Domestic pharmaceutical companies want to be first in class. How to choose the three business models?

Authorized introduction, independent R & D and active capital investment are three business models in the field of "true innovation" The desire for first in class is growing in China Absolute innovation strength, filling in the clinical demand gap, and hundreds of millions of sales amount are the rich connotation behind the first in class label, and also the source for the whole industry to fall in love with it In the view of most experts, although this vision will be realized in the near future, at present, the weak basic research ability, the lack of high-end talents and the low capital tolerance for risk still hinder the birth of China's first new drugs The key to the success of "authorized introduction"? "While first in class sounds exciting, it's actually too risky to provide investors with a solid return In this case, we first focus on the safety of new drugs, and then pursue the best in class effectiveness Xu Yinglin, chairman and CEO of Xu Nuo pharmaceutical, said As the latest investment project of Jingxu venture capital in biopharmaceutical sector, Xu Nuo pharmaceutical, which is positioned to introduce and develop business model, has authorized the introduction of three new small molecule tumor drugs from large pharmaceutical companies in Europe and the United States, one of which will carry out critical clinical phase III trials in the second half of this year In recent years, new drug R & D start-ups have sprung up An obvious trend is that, compared with independent R & D, many enterprises choose the business model based on introduction and development Most of the founders of these enterprises have overseas working background With the support of capital, they have authorized the introduction of early R & D projects to China from multinational pharmaceutical enterprises or small and medium-sized R & D enterprises, including some projects that reap global rights and interests So, how should enterprises choose to introduce projects to build their own advantages? Many interviewees put "vision" first, including the market potential of the product, the potential patient population and other evaluation dimensions However, finding quality projects at a reasonable price is only the first step in the long march In addition to the ability to select products, the ability to take products and the ability to develop products also determine the core competitiveness of enterprises in the process of authorized introduction "It's not easy to find a good project to talk about," Xu told medical economics "The trust of both parties, the amount of negotiation, and the 'chemical reaction' between teams are all related to the success of the transaction This is a test of the business development ability of the authorized party's team, and also requires close cooperation between business personnel and technical personnel For example, the technical personnel are generally very true to the detailed data, but no product technology is perfect As the company's top leaders, they should have certain control ability " According to Xu Yinglin, European and American enterprises attach great importance to team factor in negotiation For example, they will examine whether there are members of the other team who have worked in related treatment areas? How familiar are you? They will also ask the other party to provide a very detailed business development plan, and may even put forward harsh conditions in terms of sales Therefore, familiarity with global business rules and regulations, an international perspective and experience in global market development will help win the trust of the other party in negotiation It is worth noting that if the rights and interests of Greater China are obtained only when the two sides negotiate, the global development progress of products will determine their fate in the Chinese market In other words, if the authorized project in foreign countries is terminated due to funds, partners, internal planning and other reasons, or fails to pass the approval of FDA, the domestic project is likely to be affected "In fact, if the project has passed the critical study, there is little hope for us to take global equity, but if the critical study or POC is done by ourselves, and the number of patients treated by this product is the largest in China, we should strive for global equity." According to Xue Qun, chairman and CEO of Beihai Kangcheng, there are many challenges for start-ups to develop the global market, and it's difficult to achieve one step in place, "but we can advance the project to a certain extent and then license out." Although he has acquired the rights and interests of Greater China or the global rights and interests of three potential products, Xue Qun does not simply define Beihai Kangcheng as a "start-up enterprise adopting the introduction and development of a single business model" He believes that only by bringing in and going out can an enterprise form a healthy development ecosystem "I believe that in the future, the value of our product pipeline will also be reflected through cross-border authorization or joint development." "Independent research and development" or "authorized introduction"? The reporter observed that at present, the stage of the introduction of new drug projects by domestic enterprises is mostly concentrated in clinical phase II, and the published clinical data has often come to the fore At this time, the follow-up phase III clinical development can almost double the success rate Xue Qun revealed some helplessness in the research and development of new drugs of this "taking doctrine" On the one hand, domestic scientific research institutions have not yet developed large-scale intellectual property projects with global value for enterprises to choose from in the field of life science; on the other hand, local enterprises do not have strong strength to invest in the field of research and development to build a world-class development team to carry these exploratory research "New drug research and development is a process of gradual accumulation, just as the pyramid must have a large tower as the foundation to build a spire." Xue Qun pointed out that even in western countries with rich resources such as scientific research institutions, funds, top hospitals and so on, after decades of accumulation, a new drug will go through a long time and countless failures from its initial discovery to its final listing "In contrast to China's national conditions, our foundation is still weak." This coincides with Wang Jin, general manager of CCB He believes that whether from the perspective of basic research, patent protection or business awareness, the time for Chinese enterprises to realize independent innovation and R & D is not mature enough Although domestic enterprises invest a lot of money in the research and development of class 1 new drugs every year, they are more inclined to some verified targets, and there are only a few products with truly innovative elements "With the increase of investment in innovation in the whole industry, more pioneers are cutting through difficulties in basic life science, basic medicine, especially clinical medicine Maybe we can find more and better transformational medicine in the future." "The two models of independent R & D and introduction and development are complementary." As the former founder of Biology Department of Roche Shanghai R & D center, Dr Wu Zheng transferred the clinical candidate drug ak0529 of respiratory syncytial virus (RSV) that he led the research and development from Roche, and founded the biopharmaceutical company aikebaifa, which focuses on antiviral and children's drug research and development He told reporters that at present, the company adopts the "two legged walking" mode On the one hand, it continues to promote the global multi center clinical trial of the introduction project ak0529, and on the other hand, it starts from a long-term perspective to carry out the first in class new drug research and development project "It takes a long time to prepare for the establishment of new drug R & D laboratories, recruit scientists and establish new R & D projects If a biomedical enterprise can have a mature clinical project to move forward at the beginning of its establishment and gradually establish its own R & D capability, it can make more efficient use of time " Compared with five years ago, the environment of new drug research and development in China is already different The policy dividend of Dabo, the influx of capital and a large number of overseas returnees with rich experience boost the industry's enthusiasm for innovative drug research and development The "real innovation" represented by first in class has become a topic that the industry is fond of, rather than the "pseudo innovation" represented by me too in the past It is important to have an innovative drug with independent intellectual property rights, but more importantly, it is supported by data-driven scientific research, rather than simply pursuing the hot target of "money" prospect, innovation for innovation "Innovation is that we have the ability to do what others don't have Our new drug projects are all based on the rich practical experience of the R & D team and the deep understanding of its scientific mechanism " Dr Wu said frankly "With the simultaneous development of independent R & D and imported development modes, I look forward to seeing innovative products with high gold content, which can truly solve clinical needs and be valued by investors and large pharmaceutical companies in the market." However, Wang Jin pointed out that the domestic payment system is still difficult to afford real innovative products, and the products of "imitating innovation" or "micro innovation" are also worthy of support, but speed will become the focus of competition among enterprises Active capital investment: mature or early? As we all know, new drug research and development is a bottomless hole for burning money Team building, project research and clinical trials are inseparable from the support of funds at every stage Without a large amount of funds to continue "blood transfusion", it is difficult for enterprises to develop in a long-term and sustainable way The importance of money for new drug research and development is self-evident However, at present, China's capital market still does not support drug R & D companies without any sales profit, and domestic new drug start-ups have to rely more on external financing It is reported that the investment cycle of foreign new drugs is generally more than ten years "The more innovative the field is, the more clinical problems need to be solved, and the more favored the foreign investment community Whether it is new drugs, new diagnostic methods or new treatment solutions, they are particularly able to get financial support." Wang Jin said In contrast, the investment cycle of domestic institutions is relatively short, generally "5 + 2" (i.e 5-year investment, 2-year exit), and at most "7 + 2" The short investment time determines that it is impossible for investment institutions to intervene in early projects On the other hand, the earlier the new drug project is, the higher the risk is, and the greater the possibility of failure is This is also an important reason that most domestic enterprises focus on introducing projects in the middle and late stage of clinical practice "From license to development or nrdo (no research, development only) may be a more acceptable business model for domestic investors in the near future." According to Wang Jin, 60% - 70% of new drug projects of large pharmaceutical enterprises rely on external introduction This business model has been proved to be efficient, fast and low-cost, which is also more favorable to foreign VC The reporter learned in the interview that, in fact, new drug start-ups in the United States rarely start research and development of new drugs from the source Unless they have their own unique platform technology to develop products, most enterprises still rely mainly on the mode of authorized introduction, obtain technology or product patent authorization from university scientific research institutions, and then further develop new drugs on this basis There are also a small number of enterprises through the purchase of patents of other enterprises, or with VC cooperation to buy large companies spin off products The biggest difference with the products introduced by Chinese start-ups is that the