The market structure will change! 8 varieties of 9 pharmaceutical companies including Zhengda Tianqing, Hausen, Jialin, and Huahai were approved and passed the consistency evaluation

This is the fourth batch of products that have passed the conformity assessment since the implementation of the quality and efficacy conformity assessment policy for generic drugs So far, a total of 25 varieties and 45 specifications have passed the consistency evaluation On May 22, the State Drug Administration issued the announcement on the conformity evaluation of quality and efficacy of 12 varieties of atorvastatin calcium tablets through generic drugs (the fourth batch), announcing that 12 specifications of eight varieties including atorvastatin calcium tablets passed the conformity evaluation Among them, there are 9 companies including Zhejiang Huahai, Zhengda Tianqing, Shanghai deseno biology, Zhejiang Jingxin, Beijing Jialin, Jiangxi Qingfeng, Hunan Dongting pharmaceutical, Sinopharm Ouyi, Jiangsu Haosen, etc This is the fourth batch of products that have passed the conformity assessment since the implementation of the quality and efficacy conformity assessment policy for generic drugs So far, a total of 25 varieties and 45 specifications have passed the consistency evaluation It is worth noting that among the varieties passing the consistency evaluation, except nevirapine tablets of Zhejiang Huahai and efaviron tablets of Shanghai desino biomedical Co., Ltd belong to the products in "289 base drug catalog", the rest are all non 289 catalog products This law is also reflected in the past through the product catalog Among the 31 specifications, 20 products are non 289 catalog varieties, only 11 of which are in the "289 base drug catalog" 1 The market competition pattern will change With the emergence of a new batch of generic consistency evaluation varieties, the new market competition pattern is believed to come soon Taking Beijing Jialin atorvastatin calcium tablet as an example, there are two different specifications, 10mg and 20mg, which have passed the consistency evaluation The original product is Pfizer's heavy bomb "Lipitor" According to Dongfang Securities Research Report, 20mg products are the mainstream drugs in the market at present, accounting for 85.74% of the market share However, according to the data of the first three quarters of PDB, the sales volume of carling's "Arle" in this specification is not large, accounting for only 11.91% of the sales volume Therefore, through the consistency evaluation this time, Arle will undoubtedly form an advantage in the field of 20mg, to carry out the original research and replacement In terms of 10mg drug use, the market share of aloe has been ahead of other enterprises, accounting for about 49.35%, which is higher than Lipitor Therefore, the consistency evaluation will help to build a deeper moat The same is true for entecavir dispersible tablets of Zhengda Tianqing and entecavir capsules of Qingfeng, Jiangxi As a heavyweight product in the field of hepatitis B virus resistance, entecavir has a market space of up to 10 billion yuan According to the World Health Organization's global hepatitis report 2017, the number of people infected with hepatitis B or C in the world has exceeded 325 million In China, the number of chronic hepatitis B virus carriers has reached about 120 million There are 30 million patients, only 2 million people have been treated, less than 1 / 10 of the total Hepatitis B is still the first infectious disease in China According to the data of drug use in domestic sample hospitals, the sales of entecavir in China exceeded 100 million yuan in 2007, and the sales growth was slow in the next few years Until 2014, the sales finally exceeded 1 billion yuan (＞ 1.2 billion), and by 2016, the sales exceeded 1.71 billion yuan In the past ten years, the market has increased 46.5 times, showing outstanding performance in the domestic market of nucleoside antiviral drugs, becoming the leading heavy product in the market of Antihepatitis B drugs In the field of competition, China and the United States, Shanghai Squibb's boluting has always been in a leading position In domestic enterprises, although many local pharmaceutical enterprises have entecavir products listed, the most competitive advantages are actually Zhengda Tianqing and Jiangxi Qingfeng In the market competition in 2017, both Zhengda Tianqing and Jiangxi Qingfeng tend to reduce product prices and trade prices for volume According to the data, the maximum price reduction of Zhengda Tianqing products is 38.8%, lower than that of Jiangxi Qingfeng by 50.2% However, in 2017, the number of winning provinces reached 27, higher than that of Jiangxi Qingfeng by 23, reflecting a strong market competitiveness and price maintenance ability In 2017, the sales volume of chinda Tianqing entecavir in China reached RMB 3.169 billion In addition, there are schizophrenia drugs olanzapine tablets In total, two enterprises passed the consistency evaluation, namely, Jiangsu Haosen and Jiangxi Qingfeng The original research drug of the product is Zyprexa, a schizophrenic drug in the United States Its annual sales reached US $2.5 billion during the subversive period, but the sales fell precipitously after the patent expired in 2012 2 Policy implementation is the key Not long ago, the focus interview said in the special report on generic drugs: this new policy is to promote domestic generic drugs and expand imported drugs It can be said that it is a big game to force pharmaceutical enterprises to reform and innovate and enhance competitiveness It is no doubt that the gradual implementation of the consistency evaluation policy of generic drugs is an important means to promote the development of domestic generic drugs The key to success lies in how the conformity evaluation policy of generic drugs is implemented? What will be the future status of these products in centralized procurement, market bidding and medical insurance access? First of all, it can be clear that from the perspective of the bidding rules that have been successively disclosed in many places, the vast majority of provinces have made it clear that "varieties through consistency evaluation" and the original research products are in the same bidding group Guojin Securities said in its research report that the advantage is that the share of the original research will not disappear in a short time, but the price of domestic varieties will not be dragged down For a large number of old varieties of manufacturers, the long tail market share is huge, and it is expected to increase with the rule of "more than 3 manufacturers of the same variety of drugs passing the consistency evaluation, and no longer select the varieties failing the consistency evaluation in the centralized purchase of drugs" At present, there are three varieties that have passed the consistency evaluation, such as tenofovir On December 5, 2017, China biopharmaceutical announced that tenofovir dipivoxil fumarate tablet developed by Zhengda Tianqing has obtained the drug registration approval issued by CFDA, and has become the first generic drug in China to complete the bioequivalence research according to the "quality and efficacy consistency evaluation of generic drugs" standard, and through the head-to-head clinical trial with the original research drug The corresponding products of Chengdu Beite and Qilu pharmaceutical have passed the consistency evaluation successively, so the competition pattern of the original + 3 consistency evaluation varieties of tenofovir has been formed
Another good news is that with the list of varieties that have completed the consistency evaluation coming out one after another, many regions have begun to enter the stage of online procurement of varieties that have passed the consistency evaluation For example, Shanghai Sunshine pharmaceutical procurement platform has released the second batch of drugs that have passed the consistency evaluation and started online procurement, and Liaoning provincial centralized procurement office of drugs and consumables also released on April 18 The notice on launching new approved innovative drugs, evaluating generic drugs through consistency of quality and efficacy, and directly online purchasing of generic drugs negotiated by the state was issued Gansu, Heilongjiang, Shaanxi, Jiangsu and other places have also issued documents in recent years to encourage medical institutions to use varieties that pass the consistency evaluation, and to purchase and use them preferentially on the basis of enjoying the same treatment of the original research or appropriately reducing the price But this trend is not absolute, and not every place has adopted similar encouraging policies For example, Foshan Municipal Bureau of human resources and social security issued a notice on April 26, saying that it clearly did not adopt the proposal of "increasing drug varieties that pass the consistency evaluation, and medical institutions should give priority to purchasing and clinical selection", and that "clinical selection of medical institutions should be respected" In terms of the most critical pricing, the information of Guojin securities shows that at present, from the perspective of the procurement rules of various regions, Shanghai, Inner Mongolia Autonomous Region, Jilin, Hubei, Qinghai and other places have the basis for price increase For example, the Inner Mongolia Autonomous Region stipulates that enterprises can negotiate with medical institutions directly, with prices from other provinces as a reference, Jilin stipulates that "purchase prices shall be negotiated by themselves", and Hubei states that medical institutions shall give priority to purchase and use varieties that pass the consistency evaluation But we must also see that this kind of pricing freedom does not mean that enterprises can safely set high prices Then there are "national linkage", "dynamic adjustment" and so on Therefore, although the harvest period of generic conformity assessment is far ahead, there is a long way to go before we can really get there.