipeptide peptidease-4 (DPP-4) inhibitor class oral anti-sugar drugs, combined with metformin and sulfonate drugs, combined with diet control and exercise, used to improve blood sugar control in patients with type 2 diabetes.
, originally developed by Bollinger Ingerheim, was approved by the FDA for listing in 2011 and imported by the State Drug Administration in 2013.
Minet.com data show that in 2019 China's public medical institutions terminal Ligretin tablet sales reached 246 million yuan - since the listing, the variety's annual sales growth rate of more than 100%, the first year of the market sales growth rate of up to 194.33%.
(data source: Minnet.com) has been Bollinger Ingham to occupy 100% of the market share, this time the East Sunshine won the Ligretin debut, is about to usher in a market release period. in addition to
(data source: Minnet.com), 10 products have been evaluated for consistency in recent days.
Qilu Pharmaceutical's single nitric acid isosorase slow release tablet through consistency evaluation, become the first evaluation of the product enterprise.
mononitrate sorcerer, prevention and long-term treatment of angina (heart pain caused by coronary artery vascular disease);
Nanjing Sanhe Pharmaceuticals' Vegretin tablets (specs: 50mg) were approved for listing, regarded as the same, to become the drug's fourth domestic listed enterprises.
, Vegretin is an oral DPP-4 sugar-lowering drug used to reduce blood sugar in type II diabetes patients, and is less likely to induce hypoglycemia and has no effect on the patient's weight. On the same day of
, Yangzijiang was approved for listing by the State Drug Administration according to the four generic drugs declared in the new 4 categories, as if it had passed the consistency evaluation.
, delavaban tablets for the third domestic through consistency evaluation, doso-alkali injection for the second domestic through consistency evaluation, to nadoamine capsules and radon acid tofaticloth tablets are the fourth in the country through consistency evaluation.
Jiangxi Shanxiang Pharmaceutical Co. , Ltd. 4 types of generic drug Aiomeprazole magnesium intestinal tablets were approved, as reviewed.
Stone Pharmaceutical Group 4 class of generic drug plugseib capsules were approved for listing, becoming the third domestic generic drug of the variety was approved, and as if through consistency evaluation. on July 14,
, the X-ray contrast agent iodepaol injection developed by Nanjing Zhengda Qingqing, a subsidiary of China Biopharmaceuticals, was approved by the State Drug Administration and approved as if it were consistent.
China Biopharmaceuticals is the second to be evaluated after Shanghai-based StaiLi Pharmaceuticals. On the same day
, Zhejiang CornbeI Pharmaceuticals issued a notice and received the "Pharmaceutical Supplement Application Approval" issued by the State Drug Administration on the "Pharmaceutical Supplement Application Approval" of the sodium sodium sodium tablets, which was evaluated for consistency of generic drugs.
2, reviews and collections, do you want to give up? According to incomplete statistics, a total of 972 varieties through consistency evaluation, of which 94 varieties have been collected more than three.
a number of varieties because of the number of reviews too much, but there is a "one-ground chicken hair" situation, such as sulfonate chlorate flat tablets (5mg) has been evaluated the number of manufacturers up to 28; Forest capsules (0.25g) have been passed by 16 manufacturers, hydrochloric acid metformin slow release tablets (0.5g), acetaminophen tablets (0.5g) have been passed by 15 manufacturers, after high evaluation costs, the competition of these varieties has reached a "brutal" situation.
to some extent, a lot of individual evaluation number slot, increased competition, previously by consistency evaluation to obtain advantage of the day no longer exists.
in addition, the province of belt procurement is also widely carried out, but some provinces will be procurement of varieties focused on the non-consistency evaluation, clinical use of large drugs - not into the national collection of the over-rated varieties, had to and the unrated varieties with the same stage bidding, do not distinguish the quality level, on the one hand, in this context, the over-rated varieties can maintain an advantage in the auction? On the other hand, now whether or not the evaluation should be included, consistency evaluation is no longer a ticket, pharmaceutical companies also have to consume the cost of consistency evaluation? In this regard, Huang Yong, marketing director of Yanjiang PharmaceuticalS, on The Seiber Blue analysis: for enterprises, over-consistency evaluation is not a commercial act, in order to ensure the registration of products, to solve the survival problem.
since the start of the purchase of 4 plus 7 belt, the national price reduction of the unrated varieties has become an inevitable result - according to incomplete statistics, Beijing, Shanghai, Tianjin, Shaanxi, Shanxi, Hainan, Heilongjiang and other places have launched the unselected drug gradient price reduction.
to some extent, if a variety is not evaluated, the price reduction can only temporarily keep the market, with their own variety consistency evaluation full of three, will eventually suspend the hanging network, facing a greater risk of survival, although in the short term can also be operated in the non-standard market, but with the gradual landing of the volume of procurement results, the future operational market will be less and less.
Huang Yong example: for example, chemical injections, the state has set a certain time and threshold, if the product to the end of the registration certificate has not been evaluated, the number can no longer be registered - so enterprises choose to review to solve the problem of access threshold and survival, because only over-evaluation, can live longer.
even if the enterprise's unrated varieties in the provincial collection through a large price reduction to obtain a share, but may be next year the registration certificate expires, the number is gone, so to obtain market share is not significant.
he further analysis: in the provincial collection, whether or not reviewed, enterprises will be the lowest price, because involving a province 60-70% of the market, no pharmaceutical company owners will be taken lightly.
from the enterprise's point of view, the cost of a consistent evaluation is called "sinking cost", he will not calculate the sunk cost into the operation, nor will he give up the price.
the impact of the volume of procurement on the sale of pharmaceutical products permeated every link, especially the unrated varieties.
taking the results of the implementation of the 4-7, the overall sales share of the products that were successfully counterfeited increased from 14.5% in April 2018 to 44.5% in April 2019, and the share of total sales for the same period of imitation and non-winning bid decreased from 35.6% to 17.8%.
and the impact of provincial collection is more obvious, Huang Yong believes: the national belt procurement is mainly targeted at three and above over-evaluation varieties, relatively speaking, the product will not be too much, because there is a certain technical threshold, after all, the product spent in the country's approval number, or a very small part.
but the provincial band procurement does not need the technical threshold of consistency evaluation, basically is the province's winning bid or network enterprise volume is relatively large, the use of more medical insurance funds to do the volume of procurement.
for each province, is directly for the province's varieties of sales ranking to collect - this is each province's sales cash flow products, will effectively affect the drug structure and trading varieties of agents.
for a number of unrated, large-volume varieties, even in the collection of price reduction is only temporarily to preserve the market, evaluation is the long-term strategy.
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