Top 10 events in the pharmaceutical industry in 2015

2015 is a special year. This year has always shrouded the cloud of war. The world economy has fallen, oil prices have plummeted, refugees have swarmed into Europe, and terrorist attacks have hit people everywhere. Although there have been frequent news of economic recovery, such as the domestic Double 11 and the US Black Friday rush, the slow and fragile recovery cycle of the global economy has become an indisputable fact. When countries enter the depth adjustment and transition period, they become the world economy. At the time of the new normal, the pharmaceutical industry, which is closely related to the economy, also ushered in a major year of change.

In 2015, there were frequent news in the domestic and international pharmaceutical industries. Tu Hao was awarded the Nobel Prize for artemisinin, the 2015 Pharmacopoeia was introduced, and the mergers and acquisitions of international pharmaceutical companies and domestic medical policies were issued one after another, indicating that this year was not an ordinary one. In 2008, the influence of major policies and news on the industry will be extremely far-reaching. The following author will briefly summarize and sort out the major events that occurred in the pharmaceutical industry this year.

The first is the policy-related major incident. First, the first half of the year to improve the public hospitals centralized procurement of drugs and other documents introduced, clearly the tender implementation of classified procurement, the implementation of the amount of procurement, and the abolition of government pricing, play the role of health insurance control fees and other related work. Subsequent CFDA issued a decision on the revision of the "People's Republic of China Drug Administration Law" and the "medical device classification rules" published in July and other related documents have also been issued in succession, marking that 2015 is a key policy year.

The author puts the above policy for a while and only pays attention to the documents that have frequently been issued in the near future and which are frequently evaluated on generic drugs. First, in August 1998, the 44th State Council issued the “Opinions of the State Council on Reforming the Appraisal, Evaluation, and Approval System for Pharmaceutical Devices”, which proposes improving the quality of review and approval, resolving the backlog of registered applications, improving the quality of generic drugs, encouraging research and creating new drugs, and Improve the overall goal of transparency in review and approval. Subsequent drafting of Guidelines for the Selection and Determination of Reference Formulations for Oral Solid Formulations (Draft for Soliciting Opinions), Guidelines for the Determination and Comparison of Dissolution Profiles for Ordinary Oral Solid Formulations (Draft for Comment), and Quality Conformity of Generic Drugs The technical guidelines for the evaluation of human bioequivalence (Draft for Soliciting Opinions) set the technical implementation targets for the enterprise, and then solicited opinions on the “Opinions on Solving the Backlog of Application for Drug Registration (Policy Opinions for Priority Examination and Approval) (Draft for Comment). The announcement and the solicitation of the “Opinions on Conducting Compliance Evaluation on the Quality and Efficacy of Generic Drugs (Consultation Draft)” have pushed the re-evaluation of generic drugs to a climax.

Subsequently, the CFDA announced 8 companies in accordance with the "Announcement on Conducting Self-Examination and Verification of Drug Clinical Trials" (No. 117 of 2015) and "Announcement on Conducting Self-examination of Drug Clinical Trial Institutions" (No. 197 of 2015). The announcement that 11 drug registration applications were not approved officially opened the curtain for this campaign. The withdrawal of applications for registration of hundreds of drugs of more than 100 companies followed by the policy implementation roadmap.

The second major event was the publication of the draft of the draft for the trial of the drug market listing licensor system and the registration reform of chemical drugs. The November issue of No. 220 [2015] was announced by the CFDA, prompting heated discussions in the industry. The market licensor system, as an internationally more popular system, encourages a strong sense of innovation and can suppress the low level of repetition of pharmaceutical companies from the source. , and further promote the rapid development of China's pharmaceutical industry. However, it also means that the responsibilities of the licensor and the supervisory personnel will be further increased. How to prevent the industry from cohabitation in the current situation of frequent drug safety incidents is the focus of the next step.

The subversive changes in the registration reform of chemical drugs have outlived people's expectations, because the use of drug classification for many years has allowed countless companies that have loved the new drugs to win countless dividends. This reform seeks to be in line with international standards, from the “new China” to the “new global” and the requirement for “improved clinical advantages” for the requirements of improved new drugs. It will exclude pseudo-innovations from new drugs and a series of policy preferences. An innovative person or company puts a bold and bold move forward. For the category 3 to 5 classified as generic drugs, the reporting requirements have also been improved. Special reference preparations must be original research or internationally recognized drugs to ensure that the developed products are consistent in quality and efficacy with the reference preparations. .

The third major event was that October Chinese scientist Tu Yu won the Nobel Prize for medicine for the study of artemisinin. Due to the long-standing Nobel Prizes of the Chinese people, the annual Nobel Prize season has become a national epidemic. From the perspective of the early recognition of the literary awards and medical awards that most people in the hearts of early Chinese nationals had hoped for, and the most difficult to win prizes, the combination of national strength, self-confidence, and Chinese people’s efforts has shown that there is no difficulty in the world. I'm afraid that people are interested. From then on, cutting-edge research will not lack the shadow of China.

In his award-winning speech, Tu Mu said: “Chinese medicine is a great treasure house and we should strive to discover and improve it.” Artemisinin is discovered from this treasure house. Chinese medicine and Western medicine are not superior or inferior, and everyone has their own strengths. The two are organically combined and have complementary advantages. They will have greater development potential. Information collection and accurate analysis are the basis for successful research. About Artemisia Artemisia, the earliest seen in the Han dynasty "Fivety-two disease", followed by "Shen Nong's Herbal Classic", "Additional Lei Gong Gong Fa Bian", "Compendium of Materia Medica" and other classics are records of the treatment of Artemisia annua. The method of extraction of low-boiling solvents suggested by Ge Hong’s “Elbow Reserve Emergency” Malaria Assessing Method makes the antimalarial effective monomer compound “Artemisinin” stand out, and makes tens of millions of malaria patients worldwide Benefit.

On December 9, the State Council executive meeting adopted the "Draft of Traditional Chinese Medicine (Draft)" and will be submitted to the Standing Committee of the National People's Congress for consideration. Experts believe that the "Chinese Medicine Law (draft)" will play a tangible role in revitalizing and inheriting the cause of traditional Chinese medicine, building a medical and health system with Chinese characteristics and a national health protection system, and exploring the use of Chinese-style measures to solve the problem of medical reform.

The fourth major event was published in the 2015 edition of the Pharmacopoeia. In June, the CFDA released an announcement about the release of the “Pharmacopoeia of the People's Republic of China” (2015 edition), which opened the prelude to the implementation of the new edition of the Pharmacopoeia. Since then, various interpretations have come one after another, of which the appendices and accessories have become independent volumes, which constitute the four parts of the Pharmacopoeia. So far, the Chinese Pharmacopoeia has published a total of 10 editions, from early explorations to the second edition of Chinese medicines, and then to the 2005 edition, the “Chinese Biological Products Regulations” has been placed in the Pharmacopoeia as three parts of the Pharmacopoeia. The book is over time. As various improvements continue, the Chinese Pharmacopoeia has started the process of aligning its standards with international standards.

Although experts summarized the list of major seven changes in this edition of the Pharmacopoeia, including the increase in varieties, I believe that the biggest highlight is the increase in the number of accessories, especially the number of accessories for injection use. Due to historical and cognitive reasons, China has always been a big country for injections. Compared with other dosage forms, both Chinese medicine and chemical drugs, injections are among the best in terms of sales volume. In general, chemical injections account for over 60% of the total, and Chinese medicines account for more. Nearly 40%. Due to the large volume, pharmaceutical excipients for injection with high safety risks in pharmaceutical excipients naturally attract attention. The new edition of the Pharmacopoeia increases the number of injection grade excipients, which is of great significance in regulating the domestic huge injection market.

The fifth major event, the merger of Pfizer and Al-Jarge, created a company with a combined market value of over US$340 billion. Some professional organizations predict that the global pharmaceutical market will increase at a rate of 4% to 7% per year over the next five years. Under such circumstances, many pharmaceutical companies have chosen a merger and acquisition strategy. One is to optimize and reorganize their own business structure. The second is to make acquisitions to enter relevant markets. The third is to acquire competitors to consolidate their market position. Of course, there are many other ways to reduce the tax rate by changing the place of registration of the company through mergers and acquisitions.

The purpose of the merger between Pfizer and Al-Jian was to relocate the company’s headquarters in New York to Ireland to avoid tax, and its tax rate is expected to be reduced from the current 25% to 17% to 18%. In July, Xinji acquired Receptos, a US-based biopharmaceutical company, for US$7.2 billion, aiming at a new type of oral S1P1R modulator Ozanimod for the treatment of autoimmune diseases. In November, rare drug company Shire announced that it will acquire Dyax, a rare drug research and development company, for US$5.9 billion, and its intention to dominate in the field of rare diseases is obvious.

The sixth major event, Pfizer and Ayer built the shadow of the big layoffs behind the big deal of the century. Edison Investment Research analyst Maxim Jacobs predicts that the combined company may lay off as many as 10,000 people.

In fact, layoffs often come with mergers and acquisitions. As early as 2009, when Pfizer bought Wyeth, it laid off more than 20,000 people. Not only has the merger triggered a wave of layoffs, but this year GlaxoSmith reduced 40% of Chinese pharmaceutical representatives’ news for bribery incidents, causing a stir in the medical community. Although there are no large-scale layoffs for domestic pharmaceutical companies, it is still not clear how many generic companies can survive the harsh winter after this stringent policy reshuffle, and the shadow of layoffs will always be overshadowed.

The seventh major event, the ups and downs of the stock market on the pharmaceutical listed companies. The ups and downs of the stock market this year can be described as thrilling. The experience of listed companies and investors is equally memorable. However, for pharmaceutical stocks, it is a good landscape. From 2015 until now, pharmaceutical stocks continue to outperform the broader market. The Galaxy Securities Research Department data show that as of November 17, 2015, the pharmaceutical industry as a whole rose. It was 50.27%, far higher than the 13.84% increase in 2014. It was particularly bright for the sectors of medical services, medical devices, and biological products.

As of November 17, the Shanghai Composite Index rose 8%, while the Shenwan Pharmaceutical Index rose 50% over the same period, and only 6 stocks in the industry fell slightly, and the vast majority rose significantly. In the range of gains, the number of pharmaceutical stocks that have risen more than 50% since the beginning of this year reached 115, accounting for 56% of the total pharmaceutical stocks; 17 of which increased by more than 200%, and 50 of which exceeded 100%. Among the companies with more than 400% increase are Guangshengtang, Wanfu Bio, Boji Pharmaceutical, Canaan Technology, Shanhe Pharmaceutical Accessories and Longjin Pharmaceutical. The increase in the stock price of pharmaceutical stocks indicates that the capital market has a high degree of recognition for the valuation of pharmaceutical companies. The listed pharmaceutical companies can obtain more funds for new product development and new business expansion through targeted means of issuance, which will help the industry to gradually get rid of low growth. Repeatedly creating an innovative atmosphere that is actively developing.

The eighth major event was that the orphan drug's heat slowly moved eastward. The fever of orphan drugs has risen in Europe and the United States, and with the large number of orphan drugs gaining great success in the market, this heat has gradually increased. A few years ago, the orphan drugs were very strange to the Chinese people. With the constant promotion of policies and media, the fever of orphans has risen quietly.

In fact, in China, the population of rare patients is very large. However, there is no clear definition of rare diseases in China, which limits the development of other related policies such as rare diseases research, treatment, drug market access, and medical security. Data show that there are less than 100 kinds of orphan drugs that are currently on the market in China, and this phenomenon of excessive diarrhea causes most patients to face the dilemma of no medicine or medicine. In August 2015, the State Council issued [44] Order 44 to formally review and review the innovative drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases, rare diseases, and other diseases. In November, the CFDA issued the “Announcement on Certain Policies on Drug Registration Review, Approval, and Approval”, which in turn queued the application for the above-mentioned categories of drugs and accelerated the review and approval. Evaluate Pharma's 2015 orphan drug market report estimates that by 2020, global sales of orphan drugs will reach US$ 178 billion, and domestic pharmaceutical companies will grasp the new growth point of the market to test their brainpower under the background of strong policy support.

The ninth major event, heart failure and other cardiovascular areas have re-emerged. After years of sustained high-grade fevers such as anti-cancer drugs and autoimmune diseases, we have ushered in an upsurge of new drug research and development in the traditional cardiovascular field. In July, Novartis’s high-profile chronic heart failure drug Entresto received FDA approval six weeks in advance, marking a major breakthrough in heart failure treatment in the past 25 years. The industry predicts that its annual sales peak will exceed US$6 billion. In the era of Lipitor, the development of PCSK9 inhibitors is in full swing and competition is fierce. Alirocumab (Praluent), developed by Sanofi in cooperation with Regeneron, used Evolocumab (Repatha), an adjunct to the company’s Amgen company, to approve the date of approval, and spent US$67.5 million to purchase premium review vouchers. The performance of giants undoubtedly shows that They put great emphasis on the size of the forecast market for experts that will reach as much as $10 billion. In addition, news of major pharmaceutical giants in drug development competition such as PD-1 inhibitors is also quite eye-catching.

Of course, this year is also a year for the approval of generic drugs for heavy biological drugs. Sandoz's Zarxio, which imprints Amgen Filgrassin, has been approved in the United States. Merck and South Korea's Samsung have cooperated to imitate Bioepis, an imitation of Johnson & Johnson. Renke's Renflexis was approved in South Korea and so on, marking the beginning of the heavy civilian drug era.

In the tenth event, domestic children's medicines are valued in research and development bidding. Every medical representative dreams of having an exclusive children's drug in his hands. Of course, this is just a joke. However, there is no doubt that the status quo of the domestic drug market, adult drugs will bring a large number of listed on the vast majority of drug profits squeezing, everyone in order to reduce costs led to all kinds of strange tricks frequently. In stark contrast to adult drugs, the problem of pediatric lack of medical care is very serious. Due to the fact that children's drug production is characterized by small batches, multiple batches, relatively complicated processes, high production costs, long development cycles for new drugs, and low profitability, there are few domestic companies that exclusively produce children's drugs.

In order to change this situation, related policies to support children's medicine have come one after another in recent years. From the “Encourage R&D of rare medicines and suitable dosage forms for children” proposed in the 12th Five-Year Plan period, this year’s policies from research and development to bidding have been fully supported. With the two-child policy fully liberalizing the impact of implementation, the prospect of children's medicine has exposed the dawn.

Regardless of whether you like it or not, 2015 will soon become history. This year, the international pharmaceutical market is becoming unpredictable, and domestic public hospital reforms, bidding, re-registration and other policies are sweeping the entire pharmaceutical market with the momentum of thunder and impacting the market. This is rare in previous years. This may mark the official opening of the pharmaceutical market and marks the beginning of a major year for change.