2014 pharmaceutical industry in-depth inventory and Outlook

Source: bioprospecting 2014-12-17 2014 is about to pass For most Chinese pharmaceutical enterprises, there are still feelings of winter: the growth rate is declining, profits are declining, marketing is weak, and commercial bribery is strictly controlled Nevertheless, through a number of signs in a long year, we can hear the sound of ice breaking If we use one word to describe the theme of China's pharmaceutical industry in 2014, I think it is two words: "return", return to the market, return to order, return to hope The Third Plenary Session of the 18th CPC Central Committee, a year ago, made the market play a decisive role in resource allocation For many years, China's pharmaceutical industry has been in charge of price, bidding and access The hand of the government is sinking deeper and deeper, but as a result, it becomes more and more disorderly No one is satisfied with it, from the central government to the people Finally, we see that the shape only hand seems to start to relax In August, the director of the price department of the national development and Reform Commission was taken away, and the collapse of the price department began In just a few months, the price department has successively settled down five Hall officials Including Cao Changqing, Liu Zhenqiu, Zhou Wangjun, Guo Jianying, etc., the name is not unfamiliar to many pharmaceutical enterprises, especially the Ministry of government affairs It's the price of the medicine that ties them together It may not be appropriate to hit them with all the boards with high drug prices and expensive medical treatment However, it is generally acknowledged that the transitional intervention of the administrative hand has indeed distorted the Chinese pharmaceutical market, and the drug price is the representative of the typical chaos The fact that the government can't control the price well has been confirmed again At the end of November, the draft of "promoting drug price reform plan" issued by the national development and Reform Commission was issued to all pharmaceutical industry associations, stating that the government's maximum retail price limit or ex factory price of drugs was to be cancelled, and the actual transaction price of drugs was formed by market competition through medical insurance fee control and bidding procurement, which was to be implemented from January 1, 2015 In fact, by the end of last year, the industry had heard that the maximum retail price limit of drugs would be adjusted, but it was not expected to be launched in such a way and at such a pace, which seemed to highlight the attitude of high-level executives to promote market regulation in the pharmaceutical industry However, compared with price control, pharmaceutical companies feel more administrative improper intervention, or centralized bidding This policy, which has been criticized for many years, seems to have begun to show signs of loosening In the new bidding policies launched by various regions, many provinces began to change their low price policies, increase their quality weight, and spread the news of classified procurement In May, the catalogue of low-cost drugs was officially released, which again impacted the bidding policy However, in the course of this year, although the industry has repeatedly heard that the health and Family Planning Commission has held various meetings on reform and the trend of authenticity and falsehood, compared with the vigorous reform of price policy, the reform of bidding still has no clear direction The anxiety behind this is very intriguing It is not only medicine, but also medicine that the high-level wants to promote the marketization, although there are still various forces behind the game In April, the national development and Reform Commission, the health and Family Planning Commission and the Ministry of human resources and Social Security jointly issued policies to completely liberalize the price control of non-public medical institutions In June, the national health and Family Planning Commission issued documents for the first time to control the excessive expansion of public hospitals Some local governments are more enthusiastic about promoting private investment into the medical service market In July, Beijing issued the management measures for doctors' multi-point practice in Beijing; in November, Shenzhen issued the medical regulations of Shenzhen Special Economic Zone (Draft for comments), and planned to cancel the restrictions on doctors' first practice place The enthusiasm of the government also drives the enthusiasm of non-public capital Since last year, from financial capital to industrial capital, all kinds of funds have been competing in the battlefield of public hospital acquisition Many pharmaceutical enterprises, such as Wuhan Jianmin Pharmaceutical Co., Ltd and Kunming Pharmaceutical Co., Ltd., have made clear the direction of their investment in medical services; real estate enterprises, such as Vanke and Evergrande, have begun to prepare for the establishment of their own hospitals; Beijing United Family has opened many branches Caixin magazine takes this as its cover, entitled "the hospital is ripe" At the end of the year, the two top private hospitals, Peking University International Hospital and Tsinghua Changgeng hospital, which had been planning for many years, finally opened one after another within two weeks, which perfectly annotated the first year picture of the private hospital In an unexpected episode, Zhang Haipeng, CEO of China Resources medical, who led the company's layout in the medical service market for many years in advance, resigned in July for personal reasons Although his departure is believed to be related to the fall of Song Lin, chairman of China Resources, it also suggests to some extent that the market-oriented operation of medical services is not easy In 2014, we saw that China's pharmaceutical industry is moving slowly towards marketization It's hard to predict what will happen in the end However, looking back in March, at the executive meeting of the State Council to deepen the reform of the medical and health system, Premier Li Keqiang put forward a new concept: the linkage of medical insurance, medical treatment and medicine, which requires the improvement of medical insurance, innovation of medical treatment and standardization of medicine If we link this direction with the changes in the following years, we may have a clearer outlook for the future It is undeniable that the return to order is accompanied by the high growth and profits of the Chinese pharmaceutical industry, as well as the imperfection of many orders including marketing and production In 2014, however, some significant changes began to take place Once upon a time, officials in the system thought that it would be a gust of wind for the new leadership to seize the anti-corruption meeting, and it would be better if it passed They proved wrong and underestimated the determination of the top Such misjudgment also appears in the speculation of the pharmaceutical industry on the anti pharmaceutical commercial bribery started in the GSK incident last year Although the GSK incident has been over a year and a half, the life of medical representatives is not easy, but increasingly difficult The pharmaceutical agents sent by major hospitals to pharmaceutical enterprises can be said to be strictly guarded The hospital's self-conscious attitude of prevention has puzzled the industry, but the news gradually spread out in the middle of the year seems to have a clear answer In July, some media began to reveal that since 2013, the procuratorate has arrested 1727 hospital presidents after officially approving the case filing At this time, most people in the industry just realized that public hospitals, as public institutions, had no reason to survive in this unprecedented anti-corruption storm As a pharmaceutical enterprise, it may really need to change whether it is love or hate for the gold sales that have become potential rules for many years Similarly, production is also in order In January, 523 sterile drug manufacturers began to stop production due to their failure to pass GMP certification About 40% of the sterile drug enterprises failed to pass the new GMP certification It is obvious in the industry that this certification is not a walk through, and this is just the beginning In May, CFDA issued the letter on Soliciting Opinions on the methods of drug flight inspection, which strongly attacked the new version of flight inspection In the following half a year, more than ten GMP certificates of pharmaceutical enterprises were recovered, including the amendment of pharmaceutical industry by famous enterprises There have been concerns about whether such efforts will affect the supply of drugs, but it turns out to be alarmist For China's pharmaceutical industry, which has more than 4000 pharmaceutical companies, overcapacity is a bigger problem than good and bad The strength of the regulatory authorities for the new GMP treatment standard clearly shows the willingness to promote the survival of the fittest, merger and reorganization of the industry, which is undoubtedly beneficial to the development of the industry There are not only overcapacity, but also varieties According to some statistics, at present, there are more than 160000 approvals for Chinese pharmaceutical enterprises, of which more than 90% are sleeping approvals Since September, CFDA has been the first to release two batches of transitional duplicate drug categories This is the first time for CFDA to inspect and publicize the over listed and declared products, and formally remind enterprises to assess relevant risks In the future, such warning will also be normalized, and the regulatory authorities hope to avoid the same level of duplication of market drugs, prevent the risk of R & D investment, and promote the healthy development of the pharmaceutical industry Rectify commercial bribery, improve production standards, carry out quality flight inspection, repeat warning varieties After this series of measures, we have seen the determination of high-level officials to eliminate the backward, repetitive and irregular medical industry ecology These little improvements are bringing us back to order Back to hope in 2014, China's pharmaceutical industry has many anxious problems, which seem to flash a little hope First of all, it seems that the slow review of new drugs, which has puzzled the industry for many years, has finally attracted the attention of senior management and started to seek solutions In May, Yin Li, deputy director of CFDA, confirmed at the annual meeting of drug information association in China that government purchasing services will become an important means to improve the efficiency of drug evaluation This is the first time CFDA has made it clear that it will purchase services from a third party In November, CDE signed a cooperation framework agreement with Peking University Hospital There is speculation in the industry that this may be the beginning of high-level exploration and introduction of third-party review More signs of accelerated review are also emerging In May, CDE selected 62 generic drugs of which foreign patents are about to expire, making it clear that it will speed up the review Shortly after that, the news of CFDA's recruitment expansion began to come out In November, Li Maozhong, deputy director of CFDA registration department, said publicly that in the future, there will be reforms in the process of drug registration acceptance, review process, charging and concept We also look forward to such changes, which will benefit the public and enterprises China's new drug research and development continues to advance steadily In November, hpatinib, a new Hengrui drug, was officially approved for marketing At the same time, sidaaniline, a subtype selective histone deacetylase inhibitor with new chemical structure and global patent authorization, independently developed by Shenzhen micro core biology, is about to be approved That is to say, after exetane and conbercept, the independent research and development of new drugs in China has made great achievements Not only that, we also see a significant increase in the number and quality of the first generic products declared by Chinese pharmaceutical companies In March, the national health and Family Planning Commission again launched the application of 2015 major project of major new drug creation and technology The most obvious difference between the notice and the previous application guidance plan is that the plan points out the target research and development direction in the major special treatment field, and mainly supports me too, me better, and adjusts to support first in class This indicates that China's pharmaceutical industry has begun to move from imitation to innovation Health care reform continues to attract attention In 2014, Sanming medical reform was put in the spotlight of the public and received extensive hot discussion Represented by a series of measures such as the annual salary system of the hospital, the zero difference rate of drugs, and the unified management of the "Three Guarantees" fund, the unique "Sanming mode" has once again made a new exploration for China's medical reform Some are positive, some are skeptical, some are negative No one can say for sure now what the future will be, only time can continue to prove However, compared with the small step forward of Sanming medical reform, in this year, the pace of Internet enterprises entering the medical and health industry is magnificent In January, Alibaba invested $170 million in CITIC 21cn, and then launched the "future hospital" plan in Hangzhou in May; in June, Tencent launched the wechat full process medical platform in Guangdong; in July, baidu led the launch of the "Beijing health cloud" platform, Tencent wechat opened the intelligent hardware interface, and accessed the "wechat version" smart bracelet of four manufacturers, including ihealth; 9 Month, Tencent