Count the "first time" of Chinese pharmaceutical industry in 2019

This is the best time This is also the most challenging time For China's pharmaceutical industry, 2019 can be regarded as an epoch-making year to some extent China's local castles in the air began to enter a substantive stage of development in 2019, when the new drug was listed on the stock market What we see is the surging demand for production In the past few years, the capacity reserved by major enterprises began to play its role in succession With a large number of innovative pharmaceutical enterprises in the critical period of transition from clinical stage to commercialization, a number of cdmo enterprises began to undertake a large number of orders What we see is that many products are expected to be able to submit new drug applications within the next 1 to 2 years What we see is that the commercialized team has been established, and the demand for commercialized talents has gradually exceeded the demand for R & D talents In 2019, a group of companies began to embrace the capital market intensively Science and technology innovation board opened, 26 pharmaceutical manufacturing companies have been queuing for IPO Zejing biology became the first company to adopt the fifth set of listing standards under the new deal of science and technology innovation board and successfully passed the meeting The micro core biology, which attracted much attention, rose 511.85% in opening From the second half of 2018 to 2019, the new deal of Hong Kong Stock Exchange officially ushered in a climax A number of unprofitable biotechnology companies, such as kangxinuo, Yasheng pharmaceutical and kangningjierui, have been listed on the Hong Kong Stock Exchange successively, and the capital market has responded enthusiastically At the same time, when the whole industry investment and financing is in decline, the target of pharmaceutical projects still presents the trend of resistance cycle in 2019 In 2019, China's pharmaceutical industry also began to move towards the global advanced road: China's biopharmaceutical and Hengrui pharmaceutical were listed in the top 50 global pharmaceutical enterprises in 2019; brukinsa, a Btk inhibitor independently developed by Baiji Shenzhou, was approved by FDA for listing, bringing "zero breakthrough" for China's original new drugs to sea In addition, from the perspective of policy, the second expansion of procurement with volume was officially implemented, and the number of new drugs included in the pharmaceutical negotiation has set a historical record On the one hand, generic drugs will face a huge impact in the future On the other hand, the rise and catch-up of domestic innovative drugs have formed new forces of innovation It can be predicted that the market pattern in the next few years will be a state of near reconstruction On June 11, 2019, pharmaceutical exec magazine published the top 50 global pharmaceutical companies in 2019 Compared with the 2018 ranking, there is no obvious floating change in the overall list Among them, BMS, Takeda, shire, youshibi and other companies ranked higher, while Gilead, Erjian, TIWA, Indian sun pharmaceutical, Irish generic companies Endo, and Vang Lingke saw a relatively significant decline Pfizer topped the list for four consecutive years, with prescription drug sales of US $45.302 billion, Roche and Novartis ranked second and third respectively, and prescription drug sales reached more than US $43 billion It is worth noting that for the first time, Chinese pharmaceutical companies have appeared in this list China Bio pharmaceutical and Hengrui pharmaceutical rank 42nd and 47th in the list with the sales of prescription drugs of US $3.142 billion and US $2.57 billion respectively The reason for concern is that the shortlist of China biopharmaceuticals and Hengrui pharmaceuticals has begun to show the possibility of changes in the revenue structure of Chinese pharmaceutical enterprises to some extent A generally accepted figure is the market share of innovative drugs and generic drugs in the Chinese pharmaceutical market, which is about 5%: 95% However, most of the top 50 multinational pharmaceutical companies in terms of sales volume of prescription drugs over the years rely on the huge sales volume accumulated by innovative drugs China biopharmaceutical and Hengrui pharmaceutical, to a certain extent, represent that enterprises transforming from traditional Chinese pharmaceutical enterprises to innovative ones can be shortlisted, which points out a direction for the development of Chinese pharmaceutical enterprises in the future Pharmaceutical enterprises that can match the international level must no longer be companies that rise on the basis of generic drugs Who can fully tap the market dividend of innovative drugs and patent drugs, Who really has the say in the market On November 14, 2019, the U.S FDA announced that brukinsa, a Btk inhibitor independently developed by Baiji Shenzhou, was approved for marketing as an accelerated treatment for adult mantle cell lymphoma (MCL) patients who had received at least one treatment before This is the first new anti-cancer drug that has been independently developed by Chinese enterprises and approved by FDA, which has brought "zero breakthrough" to the sea Before that, it was not easy for Chinese pharmaceutical companies to rush to FDA As the "international benchmark of traditional Chinese medicine", Tianshili holds the "shoulder handle" - Compound Danshen dropping pill, which is sold in the domestic Chinese patent medicine market However, since the end of 1997, the compound Danshen Dropping Pill officially passed the FDA ind (clinical trial application), it has been on this road for more than 20 years In recent years, it has been pushing forward the process of rykindo, a slow-release microsphere muscle injection product, which is also the leading green leaf pharmaceutical company in China On March 28, 2019, it officially submitted its new drug application to the FDA of the United States, becoming the first innovative drug preparation submitted by Chinese Pharmaceutical companies to the FDA of the United States However, at present, the progress is not as good as that of BTK inhibitors in Baiji Shenzhou, for example This is swift As the development theme of China's pharmaceutical industry gradually changes from imitation to innovation, pharmaceutical innovation has become the core power to support the future development of enterprises Especially in recent years, domestic pharmaceutical companies have invested heavily in R & D, and the gap with the international level has gradually narrowed Baiji Shenzhou invested 4.557 billion yuan in R & D in 2018, which is the highest in China, followed by Hengrui's 2.67 billion yuan It is estimated that the R & D expenditure in 2019 will exceed 3 billion yuan Fosun and China biopharmaceutical followed closely, with R & D expenditure of 2.507 billion and 2.088 billion respectively in 2018 Zebutini, as the first Chinese indigenous anti-cancer drug approved to be listed in the United States, will boost the confidence of Chinese pharmaceutical enterprises on the international stage, and it is also an important start for Chinese indigenous medicine to accelerate its entry into the international market On February 25, 2019, the website of the State Drug Administration announced that the first domestic bio similar drug, rituximab injection (trade name: hanlikang), was approved for marketing, mainly for the treatment of non Hodgkin's lymphoma This product is developed by Shanghai Fuhong Hanlin Biological Pharmaceutical Co., Ltd Due to the characteristics of manufacturing process and molecule itself, it is difficult for Biomacromolecule drugs to achieve the same structure and function as the original drugs, so they are called biological similar drugs At the same time of encouraging innovation, in order to minimize the burden of patients, the world's major pharmaceutical powers are encouraging the research and development of biological similar drugs to improve the accessibility of biological drugs Song Ruilin, President of China pharmaceutical innovation promotion association, once said: "for China, the first biological similar drug hanlikang has been approved, which is of great significance in the process of pharmaceutical innovation Today, China's development of bio similar drugs is only three or four years behind that of Europe and the United States, which makes us confident in the innovation and development of China's pharmaceutical industry " The good news came one after another In the second half of 2019, the State Drug Administration approved the listing registration application of adamumumab injection (trade name: gelleli) developed by biotherapeutics Co., Ltd and bevacizumab injection (trade name: andak) developed by Qilu Pharmaceutical Co., Ltd It is worth noting that the original research of adamumumab injection developed by baiaotai is xiumeile, the world's "drug king", with a global sales revenue of 20.5 billion US dollars in 2018 Since 2019, xiumeile has successively applied for price reduction in Jiangxi, Beijing, Shaanxi and other places The price of 40mg / 0.8ml/piece has been adjusted from 7608.38 yuan to 3160 yuan, a drop of 60% This year, xiumeile also successfully entered the medical insurance catalog through negotiation, hoping to seize the opportunity through price preemption Up to now, three biologically similar drugs have been successfully listed in China This means that in the market competition for "heavyweight star anticancer drugs", more and more local enterprises are breaking through the encirclement and seizing the opportunity On November 2, China's State Drug Administration released a message that it was conditional to approve the application for listing and registration of the new Alzheimer's disease drug, ganlute sodium capsule (gv-971, trade name "nine phases one") The drug is jointly developed by Shanghai Pharmaceutical Research Institute, Ocean University of China and Shanghai Green Valley Pharmaceutical Co., Ltd with full independent intellectual property rights, and is the world's first innovative drug for multi-target treatment of Alzheimer's disease Nine phase one went on the market for a while, and brushed the screen in the medical circle It has been a difficult problem for the medical community to know how to treat Alzheimer's disease In the past few decades, many anti ad drugs developed by famous pharmaceutical companies in the world have failed in phase III clinical trials, so that no new drugs have been put on the market However, when the public applauded the approval of the new drug, some experts and scholars put forward some different ideas on its clinical trial design, principle and mechanism, test data, historical products of Green Valley, etc Perhaps to some extent, the "questioned" of the first phase of the ninth phase is just the pain point of Chinese new drug research and development, and also gives Chinese new drug research and development enterprises a wake-up call, that is, how to improve the quality of Chinese pharmaceutical innovation, how to solve the problem of the lack of specialization of Chinese clinical trial talents, how to reduce the investment, training, management, standardization and other aspects of clinical trials to the international level The gap On October 28, 2019, the stock price of Hengrui Pharmaceutical (600276 SH) hit a record again, reaching a record high of 91.15 yuan / share in the intraday trading, and the market value exceeded 400 billion yuan for the first time By the end of the day, the share price was 91.08 yuan / share, up more than 4%, with a market value of 402.8 billion yuan, or about $57.09 billion, surpassing world-famous pharmaceutical companies such as Elgin, Baijian, and Takeda, and entering the top 20 in the world Compared with 289.4 billion yuan at the end of the first quarter of 2019, the market value of Hengrui has risen by more than 100 billion yuan, once again refreshing its market value record This is also the market value height that domestic pharmaceutical enterprises have never reached up to now According to Guosheng securities, looking at the dimension of 10 years, changes have taken place in the domestic drug use structure brought about by the encouragement of innovation, the leading group has been upgraded intensively, and Hengrui medicine is far from the ceiling In fact, the position of the company with a market value of 100 billion yuan in the pharmaceutical sector is not easy to sit on On June 30, 2018, Kangmei Pharmaceutical Co., Ltd ranked the fourth listed company in the pharmaceutical sector with a total market value of 113.8 billion yuan More than a year later, Kangmei after the explosion was labeled as "ST" and faced the risk of delisting And Fosun Pharmaceutical also dropped from 100.8 billion yuan to 67.8 billion yuan, with its market value almost halved The reason why Hengrui is favored by the capital market is nothing more than its better performance growth, profitability and considerable expectation in the future With the harvest of innovation achievements and the large amount of new drugs on the market, Hengrui's valuation has been improved For thousands of pharmaceutical enterprises, how to choose the development path in the new era of change is also a very realistic problem On May 7, 2019, the State Food and Drug Administration issued a notice: the first long-acting GLP-1 weekly hypoglycemic drug, pegylated loseptide (freimer), independently developed by hausen pharmaceutical, was listed in China As a large country of diabetes, China has more than 100 million patients, more than a quarter of the total number of patients in the world However, most of the existing diabetes drugs in the Chinese market are traditional drugs, and many multinational pharmaceutical companies have laid out innovative drugs such as DPP-4 inhibitors, GLP-1 receptor agonists and sglt-2 inhibitors It is worth noting that GLP-1 receptor is activated