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

Pharmaceutical network July 20, 1, a batch of drugs, over consistency evaluation recently, there are a number of pharmaceutical companies announced that there is a variety consistency evaluationAccording to the NMPA official website, Dongyangguan according to the imitation of the four categories of declared Liglitin tablets were approved and treated as reviewedIt 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 diabetesThe Liglitin was originally developed by Bollinger Ingerheim and was approved by the FDA for listing in 2011 and imported by the State Drug Administration in 2013According to Minnet.com, sales of Ligretin tablets at the end of China's public medical institutions reached 246 million yuan in 2019 - the annual sales growth rate of the variety has exceeded 100% since its listing, and the sales growth rate in the first year of listing is as high as 194.33%(Data source: Minnet.com) has been Bollinger Ingham occupies 100% of the market share, this time the East Sunshine won the Ligretin debut, is about to usher in a market release periodIn addition to (data source: Minnet.com), in recent days, 10 products have passed consistency evaluationsQilu Pharmaceutical's single nitric acid isosyser slow release tablet through consistency evaluation, become the first evaluation of the product enterpriseSingle nitric acid sororbate slow release tablets to prevent and long-term treatment of angina (heart pain caused by coronary artery vascular disorder); Nanjing Sanhe Pharmaceuticals' Viglitin tablet (spec: 50mg) was approved for listing, which was rated as the fourth domestically listed company for the drugVigretin is an oral DPP-4 sugar-lowering drug used to lower blood sugar in type II diabetes patients, and is less likely to induce hypoglycemia and has no effect on the patient's weightOn the same day, Yangzijiang was approved for listing by the State Drug Administration according to the four generic drugs declared in the new 4 categories, regardless of the adoption of a consistency evaluationAmong them, delavata ban tablets for the third domestic through consistency evaluation, doso-alkali injection for the second domestic through consistency evaluation, to nadoamine capsules and radon acid tofati cloth tablets are the fourth in the country through consistency evaluationJiangxi Shanxiang Pharmaceutical Co, Ltd4 types of generic drug Aiomeprazole magnesium intestinal tablets were approved, as reviewedStone Pharmaceutical Group 4 class of generic drug plugse-turned-cloth capsules were approved for listing, becoming the third domestic generic drug of this variety was approved, and as if it passed the consistency evaluationOn July 14, the X-ray contrast agent iodisol injection developed by Nanjing Zhengda Qingqing, a subsidiary of China Biopharmaceuticals, was approved by the State Drug Administration and treated as if it had been evaluated for consistency China Biopharmaceuticals is the second-largest company to be evaluated after Shanghai-based StaiLi Pharmaceuticals On the same day, Zhejiang CornbeI Pharmaceuticals issued a notice and received the "Drug Supplement Application Approval" issued by the State Drug Administration on the sodium sodium sodium tablets of protoprazole, which was evaluated for consistency through generic drugs 2, over-reviewed and collected, 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 There have been a number of varieties because of the number of reviews too much, but there has been a "one-ground chicken hair" situation, such as sulfonate chlorate flat tablets (5mg) has been evaluated the number of manufacturers up to 28; Moxirin capsules (0.25g) have been passed by 16 manufacturers; hydrochloride metformin slow release tablets (0.5g), acetaminophen tablets (0.5g) have been adopted by 15 manufacturers, after high evaluation costs, the competition of these varieties has reached a " tragic" situation To some extent, many individual s/hes slots are more than the number of reviews, competition intensifies, and the days before the days of gaining an advantage by consistency evaluation no longer exist In addition, the province-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-evaluated 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 price reduction of the unrated varieties in the whole country has become an inevitable result - according to incomplete statistics, Beijing, Shanghai, Tianjin, Shaanxi, Shanxi, Hainan, Heilongjiang and other places have launched the gradient price reduction of the selected drugs To some extent, a variety if not evaluated, the price reduction can only temporarily keep the market, with their own variety consistency evaluation full of three, will eventually suspend the 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 injection, 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 entry threshold and survival, because only over the 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 drug company owners will be taken lightly From the enterprise's point of view, the cost of a consistency evaluation? Sunken costs? He won't calculate the sunken costs into the operation, nor will he give up on the price The impact of volume procurement on the sale of pharmaceutical products permeates every link, especially the unrated varieties Taking the implementation results of the 4 plus 7 as an example, 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 that: the national belt procurement is mainly targeted at three and above over-evaluation varieties, relatively included products will not be too much, because there is a certain technical threshold, after all, the products in the national approval number, or a very small part However, provincial belt procurement does not need the technical threshold of consistency evaluation, basically is the province's winning bid or network enterprises with a relatively large volume, occupying more medical insurance funds of products 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 sales cash flow products, will actually 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