A-le is the first to pass the consistency evaluation, and the 10 billion market will be shuffled. Who is the next breakthrough?

Wonderful content on May 15, Dezhan health released a notice that its subsidiary, Beijing Jialin Pharmaceutical Co., Ltd., recently received the approval document for supplementary application of atorvastatin calcium tablets (trade name: alo) issued by the State Drug Administration, which means that alo has officially passed the consistency evaluation of generic drugs According to statistics, the total market of atorvastatin has exceeded 10 billion yuan Its huge market potential and superior competition pattern attract many pharmaceutical companies to scramble for "tickets" and enjoy the policy dividend Up to now, there are 11 pharmaceutical companies applying for the consistency evaluation of atorvastatin calcium tablets In addition to the outstanding Beijing Jialin pharmaceutical industry, who will become the next breakthrough?   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> the first to pass the consistency evaluation and enjoy the policy dividend first On April 3, the general office of the State Council issued the opinions of the general office of the medical reform office of the State Council on reforming and improving the supply guarantee and use policy of generic drugs The opinions clearly and comprehensively implemented the follow-up landing policy of products through consistency evaluation, and gave full support to excellent generic drugs in terms of procurement, medical insurance, tax, publicity, etc As the first atorvastatin calcium tablet to pass the consistency evaluation, the company will obtain certain support in drug bidding and medical insurance payment Arle of Jialin Pharmaceutical Co., Ltd is the first domestic generic of Lipitor of Pfizer It was approved for listing in 1999 and enjoys 8-year administrative protection period Since 2001, Jialin pharmaceutical has started the bioequivalence test for aloe Up to now, the company has completed five bioequivalence tests for aloe It is no accident that the energy rate passed the consistency evaluation first According to the 2017 annual report of Dezhan health, Jialin pharmaceutical achieved a net profit of 803 million yuan in 2017, with the annual sales volume of its main product, alo, of 173 million boxes, contributing more than 90% of the company's performance Now alo has passed the consistency evaluation, which is conducive to promoting its market sales, improving its market competitiveness, and having a positive impact on the company's business performance   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> there are 20 billion markets for antilipidemic drugs, and statins are the top ones Figure 1: the market of terminal antilipidemic drugs for public medical institutions and urban retail pharmacies in China from 2015 to 2016 (unit: 100 million yuan) (source: minenet database) Atorvastatin is mainly used in the treatment of hyperlipidemia In recent years, the number of hyperlipidemia patients in China has remained high, and the domestic market for antilipidemic drugs has grown rapidly According to the data of minenet, in 2016, the total market of antilipidemic drugs for the terminals of China's urban public hospitals, county-level public hospitals, urban community centers, township hospitals (referred to as China's public medical institutions) and China's urban retail pharmacies was 23.275 billion yuan, including 19.53 billion yuan for the terminal drug market of China's public medical institutions, an increase of 14.62% over the previous year; and the city retail of China The terminal drug market of drugstores was 3.745 billion yuan, up 11.76% year on year Figure 2: in 2016, the top 20 products of Chinese public medical institutions' antilipidemic drugs (source: the competition pattern of China's public medical institutions in minenet) in the end of China's public medical institutions, statins developed rapidly and dominated the first-line market Among the top 20 products of antilipidemic drugs, atorvastatin leads the market with 44.68% market share, rosuvastatin calcium takes the third place with 21.53% market share, atorvastatin calcium capsule takes the third place with 8.64% market share, and the three products account for 74.85% of the total market share, of which the total market share of the two dosage forms of atorvastatin is 53.32%, and "banbijiang" is divided into the market of antilipidemic drugs Mountain "   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> the market concentration of atorvastatin is high, and 6 pharmaceutical companies compete for 10 billion space Figure 3: the market of atorvastatin for public medical institutions and terminal of urban retail pharmacies in China from 2015 to 2016 (unit: 100 million yuan) (source: intranet database) According to the data of minenet, in 2016, the total market of atorvastatin at the terminals of public medical institutions and urban retail pharmacies in China was 12.616 billion yuan, of which the market of atorvastatin at the terminals of public medical institutions in China was 10.475 billion yuan, up 15.56% year on year, and the market of atorvastatin at the terminals of urban retail pharmacies in China was 2.141 billion yuan, up 12.2% year on year 。 Table 1: competition pattern of atorvastatin brand of public medical institutions in China in 2016 (source: minenet competition pattern of public medical institutions in China) Atorvastatin has a high market concentration At present, there are only six manufacturers, namely Pfizer, Beijing Jialin pharmaceutical, Tianfang pharmaceutical, Zhejiang xindonggang pharmaceutical, Guangdong encyclopedia pharmaceutical and Slovenian LECO Their market shares are 58.10%, 23.27%, 16.11%, 1.36%, 0.58% and 0.58% respectively The original research manufacturer Pfizer's Lipitor dominates the market, and there is a large space for import substitution Beijing Jialin pharmaceutical's Arle still has a large potential for substitution Figure 4: atorvastatin specification pattern of Chinese public medical institutions in 2016 (source: minenet competition pattern of Chinese public medical institutions) At present, there are three specifications of atorvastatin in the market, namely 10mg, 20mg and 40mg The market share of atorvastatin with 20mg is about 74.75%, which is the most mainstream drug specification at present The market share of atorvastatin with 10mg is about 25.23%, and that of atorvastatin with 40mg is only 0.02% In 2016, at the end of China's public medical institutions, 6 enterprises all produced 10mg of atorvastatin, of which Beijing Jialin Pharmaceutical Co., Ltd had a sales volume of 1.221 billion yuan, which exceeded Pfizer's Lipitor and was in a leading position; In terms of 20mg specification, Lipitor occupies a large market share, with sales volume of 6 billion yuan in 2016, while the sales volume of Arle is not large, so in terms of 20mg specification, Arle still has a large alternative space, which is also the main battlefield of Arle in the future     none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; Color: rgb (62, 62, 62); border style: none solid; text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> consistency evaluation is the next breakthrough? According to the State Council, drugs that have passed the consistency evaluation should be properly supported in the payment of medical insurance, and medical institutions should give priority to purchasing and selecting drugs in clinical practice If there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, no more varieties that have failed the consistency evaluation will be selected for centralized purchase of drugs It can be seen that the high-quality generic drug manufacturing enterprises that have made rapid progress in the consistency evaluation will take the lead and usher in significant benefits This time, Alec took the lead in passing the consistency evaluation, and the opportunity for the latecomers is narrowing Table 2: filing status of reference preparation for consistency evaluation of atorvastatin calcium tablets (source: reference drug information database of minenet) According to minenet reference drug information base, in addition to Beijing Jialin Pharmaceutical Co., Ltd., there are four enterprises that record the reference preparation of atorvastatin calcium tablets, including Zhejiang xindonggang Pharmaceutical Co., Ltd., Shijiazhuang Huaxin Pharmaceutical Co., Ltd., Shanghai Novartis Trading Co., Ltd and Dezhou Dezhou Dezhou Pharmaceutical Co., Ltd According to the filing of dosage forms, atorvastatin calcium tablets of 10mg, 20mg and 40mg have been filed Table 3: be test of atorvastatin calcium tablets consistency evaluation According to the data of China drug clinical trial publicity database of minenet, at present, in addition to Beijing Jialin pharmaceutical which has passed the be test of atorvastatin calcium tablets, there are 10 manufacturers, among which only Zhejiang xindonggang pharmaceutical has made the reference preparation record, and only the company's atorvastatin calcium tablets are the consistency evaluation record products   According to the 2.0 data of China drug review database on minenet, yuliping of Zhejiang new Donggang Pharmaceutical Co., Ltd has submitted the drug supplement application, which is currently in the state of review and approval It is believed that in the near future, it will become the second atorvastatin calcium tablet that has passed the consistency evaluation, and will seize the market together with Lipitor and aloe, although Zhejiang new Donggang Pharmaceutical Co., Ltd also sells 20 mg varieties, From the perspective of market competitiveness, Beijing Jialin pharmaceutical's Arle is better, and the possibility of import substitution is greater in the future Data source: minernet database, annual report of listed companies