[Zhou Jun] 2 new trends of the province or the trend of elimination and price reduction of generic drugs; 4 pharmaceutical enterprises are ahead of others, Hengrui, sunflower, Huasen and guangshengtang

This week's highlights: 1 17 anti-cancer drugs are included in the medical insurance, and the dynamic adjustment mechanism needs to be improved urgently 2 18 anti-cancer drugs have been approved for listing, and will continue to speed up in 2019 3 The favorable policies for rare disease drugs continue, and 21 tax reduction lists have been published 4 The failure to win the bid for "4 + 7" centralized purchase of "high-priced drugs" has been suppressed Is it a good policy for enterprises to take the initiative to reduce prices? 5 Without review, 64 pharmaceutical companies have been banned by many provinces 6 4 pharmaceutical companies have been suspended from purchasing 17 anti-cancer drugs from Hengrui, sunflower, Huasen and guangshengtang industries have been included in the medical insurance The dynamic adjustment mechanism needs to be improved On February 19, the State Council's regular policy briefing revealed that through the dynamic adjustment of medical insurance, 17 kinds of anti-cancer drugs had been included in the category B scope of national medical insurance through negotiation in 2018 As of November 2018, all provinces have carried out online procurement and medical insurance payment according to the negotiation results By the end of December 2018, the total purchase volume of medical institutions and pharmacies across the country is about 1.84 million pills / tablet / piece, which is a large statistical caliber The total purchase amount reached 562 million yuan, saving 918 million yuan compared with the price before negotiation Next, the medical insurance bureau will carry out its work from two aspects: first, to study and improve the management methods of the scope of use of basic medical insurance, to make clear provisions from the basic conditions of drug access, the review procedures of experts and the negotiation procedures, and to clearly establish a dynamic adjustment mechanism of drugs in this document; second, to carry out the adjustment of the medical insurance drug catalog in 2019 18 anticancer drugs have been approved for marketing, and will continue to speed up in 2019 On February 19, the regular policy briefing of the State Council revealed that in 2018, 18 new anti-cancer drugs approved by the State Food and drug administration increased by 157% compared with 2017, through such policy measures as canceling the port inspection of imported chemicals, simplifying the approval procedures of new drugs abroad, optimizing the approval procedures of clinical trials, and establishing a special review mechanism for new drugs abroad urgently needed in clinical The approval speed has also been halved Before 2018, the average time spent in the approval of new anticancer drugs in China was 24 months, while the average time spent in 2018 was about 12 months, which is also in line with the approval speed of developed countries In 2019, the State Food and Drug Administration will continue to deepen and improve the above-mentioned effective measures, and continue to speed up the implementation of supporting policies and accelerate the listing process of new anti-cancer drugs The favorable policies for the use of drugs for rare diseases continue 21 tax reduction lists have been published recently The first batch of 21 drugs for rare diseases and 4 API tax reduction lists have been released, involving bosentan tablets, alisentan tablets, megestat, etc From March 1, the 21 drugs will be subject to value-added tax at a reduced rate of 3% for the import of anti-cancer drugs, and 3% for the domestic links The tax reduction is only a small step As early as June 2018, the national health and Health Commission and other five departments jointly released the first list of rare diseases, including 121 diseases With the publication of the first batch of rare diseases, analysts believe that the special list of drugs for rare diseases, the priority review and approval of related drugs, medical insurance and other policies will be accelerated It is reported that at present, the medical insurance bureau has included the exclusive patented drugs for the treatment of multiple sclerosis, hemophilia and other rare diseases into the medical insurance drugs through negotiation In the future, it will gradually include the rare disease drugs with definite curative effect and can be undertaken by the medical insurance fund into the medical insurance payment scope In addition to reducing drug prices, on February 15, the national health and Health Commission has deployed the establishment of a national collaborative network for diagnosis and treatment of rare diseases It is clear that it will establish a smooth and perfect cooperation mechanism, carry out relatively centralized diagnosis and treatment and two-way referral for patients with rare diseases, improve the comprehensive diagnosis and treatment capacity of rare diseases in China, gradually achieve the goal of early detection, early diagnosis, treatment and management of rare diseases, and announce 324 hospitals in the first batch As a collaborative network hospital 12 drug transfer: pediatric chaigui antipyretic granules, dingkundan, Yinhuang granules On February 19, the announcement on adjusting 12 drug management categories such as Bushen Runfei oral liquid (No 10, 2019) issued by the State Food and drug administration showed that 12 kinds of drugs were converted from prescription drugs to over-the-counter drugs, and the instructions would be revised accordingly after being transferred to over-the-counter drugs However, the 3 double span varieties involved: dingkundan, honeysuckle soft capsule and Xinnaoxin pill can continue to be used It is reported that almost all of the 12 varieties of over-the-counter drugs are commonly used products, such as Xiaoer chaigui antipyretic granules and Yinhuang granules, which are more common at home It is believed that after being converted to over-the-counter drugs, the sales path will be wider and the sales volume will be larger The "4 + 7" centralized purchase "high price medicine" failed to win the bid in the procurement hot spot was suppressed Is it a good strategy for the enterprise to take the initiative to reduce the price? On February 19, Shanghai Sunshine pharmaceutical purchasing network officially released the notice on the work of the pilot project of centralized purchase and use of drugs organized by the state In order to ensure the quantity of "4 + 7" winning varieties, Shanghai will adjust the payment standard of medical insurance this time, and increase the proportion of general name of pilot varieties of centralized drug procurement organized by the state and the proportion of self payment of individuals using the same variety of "high price drugs", with the maximum increase of 20% This is another bright spot in all the 4 + 7 volume purchasing policies issued by Beijing, Fujian, Tianjin and Liaoning It is worth noting that "high price medicine" is a key keyword to increase the proportion of self pay If the promised price of the enterprise's price reduction reaches the bid winning price, the proportion of self payment will not be increased From this point of view, Shanghai's policy for unsuccessful products is still to encourage enterprises to "reduce prices" Previously, the unsuccessful varieties actively applied for price reduction, and only Qilu pharmaceutical's gefitinib tablets and Hengrui's dexmedetomidine hydrochloride injection were lower than the bid price of volume procurement Although this is only a relevant policy issued by Shanghai, Shanghai has always been a pioneer, innovator and demonstrator in the "4 + 7" volume procurement I believe that this policy will spread rapidly in other pilot cities, so for unsuccessful enterprises, it may be a good policy to choose to reduce prices actively like Qilu and Hengrui Many provinces have blocked the purchase of 64 varieties of pharmaceutical enterprises Recently, Heilongjiang provincial centralized drug purchase network released the announcement on suspending the qualification of online drug transactions of enterprises that fail to pass the conformity evaluation of quality and efficacy of generic drugs The announcement showed that the quality of generic drugs passed the four regulations, i.e amoxicillin capsule (0.25g), escitalopram oxalate tablet (10mg), entecavir dispersible tablet (0.5mg), entecavir capsule (0.5mg) There are 3 manufacturers (up to February 15, 2019) with the consistency evaluation of curative effect The trading qualification of the manufacturers not evaluated in the above product specifications in the provincial drug centralized purchase platform is suspended After simple statistics, 64 enterprises involved are suspended from the network It is reported that Guangdong, Liaoning, Hunan, Jiangxi, Zhejiang, Heilongjiang and other provinces have previously held a non purchasing attitude towards the non evaluated products, and Jiangxi, Heilongjiang, Guangxi and Jiangsu successively announced the suspension of the online qualification of the non evaluated drugs, with a total number of drug regulations of more than 50 This is the second time for Heilongjiang to suspend the qualification of drug manufacturers without conformity assessment Enterprise performance highlights 4 pharmaceutical enterprises are ahead of others This week, Hengrui, sunflower, Huasen and guangshengtang successively released 2018 performance reports 4 The operating revenue of pharmaceutical enterprises has achieved steady growth, and only guangshengtang's net profit has declined by 52.40% In response, guangshengtang said it was due to the rapid surge in R & D investment Recently, Hengrui announced its 2018 annual report, and the company realized operating revenue of 17.418 billion yuan, an increase of 25.89% over the same period last year; net profit of 4.066 billion yuan, an increase of 26.39% over the same period last year The growth of Hengrui's performance in 2018 is mainly due to the three product lines, of which the sales volume of tumor drugs increased by 29.23% compared with last year, the turnover reached 7.39 billion, and the gross profit rate reached 93.35% Hengrui is the largest product sector of Hengrui and one of the main sources of Hengrui's performance revenue In addition, image line products increased by 22.67% and anesthesia line products by 29.25% Among the anti-tumor drugs, apatinib mesylate is a brilliant one, with a year-on-year growth of 68.37% in sales volume, which is one of the fastest-growing products In the next three years, Hengrui anti-tumor drugs, including PD-1 mAb, PD-L1 mAb, AR inhibitor, PARP inhibitor and CDK4 / 6 inhibitor, will be approved successively, becoming the most important driving force for performance growth Sunflower pharmaceutical sunflower pharmaceutical industry notice shows that in 2018, the company's total operating revenue was 4.43 billion yuan, a year-on-year increase of 15.0%; its net profit was 570 million yuan, a year-on-year increase of 33.6%, continuing the high-speed growth trend since 2017 For the reason of growth, the notice shows that the two main products of sunflower pharmaceutical industry, liver protecting tablet and Weikangling, continue to make efforts, and the two gold single products of Xiaoer chaigui antipyretic granules and jinyinhualu have achieved rapid growth According to the Huasen pharmaceutical performance express, in 2018, the company achieved an operating revenue of 7.032 billion yuan, an increase of 18.76% year on year, and an operating profit of 158 million yuan, an increase of 20.94% year on year The main reasons for the growth are the steady growth of the company's product sales revenue and the growth of investment income and other income In 2018, the company's main products are in great demand and both production and sales are booming This is mainly because the company enriches and optimizes the product structure, continues to strengthen market development and strengthen regional marketing control on the basis of consolidating the existing market, so as to realize the continuous and stable growth of the company's sales revenue According to the guangshengtang performance express, the operating revenue in 2018 was 402 million yuan, an increase of 35.87% year on year, and the net profit was 16 million yuan, a decrease of 52.40% year on year The main reason for the decrease of the company's net profit is the increase of R & D investment, including the R & D and consistency evaluation of global first-class innovative drugs During the reporting period, the total R & D investment was 114 million yuan, accounting for 28.28% of the operating revenue, a significant increase of 38 million yuan over the same period of last year Content source: announcement of yaozhi.com, National Health Insurance Bureau, Cyprian blue, public announcement of listed enterprises, e-medicine manager and other statements: this point of view only represents the author, not the position of yaozhi.com, and you are welcome to exchange and supplement in the message area; 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