Heavy pharmaceutical review reform documents released in the injection industry and then welcome the "life and death storm"
Wang Yue
After more than four months, the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices" (hereinafter referred to as "Opinions") jointly issued by the General Office of the CPC Central Committee and the General Office of the State Council was officially released. Compared with the 1659-word opinion draft four months ago, this official version of the "Opinions" with 6,714 words and 36 specific opinions can be described as exciting. Many people in the industry have forwarded comments in the circle of friends. The medical reform cannot wait for an era of inability to wait and see. Coming soon.
"This is a programmatic document. The theme is to encourage innovation. The focus is on solving the problem of public medication, so that the public can use new medicines and use good medicines, so that doctors can have patients in the process of treating patients. More choices. The key to solving the problem of public drug use is innovation. It is necessary to get some new drugs listed as soon as possible, not only the domestic new drugs, but also the new drugs from abroad as soon as possible in China." On October 9th, this time The "Opinions" issued by Wu Hao, deputy director of the State Food and Drug Administration, said.
However, for traditional pharmaceutical companies that focus on the production of injections and APIs, the introduction of this document also means that the transformation of enterprises will face “speed of life and deathâ€.
Injection market will shrink further
In this "Opinions", Articles 11 and 25 all point to the management of injections: future oral preparations can meet clinical needs, and injection preparations are not approved for marketing; intramuscular preparations can meet clinical needs, The intravenous preparations are not approved for marketing, and in addition, efforts will be made to re-evaluate the marketed pharmaceutical injections for 5-10 years.
"In recent years, there have been many controversies about injections, especially Chinese medicine injections, and the adverse reactions have made the market talk about it." A pharmaceutical industry analyst told reporters, "In addition to the recent two Chinese medicine injection recalls, the state's injection production The attitude of tightening and raising the threshold is obvious."
In fact, affected by the hospital's control fees, various injections represented by traditional Chinese medicine injections have suffered from the suspension of the top three hospitals since last year. At the end of last year, a top three hospital in Zhejiang even announced a one-time suspension of up to 22 injections. In the 2017 edition of the National Health Insurance Catalog issued by the Ministry of Human Resources and Social Security, the use of traditional Chinese medicine injections was limited: in the total of 45 kinds of Chinese medicine injections that were short-listed for medical insurance, as many as 37 Chinese medicine injections were restricted to secondary and above medical institutions. And limited to severe cases, the limit is as high as 82.22%.
"Under normal circumstances, once you enter the medical insurance catalog, manufacturers of medical insurance will no longer have pricing power, but entering medical insurance will increase the sales of pharmaceuticals, which is actually beneficial to enterprises. For the traditional Chinese medicine injections with limited medical insurance, After not having the pricing power, the sales volume is also facing a sharp decline. It is conceivable that this is a big impact on the manufacturers of some Chinese medicine injections.†The above-mentioned insiders said that in his view, the Chinese medicine injection market will usher in this. Shuffle, up to two-thirds of the product or will exit the market.
In fact, the impact of policies on the industry has been shown in the annual reports of listed companies. Taking Hongri Pharmaceutical (300026.SZ) as an example, according to its latest 2017 interim report, during the reporting period, the company achieved operating income of 1.44 billion yuan, down 17.36% year-on-year; realized operating profit of 330 million yuan, down year-on-year. 0.4%; net profit attributable to shareholders of listed companies was 280 million yuan, a year-on-year decrease of 9.32%. Among them, the operating income of Xuebijing Injection, one of the company's main products, decreased by 64.64% compared with the same period of last year. The company's report pointed out that the main reason for the decrease in key operating indicators compared with the same period of last year was the multiple influences of industry policies.
New drug market will usher in China speed
While the traditional pharmaceutical industry is facing challenges, pharmaceutical companies that focus on R&D and new varieties have ushered in the spring. The "new first-line" pharmaceutical giants, including Hengrui Medicine and Fosun Pharma, all rose by 3%-5% in early trading. Investors were optimistic about the impact of the New Deal on these pharmaceutical companies.
"It's amazing. I feel that China's new drug review and approval standards are basically synchronized with the international market. It is indeed China's speed!" The president of a listed company commented on the full text of the "Opinions" last night.
Indeed, for most pharmaceutical companies that are investing heavily in research and development and improving pharmaceutical production standards, this document, which encourages innovation and accelerates the review of new drug trials, can be said to have given the industry a boost.
Taking clinical trial management as an example, the clinical trial was changed from an explicit license to an implied license. This means that if no doubt or denial is made within the stipulated time, the applicant can conduct clinical trials, which greatly shortens the application time.
"There are conditions for accepting data from overseas multi-center clinical trials, which was originally unusable in China. Now we are beginning to accept conditions. Foreign data that meet the requirements for drug registration in China can also be used in our review. The purpose is to Shorten the approval time. Also, encourage social forces to invest in setting up clinical trial institutions to participate in clinical trials and solve the bottleneck of insufficient clinical trial resources.†At the press conference held today, CFDA (National Food and Drug Administration) Pharmaceutical Registration Division Director Wang Lifeng said so.
In addition, including the optimization of the review and approval procedures, and the strengthening of the protection of innovative rights and interests, etc. have responded to many hot issues raised in the past industry and solutions. For the time of review delays, the "Opinions" even proposed that the patent period will be compensated.
In fact, since the introduction of the new drug review and approval reform two years ago, the “slow speed†of the newly criticized new drug approval has been greatly relieved: according to the latest disclosure by CFDA Deputy Director Sun Xianze on September 24 Data, the number of drug applications awaiting approval has been reduced from 22,000 in the peak period of 2015 to 3,755, and just a few days ago, this figure was still more than 4,000, which means that within a week, the drug review backlog It can reduce nearly 300 pieces.
Under high efficiency, we are welcoming the accelerated launch of many innovative drugs. In July of this year, Novartis's innovative medicine for heart failure, Entresto, entered China and brought world-class innovative drugs to patients. This time is less than two years from the United States, which is the average speed of new drugs in China in the past. 3.5 times. The approval of Gilead's new hepatitis C drug Sovaldi in China has completely changed the face of hepatitis C treatment and is expected to eliminate the infection.
"In the previous reforms, we have achieved some phased results, mainly to basically solve the backlog of drug registration applications. The most important burden in the past is to declare the backlog, the amount is too large, and now it has basically been solved. In the past two years, a number of new drugs and innovative medical devices have been approved for listing. The atmosphere of domestic pharmaceutical innovation has become increasingly strong, and some overseas medical researchers have returned to China to innovate more and more, and the investment in R&D has increased significantly, which has greatly stimulated drugs. The vitality of medical device innovation. This is the effect of reforms in recent years.†Wu Hao said.
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