Deep | after CFDA joined ICH, how can Vic mode develop its localization path in China?

Source: shell society, June 26, 2017, editor's note: Vic mode, namely VC + IP + cro, Chinese meaning "venture capital + intellectual property + R & D outsourcing service" new drug R & D mode, was first born in the United States On June 19, CFDA officially became a member of the International Conference for the technical coordination of human drug registration (ICH) China's drug regulatory system is integrated into the regulatory system recognized by the international community, and is in line with international standards and international standards As an imported product, VIC Model will also benefit from this In the wave of internationalization of policy environment, it is gradually widely recognized by the government and capital The process of new drug research and development is expensive, time-consuming and high-risk It has been estimated that in China, a new drug costs billions of yuan on average from project establishment to market, which takes 10-13 years Major pharmaceutical companies are looking for new business models to reduce the cost and cycle of drug research and development In the 1980s, CrO (contract research organization, entrusted research institution) company rose in the United States, providing professional outsourcing services for drug development enterprises, such as drug discovery, preclinical research, clinical phase I-III research, pharmacogenomics, informatics, clinical documents, policy and regulation consultation, etc The VIC Model came into being, and innovative drug companies developed rapidly with the help of capital and cro companies On June 21, Aurora Borealis venture capital held the forum "development and investment opportunities of lighting2017 innovative drugs" in Shanghai When China officially joined the ICH, the application of VIC mode in China became a hot topic on the day of the conference Shell society, as a media support, organized the core views of the guests here for the reference of the industry Wall Dong, partner of Tonghe Yucheng: it's a new trend in China that cro can't save Vic like climbing guide, but it has been practiced in the world for a long time This has something to do with the development of various elements in the field of innovative drugs, such as capital, talents and technology The infrastructure supporting innovation is also constantly improving, resulting in enterprises like Zhaoyan, which provide end-to-end technical services Scientists can complete the whole process of new drugs from research and development to production without building their own laboratories and factories Now, more and more funds are pouring into the field of pharmaceutical investment, resulting in the result that although the time is still not compressed, the track will become very crowded For example, it's like walking on a small road, which turns into Yan'an viaduct - all blocked up This means that at a certain point in time, if an investment institution or pharmaceutical enterprise cannot catch up, it will fall into the second or third echelon Cro has a lot of customers and experiences In practice, the professional ability is constantly refined, which can ensure that the scientists with patents can avoid detours and maximize the probability of success Many new drug R & D talents have been out of large companies for quite a long time, but the contact circle is relatively narrow, many of them are only at the research level, and there are not many contacts at the clinical stage, so the founders and teams with entrepreneurial backgrounds are likely to take many detours In this case, cooperation with quality cros is equivalent to buying an insurance, which is one year higher in cost Point, but it's worth it Especially for companies that need financing to support drug research and development, the data from branded cros makes investors feel different Sometimes, new drugs are like climbing a mountain - they are risky and have a low probability of success In this process, almost all links and budgets can be compressed, but the money of the guide who takes you to mountaineering s cannot be saved I think cro is the role Ma Zhenkun, founder and CEO of Danuo Pharmaceutical (Suzhou) Co., Ltd.: Vic mode is the most effective mode of new drug research and development Our company is the practitioner of VIC mode, which is adopted Vic mode is the most effective mode of new drug research and development, with many advantages The project party can quickly use the experience of cro platform to carry out the project, with a high capital utilization rate, and can put all the investment on the project products, not the real estate A big problem is that in many cases, the Chinese government does not support the VIC Model financially In particular, some local governments will encourage enterprises to build production and give them low-cost land policies Vic model can not be used We also have many problems in project support At that time, one of our projects had passed the defense, but when the government came to the scene to check, it felt that there were too few people in our company, so we cut the funds of our project in half Pan wubin, co-founder and President of Conrad biomedical: cro is a necessary link in the industrial chain We are also a company that practices Vic mode When I came back in 2000 to make innovative drugs, I couldn't find a qualified cro company I think it's still necessary for China to be a cro This vacancy needs to be filled in the industrial chain So in 2006, I was committed to the upstream research and development of new tumor drugs This company was listed in Taiwan last year The VIC Model is not new at all in foreign countries Many people in the investment community have noticed a phenomenon that even the large international pharmaceutical companies have not developed so many products in recent years Many of them keep their double-digit growth by purchasing products from other companies It is needless to say that Vic model is feasible and superior But sometimes the government doesn't understand or even some people in the investment community don't understand or appreciate such a model In fact, I personally believe that all roads lead to Rome, and there are also successful cases for the big companies that they have built from the beginning to the end However, the advantages of our asset light model are quite large, including several key links First, in fact, VIC Model is not without difficulties, in fact, there are many risks The founders and executives of the companies that choose Vic mode must be very clear about the key links of the whole pharmaceutical industry, what kind of resources are needed, and how to manage these risks in the use of cro resources will be relatively clear Secondly, making medicine is a marathon race, which should be realized with technology and ability, including pharmacology, toxicology, etc each production link is different, and each link has different risks But this asset light mode, once you are very familiar with the risks of each link, and have the corresponding risk reduction management system, IP is the best, even if not this mode can work The number of people is not really a decisive factor Last year, a company with one person sold several hundred million yuan in the United States, but this person has done research and development, sales, business, M & A, and he is very clear about all aspects There is also a good example of Wuxi apptec, which once helped a virtual company with 2000 people sell hundreds of millions Sheng Zelin, founder and CEO of Suzhou Zejing biomedical Co., Ltd.: almost every new drug start-up company of the new generation entrusted cro company with multiple risks in phase III clinical practice is a VIC Model The founders started with idea, and the funds are either from angel fund or from venture capital New drug start-up companies must look for cros in preclinical experiments and clinical experiments, because in our country, it's impossible to do toxicology experiments without cros, and it's impossible to build teams without cros in clinical experiments If a new drug is entrusted to cro when it is in phase III clinical practice, the risk is huge Because the previous investment has reached a hundred million yuan, cro will be relied on when it comes to phase III clinical treatment The company's own team can't keep up with it Even if the drug has a 90% success rate, it may soon drop to 50% Xu Jiangping, CEO of Lansheng Pharmaceutical Co., Ltd.: CFDA standards are in line with the international standards The government will more recognize VIC Model as an early entrepreneur Sometimes it is necessary to pay attention to doing Vic There are still many pitfalls in all aspects of new drugs At present, many cro companies are at different levels and have mixed advantages and disadvantages If entrepreneurs are not screened, they are likely to fall into the pit Especially scientists returning from overseas are not very clear about the local situation, which may occur As entrepreneurs, they need to have a deep understanding of the industry and find a better organization cooperation in order to ensure that the application materials are certified by CDE, CFDA and even overseas In the future, the CFDA standard will be in line with the international standards, and the government's commitment to this aspect will be higher and higher Yao Dalin, chief scientist of Zhaoyan new drug research center: double reporting or first reporting to the United States is a good way to VIC Model, which has undoubtedly proved to be very successful, but it does not mean that everyone should adopt this model This model is very common and brilliant in the United States, but it can not be used to divide who is suitable and who is not Don't just focus on the Chinese market Now many companies are double reports from abroad and China Frankly speaking, they are definitely a plus In the past, China's approval was slow Startups went to the United States first, got the FDA's results in 30 days, and then returned to CFDA In a very long period of time from now on, it is a good way to double report or report to the United States first Song Gaoguang, an analyst of northern lights venture capital: Vic mode, which can work in assembly line in pharmaceutical industry, is one of the most fashionable ways of pharmaceutical innovation This model should be said to depend on the maturity of Chinese pharmaceutical cro in all aspects We all know that pharmaceutical research and development is a long process, and there are many segmentation links Some segmentation links can do assembly line work like other industries, which can save the time of drug research and development, improve the quality of drug development, and minimize the investment in pharmaceutical research and development At present, the domestic capital market still invests a lot in the direction of health care The rapid increase of these capitals provides new development opportunities for new drug research and development China's current stage also gives Vic a very large development space At least two of the companies we invest in belong to the VIC Model This mode also creates a lot of investment opportunities for our VC So we also believe that we can promote the development of Chinese medicine through this multi-faceted model.