Strong Hengqiang | 100 billion market capitalization club members increased to 4

Pharmaceutical Network December 25 hearing the reform of the pharmaceutical industry in 2017 is still continuing, 'disruptive' change is a consensus among industry insiders, especially the CPC Central Committee General Office, the State Council General Office issued on the deepening reform of the examination and approval system encourage drug Innovation in Medical Devices, "has a profound impact on the industry, a landmark document that shows people's determination to reform the medical device industry in areas such as innovation and regulation.

In the medical insurance control fee, medicine Against the backdrop of reform in the supply side of the industry, the state's policy reform is in line with the highest international quality standards.During the policy adjustment period, some segments will face adjustments due to the standard upgrade and regulatory tightening, Inevitable, but in the long run, innovative drugs, high quality medicine will be further recognized by the market, and the layout of innovative drugs, high-quality drugs related to listed companies will also be further recognized by the market, the era of strong Hengqiang arrival.

In the year of 2017, the pharmaceutical industry policies are frequent and involve the entire industrial chain of drug research and development, production, distribution and payment, etc. The general trend of policy reform is to accelerate the consolidation of the industry and to conform to the international standards and to reshape the pattern of the pharmaceutical industry.

On October 8, the General Office of the CPC Central Committee and the General Office of the State Council printed the Opinions on Deepening the Innovation of Examination and Approval System for Deepening the Innovation of Medical Devices to Encourage Pharmaceutical Products. The Opinion clearly proposed that the approval of drug and pharmaceutical raw materials and packaging materials should be established and put on the market Drug list to promote the full implementation of the system of marketable permit holders, re-evaluation of pharmaceutical injection and so on, in order to promote industrial restructuring of pharmaceutical and medical devices and technological innovation, improve industrial competitiveness .This opinion is considered as a milestone in China's drug device reform file.

Under the guidance of this document, the State Food and Drug Administration repeatedly issued a number of departments to implement the views of the draft. October 23 State Food and Drug Administration released the "People's Republic of China Drug Administration Law Amendment (draft for comments Draft "), implement the spirit of the above opinions, pay attention to strengthening the life cycle management of pharmaceutical medical devices, cancel the GMP and GSP certification, etc .; November 28, State Food and Drug Administration Drug Evaluation Center (CDE) issued a public solicitation of" China Listed on the listing of chemical products, "the first batch of species included notice of the notice, which is known as the Chinese version of the 'Orange Book'; December 22, CDE released on the public solicitation of" listed generic drugs (injections) consistency assessment Technical requirements "advice notice, this program is mainly focused on drug consistency assessment - injection of re-evaluation.

The intensive policy prompting people to see the determination and speed of government reform in the industry view, this is essentially the supply-side reform of the pharmaceutical industry. Innovative drugs, high-quality medicine more and more attention, and poor quality drugs, fake drugs will gradually be Expelled from the market to meet the people's demand for high-quality medicines and medical services.

If the above series of policies allow biomedical people to see changes in the industry, the implementation of specific policies such as medical insurance control fees will make biomedical industry practitioners feel the pain of the industry.

Earlier this year, Wang Hesheng, director of the Medical Reform Office of the State Council and deputy director of the State Health Planning Commission, said that China will further eliminate the drug replacement mechanism and fully push forward the comprehensive reform of public hospitals and cancel the drug additions. In 2017, the average growth of medical expenses in public hospitals in China Amplitude control in less than 10%, to quantify the growth rate of medical expenses around the country, and implemented to specific medical institutions in the medical insurance control costs, restrictions on the growth of medical expenses environment, the pharmaceutical industry restructuring continues, the industry continued to divide, Super trillion drug market is facing remodeling.

On the one hand, due to the fact that Chinese Herbal Medicine Pieces are not subject to the medical insurance control fee, substantial growth has been maintained. On the one hand, traditional Chinese medicine injections, auxiliary medicines and the like are subject to stringent market controls and market quotas or further squeezing. After the 2016 vaccine incident, in 2017, The overall performance of listed companies pick up; and due to tightening of environmental protection, vitamins and APIs performance dazzling performance.

Under the pressure of medical insurance control fees, more efforts were made to establish a key monitoring drug system, and some regions even announced the list of key drugs under surveillance. Auxiliary drugs, especially the Chinese medicine injection market, are changing.

It is understood that in some hospitals, ancillary drugs accounted for the proportion of ultra-hospital medication, and is the top ten sales in the list of 'regulars'. Insiders said the reason why the higher sales of auxiliary drugs, because of overdose, use.

At the end of this year, a number of regulatory agencies pointed to auxiliary medicine. On December 12, the Guangdong Provincial Health and Family Planning Commission issued the Notice on Establishing the Key Drug Monitoring System for Medical Institutions in the Province. Before that, Beijing, Shanghai and Zhejiang provinces And other places also issued a notice to strengthen the focus on monitoring drug administration, including Guangdong, Beijing, etc., the focus of multi-drug monitoring and control more concentrated sales of products.

Health and Family Planning Commission of Xinjiang Uygur Autonomous Region released the Notice on Establishing Medical Institutions to Supervise the Management of Pharmaceutical Varieties, and clearly pointed out the key monitoring on 39 kinds of medicines.

According to the "Securities Daily" combing, Chinese medicine injection Xinjiang Uygur Autonomous Region Health and Family Planning Commission to monitor the focus, including Danhong injection, Danshen strobolamine, Xiyanping injection, heat poisoning injection, Shenqi Fuzheng injection, Xuebijing Injection, Guantiepi Injection, Shuxuetong Injection, Xingnaojing Injection, Xiaojianping Injection, Shuganin Injection and Tanreqing Injection, among which a number of products are sold Hundreds of millions of Chinese medicine injection varieties.

Medical insurance control costs have affected the sales of enterprise products.Dualing Pharmaceutical announced in the December 20 investor research report said that in December from around the tightening of medical insurance control costs, the company part of the sales of large varieties in some areas Due to the environmental impact of medical insurance control fee policy at the end of the year, sales of some varieties fluctuated by a certain amount. It is understood that the coenzyme of the main product of Shuanglu Pharmaceutical is listed as a key monitoring variety by the XJU Wei Jianwei.

Some auxiliary drug manufacturers began to take the initiative to cut prices.December 7, Zhejiang Pharmaceutical Information Center procurement information show that Beijing Penglai Pharmaceutical Co., Ltd., Haikou Kelly Pharmaceutical Co., Ltd. two companies to reduce the production of phosphate muscle for injection Sodium linkage (purchase) price.While sodium phosphate creatinine is also the Xinjiang Uygur Autonomous Region Health and Family Planning Commission Wei Planning Commission as a key monitoring product.

Analysts believe that the auxiliary drug is also a drug.In this context, the auxiliary drug market will usher in adjustment, is characterized as aided drug products, companies should come up with data to prove its effectiveness, or change its marketing strategy.

Under the pressure of medical insurance control fee, especially in recent years, the international original research drug has entered the peak of the concentration of patents, drug prices become the trend of the times.

The changes in pharmaceutical companies' pharmaceutical strategies can be seen in the number of pharmaceuticals negotiated by the national medical insurance companies, with only three in the first batch of national medical insurance catalogs negotiated in 2016. In 2017, 36 products entered the national medical insurance catalog, most of which were transnational pharmaceutical companies According to figures released by ICSU, the average price of negotiated drugs dropped by 44% compared with the average retail price in 2016, reaching a maximum of 70%. Most of the imported drugs were negotiated at lower rates than those in the peripheral international markets.

Among the 36 drugs successfully negotiated in 2017, there are 31 western medicines and 5 proprietary Chinese medicines, and 15 of the 31 western medicines are oncology therapeutics involving common cancers such as lung cancer, stomach cancer, breast cancer, colorectal cancer, lymphoma and myeloma Species, including trastuzumab, rituximab, bortezomib, lenalidomide; and five are cardiovascular drugs, such as ticagrelor in the treatment of acute coronary syndromes, for the treatment of acute Recombinant human urokinase such as myocardial infarction.

Since then, more provinces and the State Planning Commission and other departments released the information on drug price reduction. Liaoning Province, the State Planning Commission released the information shows that the Pharmaceutical Holdings Limited proxy (Dasatinib tablets) from the original net price of 28,000 yuan / box down to 8548 yuan / box, equivalent to a box of drugs over 19,000 yuan price reduction. Yunnan Provincial Government Procurement Center and the transfer center announced the release of information , Sinopharm Chuan Kang Pharmaceutical Co., Ltd. applied for its production of mycophenolate dispersible tablets from 744 yuan / box to 320 yuan / box, a drop of nearly 57%; Shineway Pharmaceutical (Hong Kong 02877) produced by Salvia Injection The price of liquid dropped from 9.95 yuan / piece to 2.15 yuan / piece, a drop of 78.3%.

Medical insurance control fee - Tender price trend is clear, the pharmaceutical industry in a certain period of time will continue to pressure. 'Tianfeng Securities believes.

Under the general trend of price reduction of medicines, the phenomena of abandoning the mark have appeared in some places.

According to the reporter is not completely sorted out, Shanghai, Hubei, Sichuan, Inner Mongolia, Gansu, Liaoning and other provinces and cities have successively take the initiative to abandon the bid .In December 22nd, Shanghai Sunshine Procurement Network released "2017 Shanghai Medicare fixed-point Medical institutions bidding results dynamic adjustment to be waiver bid public bidders qualified publicity summary table ", there are 6106 kinds of drugs discarded, including Novartis, Bayer, Merck and other well-known pharmaceutical companies. Shanghai is an important drug supply market, the scale of abandoned business scale , Aroused widespread concern in the market.

However, the withdrawal of the drugs involved in the enterprise, but also contains many commonly used drugs, shortages of drugs such as cold tablets, pediatric heat and relieve cough oral liquid, dexamethasone sodium phosphate injection, montmorillonite powder, which are common drugs, low Price of drug varieties.

A pharmaceutical listed company executives told the "Securities Daily" reporter said the move is helpless business, in some places the tender price is significantly lower than the cost of production, enterprises have to give up this market.

However, the one hand, the tender price cut, the phenomenon of enterprises abandoned the standard many times, on the one hand is more information on the shortage of drug warning information.It is understood that, from May 2016, relying on the national platform for drug administration, the government established a national drug shortage Surveillance systems, including the monitoring of sentinel sites targeted at health care institutions and the platform monitoring for provincial centralized sourcing platforms, will be the key to price war between drugs, enterprise profits and market supply.

Drugs flowing from the manufacturer to the hands of patients to go through the layers of fare increase, which led to some drugs price artificially high.In order to rectify the problems in the field of drug circulation, since last year, the state regulatory agencies to adopt more means to implement two votes system (manufacturing enterprises to distribution companies Open an invoice, distribution companies to medical institutions to open an invoice), in order to reduce the cost of drug circulation. State Department issued "on the further reform and improvement of pharmaceutical production and circulation of a number of opinions" (hereinafter referred to as "opinions"). " "Focusing on solving outstanding problems in the field of medicine, we have put forward system reform measures from the perspective of drug production, circulation and use of the entire chain and the entire process of development. We have clearly proposed that we should strive to launch the" two-vote system "of drug purchasing and marketing nationwide by 2018.

With the gradual promotion of the policy, the two-vote system of medicine gradually spread throughout the country.In addition, as a benchmark for the reform, Anhui Food and Drug Administration also released the "public medical institutions in Anhui Province procurement of medical supplies," two votes system "implementation of the views (Trial) ", the" opinion "that the implementation of medical consumables 'two-vote system' of the species for centralized procurement platform for medical centers in Anhui Province high-value medical consumables centralized catalog procurement catalog varieties and gradually expand the scope of implementation. The future supplies two Whether the ticket system will be implemented throughout the country should attract market attention.

Two-vote system of far-reaching impact on the industry, the industry impact on many subjects.Analysts believe that the future pharmaceutical distribution companies in all provinces of the major drug distribution companies will be reduced to 20 to 30, the commercial distribution business will be national and regional circulation Focused, industry reshuffle acceleration, to further enhance the concentration.

The impact of the two-vote system is not only the pharmaceutical business of pharmaceutical companies, but also have an impact on the pharmaceutical companies.A listed company executives to the "Securities Daily" reporter introduced health insurance, hospitals and pharmaceutical production and distribution companies have always had a "triangular debt" relationship, The fund can not be timely to the hospital money, the hospital can not promptly to the drug distribution company payment, distribution companies will not be able to drug manufacturers payment .There is a reality, most drug distributors assume the 'advance' role, by its first to the pharmaceutical manufacturers Under the two-vote system, this model will change, drug manufacturers need to discuss their own payment, the payment cycle will be longer. '' Some pharmaceutical companies due to the impact of two-vote sales channels are also affected the performance of limited .

The integration of medical devices has aroused the concern of the capital market.At present, there are more than 14000 medical devices in the country enterprise , Operating more than 180,000 enterprises.Currently the top ten medical device companies account for only about 10% of the national medical device market share.While the top 10 medical device giants in the world accounted for 36% of the global market share.

The growth history of leading companies is often the history of mergers and acquisitions. Taking the global medical device giant Medtronic as an example, Medtronic has grown in the past 20 years with hundreds of mergers and acquisitions, and the concentration of domestic medical devices needs to be further strengthened.

In addition, with the support of policies and the improvement of domestic R & D, the domestic alternative will be the trend of the times. '' In the past, GPS (GE, Philips and Siemens) dominated the market and now more and more domestic brands are beginning to emerge. ' A medical device industry investors told reporters that domestic alternatives are accelerating.

Mergers and acquisitions, downstream layout, new technologies and so on have all become the focus of capital investment.In addition, artificial intelligence has become the focus of investment in medical devices, in which the artificial intelligence of medical images has high hopes.

November 15, 2017, the Ministry of Science and Technology held a new generation of artificial intelligence development planning and major science and technology project start-up, which will rely on Tencent to build medical imaging a new generation of artificial intelligence open innovation platform in A-share listed companies, Wandong Medical It is understood that, as the country's largest medical imaging platform, Wandong Wan million medical cloud became the first to introduce medical AI into the practical application of remote imaging diagnostic platform in July of this year, Ali Health ( Hong Kong stocks 00241) and Wandong Medical released the medical artificial intelligence 'DoctorYou', the system includes clinical research platform, medical auxiliary detection engine, physician ability training system.

China Everbright Securities (Hong Kong stock 06178) analysis report that the estimated downstream market in China's medical imaging industry is about 220 billion yuan annually in the service-oriented medical imaging downstream industries urgently need to service model innovation in the remote medical imaging diagnosis and independent imaging center fast Enterprises that have sufficient resources will have greater advantages in carrying out intelligent diagnosis of images in the future.

With the continuous promotion of this policy, the output of medical and medical equipment will become an inevitable result. China is home to over 4,000 pharmaceutical companies, but with only less than 80 enterprises 100 products have been approved or registered in the United States, Europe, Japan, etc. The path of internationalization of medical and medical devices in our country is imminent.

Many companies, including Huahai Pharmaceutical, Hengrui Pharmaceutical, Hisun Pharmaceutical and Renfrew Pharmaceuticals, have applied for drug registration in the United States and other countries and the relevant products have obtained FDA approval.

In addition to increasing the internationalization of its own products, some enterprises have also adopted the acquisition of foreign enterprises in order to achieve turn-by-turn overtaking. In October of this year, Fosun Pharma (HK: 02196) announced that it had acquired the company for a total consideration of 7.142 billion yuan Fosun Pharma 74% stake in generic drug firm completed the transaction delivery, which is the largest amount of overseas acquisitions so far FOSUNPHARMA, and so far the largest transaction amount of Chinese pharmaceutical companies overseas acquisitions. With the merger, Fosun Pharmaceutical Manufacturing The internationalization of business will be further accelerated and the market share of pharmaceutical products such as injection will further increase.

On November 29, Nanjing Xinbai issued a plan for assets reorganization and planned to acquire the entire equity interest of Dendreon, a US biopharmaceutical company, from its parent Sanzhou Group for a total consideration of RMB5,968 million after the acquisition was completed and Nanjing New 100 will own the FDA approved the first and only prostate cancer cell immunotherapy drugs Provenge ownership.

Welfare Pharmaceutical announced on May 27 two acquisitions involving the acquisition of 100% equity interests and Jissbon shares in all 6 subsidiaries of the global (excluding China) and other sex business under Ansell Ltd. Upon completion of the acquisition , Human welfare medicine will replace Ansell Ltd., became the world's second largest condom market. June 22, Human Health Pharmaceutical announced the announcement of foreign investment, in order to accelerate the expansion of international business, the company wholly-owned subsidiary of human benefits the United States and BLUE RIDGE Signed a Mutual Investment and Shareholders' Agreement, both parties intending to jointly acquire a 100% stake in RiteDose, a US-based manufacturer of single-dose sterilants using the Blow-Fill-Seal technology Pharmacy manufacturer.

Wadong Medical announced on December 6 that the Company's partnership and Ares Life Sciences LP, the transferor of Yum! Medical Group, respectively signed the Equity Purchase Agreement, which proposed to acquire the entire equity of Yusheng Medical Ex-Treasury shares for 248 million euros. Yum! Medical Group is an internationally renowned high-end medical equipment multinational corporations, the core products include ultrasound medical imaging solutions and dedicated MRI system.In the field of ultrasound imaging, Yum Medical Group mastered the core technology of the whole industry chain, with independent research and development of core components In the international leader in ultrasound contrast, interventional therapy and high-frequency imaging.

Policy adjustments have also affected the capital market investment in pharmaceutical bio-business situation.This year, the pharmaceutical bio-industry secondary market staged a "strong Hengqiang" market.

Flush data show that as of December 22, 2017, the pharmaceutical and bio-industry this year, a total of 42 companies successfully listed A shares, the number of listed annual record high, raising funds amounted to 18.385 billion yuan from the industry breakdown point of view, chemical raw materials There are 5 drug manufacturers, 9 chemical companies, 10 bio-products companies, 3 medical service companies, 8 medical device companies, 2 pharmaceutical business enterprises and 5 Chinese medicine companies. At this point, A-share biopharmaceuticals Industry listed companies rose to 282.

As of December 22, of the 282 listed companies listed above, 103 listed companies have seen positive gains this year, of which 72 listed companies have risen more than 20% this year and 16 listed companies have gained over 100% this year, including Fosun Fosun Pharma, Walson Bio, Chih-Fei Bio, Changchun Hi-tech and other non-IPO companies have risen over 50% this year, with Fosun Pharma numbering 97.5% The increase since the beginning of this year was 90%, ranking second (excluding the IPO data).

'Under the guidance of the policy, the new era of strong oligarchs come.' People in the pharmaceutical industry that Hengrui medicine is known as a research and development of innovative drugs a brother, Fosun Pharma's full industrial chain development mode advantages show.

In the White Horse Unit sought after in 2017, the biomedical sector 100 billion yuan market value club members have also changed.Data show that earlier this year, A stock market value of over one hundred billion yuan only two companies, namely, Hengrui and Shanghai Laoshi, and December 22, hundreds of billions of market capitalization club members become Hengrui, Fosun Pharma, Kangmei medicine, Yunnanbaiyao.

Among them, the market capitalization of Hengrui Medicine rose to 106.0 billion yuan from 106.8 billion yuan, making it the first listed company with a total market capitalization of 200 billion yuan in the biopharmaceutical industry. The market value of Fosun Pharma has doubled this year from 55.1 billion yuan to 113.4 billion yuan The data show that the total market capitalization of Shanghai Laoshi and Huada Genes is almost equal to 100 billion yuan, with the total market capitalization of Shanghai Laoshi being 97.8 billion yuan and the total market capitalization of Huada Genes being 84.4 billion yuan.