New drug research and development will occupy an important position in the development of Chinese pharmaceutical companies September 02, 2015 Source: Bio Valley The drug and drug evaluation system ushered in the first major adjustment in the past five years. On August 18, the State Council issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval". The "Opinions" clearly pointed out that the definition of new drugs is from the current "Pharmaceuticals that have not been marketed in China" are adjusted to "drugs that are not marketed in China or overseas". At the same time, researchers in research and development institutions are allowed to hold new drug marketing licenses, optimize the approval process for innovative drugs, and allow unlisted new drugs overseas. After approval, clinical trials were carried out in China. In this regard, the industry has gradually formed such a consensus that new drug research and development will occupy an increasingly important position in the development of Chinese pharmaceutical companies. According to public data, the R&D investment of the top ten pharmaceutical companies in China is only 1% of sales, which is about 300 million US dollars. In 2013, the R&D investment of the top ten pharmaceutical companies in the world accounted for 17.8% of sales, which was US$60.39 billion. In the 2014 Global Pharmaceutical R&D Expenditure Rankings on the GEN website, Roche’s R&D investment ranks as high as $10 billion. Large pharmaceutical companies can maintain such high input costs with their large volume and complete industrial chain. For Chinese pharmaceutical companies with small and medium-sized enterprises as the main force, they independently undertake pharmacokinetics and drug safety evaluation. In the case of costly testing, companies must pay the price of reduced R&D efficiency. So in today's innovation-led policy environment, how can small and medium-sized pharmaceutical companies develop low-cost, high-efficiency new drugs? On August 26th, the strategic cooperation signed by WuXi PharmaTech and Li's Pharmaceuticals Co., Ltd. gave the answer: on the basis of maintaining certain independent research and development capabilities, it is the small and medium-sized pharmaceutical enterprises to improve research and development efficiency and focus on maintaining different forms of cooperation. A better choice for innovation. According to Dr. Li Xiaolu, Executive Director and CEO of Lee's Pharmaceuticals, Li's Pharmaceuticals is currently researching more than 40 varieties, including more than 10 new drugs in the country. “The company invests 10% of its revenue every year for R&D, but after all, it has limited resources,†Dr. Li Xiaoyan said frankly. “Working with a platform-based company like WuXi PharmaTech can achieve twice the result with half the effort.†In fact, sharing the risks and benefits of the project in a strategic cooperation mode, so that drugs can be listed faster with less money, and it is not uncommon in foreign countries, such as AstraZeneca and Quintiles, Astellas and INCResearch, Sanofi. And Covings and so on. In the future, cooperation between pharmaceutical companies will become more and more frequent, especially for enterprises with strong desire in research and development. Cooperation may even bring new ideas and breakthroughs to enterprise development. At present, most domestic pharmaceutical companies still belong to the state of "medicine" behind closed doors, and there are only a handful of cooperation between local enterprises in the field of research and development. As a CRO company that has accumulated rich cooperation experience with multinational pharmaceutical companies such as AstraZeneca, WuXi PharmaTech has opened the road of local R&D cooperation. Recently, it has reached strategic agreements with Yuheng Pharmaceutical and Zhongsheng Pharmaceutical to jointly develop. Chemical drugs, biological drugs, etc. The in-depth cooperation between WuXi PharmaTech and Li's Pharmaceuticals runs through the early stages of drug discovery, new drug applications for research and new drug listings, and even some SMOs. Dr. Liu Busan, Chief Operating Officer of WuXi PharmaTech, said that he will further cooperate with innovative companies in the future, especially for small and medium-sized enterprises to provide one-stop new drug research and development services. Liu Kejun and Li Xiaoyu have greatly appreciated the series of policies adopted by the national government to encourage the development of new drugs. This has created a policy environment for the research and development of new drugs in China. At the same time, it has put forward higher requirements for Chinese enterprises to improve their innovation ability and drug quality. New drug research projects with clinical value will continue to emerge. It is foreseeable that innovation will soon become the main theme of the Chinese pharmaceutical industry. "Chinese medicine has ushered in the spring. More than 20 years ago, the FDA increased its application fees and solved the backlog problem, and its innovation ability has been greatly improved." Dr. Li Xiaoyu said. Some insiders believe that large pharmaceutical companies may outsource drug research and development registration, clinical declaration and other projects to third-party organizations for the purpose of avoiding interests and diversifying R&D risks. Small and medium-sized pharmaceutical companies will explore different aspects from the perspective of improving R&D efficiency. Form of cooperation. Behind this subversive reform, a large number of industry opportunities are gaining momentum, and CRO companies are undoubtedly ushered in a positive. However, in Liu Chuanjun’s view, “the policy issued by CFDA has a milestone significance and truly encourages innovation. It is a decisive step for China to go international. The whole Chinese pharmaceutical industry will move towards a new era of healthy development. This is The biggest benefit." The CFDA issued the "Notice of the State Food and Drug Administration on the Self-examination of Drug Clinical Trial Data (No. 169 of 2015)", which marked the end of the clinical self-examination of the wind and fire. I believe that many companies involved have been loose. Tone, the first candid is over, but the author believes that the second hurdle is the phoenix nirvana. How have you passed? We look for some experience from history. The first part of the 169 announcement is as follows: "IV. The State Food and Drug Administration will conduct clinical trial data verification on the completion of drug registration applications completed by self-inspection materials. The verification of fraudulent problems and timely investigations will not be approved, and the results of the investigation will be disclosed to the public. †"V. Before the State Food and Drug Administration is inspected, the applicant may still apply for withdrawal on its own initiative. The State Food and Drug Administration shall publish the list of applicants and varieties and shall not pursue its responsibility." In a nutshell, the two meanings: we have to check one by one; before the company is found, the company can withdraw. In fact, there is a place in this place that is very interesting. It is the time of withdrawal. There is a slight conflict with the previous announcement. The author thinks that this change of mind should be understood as such: the reason why the more than 1000 varieties are to be self-examined, the If there is a certain problem, only the 20% withdrawal rate is obviously not up to the psychological expectations of the General Administration. Well, there must be a company with a lucky feeling mixed in it. The General Administration announced that we have to check one by one and leave a hole. If you feel unsafe, you can continue to withdraw it. How to check in the short term: Let us first try to analyze the matter of centralized rectification, and focus on rectifying a certain matter to achieve effective results. In fact, it is not only a state but also an individual’s preference for action. I believe that everyone has faced it for a long time. The house was cleaned up, and then the cleaning was carried out. Then, there was no more, and it would not be cleaned up for a long time, so I waited for the next time. The same is true of the country. The four legal crackdowns in the history of New China have their own different historical backgrounds, but the mentality is such a state of mind, but the law, drug safety is much more complicated than cleaning up the house. It can be said that the law enforcement force and the regulatory level If there is no change, if we hope to strengthen the legal system in the short term and strengthen clinical safety supervision, it will certainly be strengthened from another dimension, that is, strict enforcement and strict enforcement, and this is also the case for this clinical audit. The existence of punishment is to regulate behavior, not just for punishment. Therefore, the scope and punishment of the law must be different at different times. It is not necessarily appropriate at any time. Therefore, we can draw similar short-term The biggest positive effect of intensified punishment is shock. However, the difference in this audit is that, as Director Wu Hao said, this clinical audit is not a sport. I understand this sentence as a supplementary ticket for the enforcement of the pharmaceutical regulatory system. This is because the overall level of the pharmaceutical industry in China has reached a certain level. The previous penalties have been greatly discounted in the implementation process, so the scope and punishment of the law. The intensity will be based on this and will continue to strengthen, so the flawed corporate living space will continue to be squeezed. However, for pharmaceutical companies, the experience of severe cracking still applies, that is, the CFDA will certainly grasp the typical and severe punishment in the subsequent inspections. Therefore, the next important announcement may be to announce the first batch of enterprises that have been found. The author should remind that enterprises that have received clinical audits or have major hidden dangers should be cautious and cautious. Crap. How to prevent in the long term: Centralized remediation is like a sprint in long-distance running. It is an exhausting experience for both the regulatory authorities and the regulated departments. Therefore, many FDA precautions are expected to be the focus of the CFDA's next management. Example 1, blacklist system In fact, CFDA introduced a blacklist system in 2012. Some provinces and cities also have their own blacklist system. However, in terms of hatchback comparison, we will find that the FDA's blacklist system is much more penalized. The FDA's Generic Drugs Implementation Act provides According to different plots, the companies and individuals involved will be blacklisted. Even if the ban is lifted, the blacklist will not be removed, which is equivalent to permanent occupational taint, and the prohibition clause of the Generic Drugs Implementation Act is not only for generic drugs. In the manufacturing industry, any drug application, including innovative drugs and biological products, as long as it is an approved product under the FDA's jurisdiction, the applicant must submit a signed statement stating that no prohibited persons are involved in the declared drug. Everything is active. If a pharmaceutical company hires a banned person in the form of a company consultant or contractor, the fine can be as much as $1 million. Prohibited people who work illegally in the pharmaceutical industry are also fined up to $250,000, so once they are blacklisted, their careers are over. At present, China's blacklist system is basically very benevolent, but with the establishment and improvement of the national credit information system, the power of the blacklist system will be strengthened. Example 2, clinical third party audit At present, about 25% of the clinical trial data faced by the FDA come from abroad, so it faces a very complicated audit situation, so the FDA encourages and authorizes third-party audit institutions to participate in clinical audits. At the moment, the Chinese government encourages the purchase of third-party services. Third-party audits can greatly share the energy of the CFDA, and it will certainly be a direction of reform. For pharmaceutical companies, when conducting international multi-centers, please check with third parties, which will greatly enhance the credibility of the data, and also enhance the FDA approval rate, and also better win the CFDA. For the enterprise, the development of an industry has a process from grasshopper to formality. The grasshopper is to develop rapidly at low cost, but the formality is to connect with the world, thus completing the industrial upgrading. There is no stage which is wrong. If the two companies are indispensable, so if the pharmaceutical companies want better development, don't hope that they will not be audited, not arrested, and don't hope that this audit will end soon and improve their ability. It is the right way. This increase will inevitably bring about an increase in costs. However, Director Wu Hao has brought confidence to everyone. He clearly pointed out that "the price is low and there is no good medicine." It is the most important thing to do medicine well, not a cheap medicine. For the supervision system, prevention is the mainstay, and prevention and treatment are the basic principles for treating diseases and saving people, and also a principle for treating the industry's ills. After more than ten years of development, the general drug control model has become more and more strict, and the competition among manufacturers has become more and more fierce, which has made people at all levels in the field of general drug control and sales feel the pressure of tasks. I don’t think it’s too "playing", and I even have the feeling of "Jiang Lang is doing it." Then, under the new situation, where is the guarantee for the completion of the task of general drug control sales? We all know that the key to the success of general drug control sales is to control channels, control prices and control terminals. For the control channel and the control price, they are only the guarantee for the development of the control model, and for the terminal, it is the necessary condition for us to greatly increase sales and complete the task. The so-called control terminal is that we can choose the terminal to operate independently, through the distribution of goods, display, staff training, event promotion and other means to complete the sale of products, and other terminals not included in the selection, will not cooperate. For the selected terminals, the burden of our task is naturally on them! But most of the time, we are unable to complete the tasks set by the provincial office. We will certainly blame these terminals for not giving force, but it is not the same reason that we need to reflect on the reasons why the terminal is not strong and how can we give the terminal power? As everyone knows, when the IOC chooses sponsors, there is a “TOP planâ€. The “TOP Plan†is also called the top sponsor, also known as the “Olympic Partner Programâ€. It is the International Olympic Committee to ensure the Olympic Games are adequate and A stable financial source, a market development plan launched in 1985, selects the most famous large companies in various industries from the world as the official sponsor of the International Olympic Committee. It provides financial support to the entire Olympic movement and is currently the most successful development of the international sports market. The TOP program is an operational cycle every four years. Companies joining the program will receive global rights to use Olympic intellectual property, marketing and other related rights and related returns, and more importantly, TOP partners have exclusive rights to products, technologies and services worldwide. . This type of exclusive right is guaranteed in countries and regions by the International Olympic Committee and the national (regional) Olympic Committee and the Olympic Organizing Committee. Then, for the general drug control sales, can you also learn from this mode of operation and implement our TOP plan? First, optimize the number of terminals and make the cooperative terminal a "super terminal" We have all watched the "Super Police" series of movies starring Jackie Chan, and I am amazed at the protagonist's extraordinary ability and brave and tenacious spirit. If every policeman can become a super-police, then the case of He Chong is not detected, criminal Are the molecules not brought to justice? Similarly, for the terminal, if each cooperative terminal can be built into a "super terminal", what else can we not complete? So, what conditions do HyperTerminals need? 1. Must have a broad consumer base and greater influence. The super terminal must be excellent and must be the terminal with early establishment, good reputation, high professional level and covering medical insurance in the region. Only by cooperating with such terminal, we can achieve the goal of seizing the strategic commanding heights and strengthening the alliance. 2. There must be a common philosophy of working side by side. The cooperation between the two parties must be based on mutual benefit, mutual recognition and respect. We believe in the strength of the terminal and the terminal recognizes our development plan so that both parties can cooperate and achieve a win-win situation. And it must not be that one side "sharp and pick a head hot", if that is the case, the prospect of cooperation will not be optimistic. 3. A cooperation agreement must be signed to ensure that all work is carried out. Nowadays, the more popular phrase is called "contractual spirit". The two sides must fully communicate and coordinate before the cooperation, and clarify the rights and responsibilities of both parties. After signing the cooperation agreement, they must abide by each other and let the work be carried out smoothly. The implementation of the mission, and ultimately ensure the completion of the task. Second, through the "combination boxing", let the super terminal really exert its strength. After the "super terminal" suitable for operation is selected, we will start to implement the construction plan. Through our "combination boxing", we will create a "super terminal" with four strokes. 1. Create a home atmosphere. We want to make our super-terminals become our “home†through various types of promotional materials with novel forms, rich types and bright consumers. We will achieve the same effect as the professional stores of our own enterprises and create a good sales atmosphere. To stimulate consumer purchases. 2. Train the clerk into a "family". To build a super terminal, you must get the support of the clerk. We need to effectively train the staff through the staff training session, the WeChat class, and the recommendation skills on the event site, so that the clerk can master the skills of the course recommendation and the combination of drugs, and how to improve the "customer volume" and "customer unit price" skills. Make the clerk learn more skills and develop better in the industry. Let the clerk recognize and trust us, treat us as "family" and really help us recommend products. 3, the whole product distribution and retiring other competition sales companies competing products. Since we give the Super Terminal comprehensive support and help, and promote the super terminal to increase its visibility and competitiveness, and obtain greater economic benefits, then the other party must also give us the guarantee of all products and the reelification of other competing products. This will ensure the sales of our overall product group and effectively combat competing products, and promote sales maximization. 4. Continue to carry out store promotion activities to drive pure sales. We not only carry out store promotion activities for Super Terminals on a regular basis, but also ensure that Super Terminal products are sold or not, and we can also regularly distribute promotional posters to supermarkets such as Carrefour and carry out special promotions at different times. Posters, help the super terminal to use the festival to carry out the promotion of the corresponding theme, provide the activity plan and event gifts, become the event planning and promotion consultant of the hyper terminal, and better promote the long-term cooperation between the two parties. Some people will ask, what is the significance of implementing the TOP plan? Let me give you an example. If you originally operated 20 terminals in a region, each terminal sold 1,500 yuan per year, then the task you completed was 30,000 yuan; and if you built 10 hyper terminals from it, in your specification Under the operation, the sales of each super terminal will increase to 4,000 yuan per year, then their sales will be 40,000 yuan, so that in the case of reducing the terminal, your sales will not fall! For you, you have reduced your energy by half, so that you don't have to be exhausted, and your sales expenses are also reduced, and the economic benefits will naturally be greatly improved! Although the TOP plan has reduced us a certain number of operational terminals, it seems to reduce the chances of sales, but we have since exchanged for the whole product sales and the retreat of other sales control companies, but also firmly Isn’t it so important to control the terminal in your own hands? If you still think that such an operation is too idealistic and difficult to implement, then I hope that everyone will remember the phrase "to do things with the ultimate attitude, it is difficult to do it badly", if we really are Treat your work with the ultimate attitude, and treat the operation of the TOP plan. Then, I want to welcome everyone's must be open and cheerful, and the feeling of "sharp and bright" and a new sky! Earhook Hearing Aid Earhook Hearing Aid Shenzhen Sunshine Technology Co.,Ltd , https://www.szyatwin.com