Hengrui R & D is short of money and people?! On the difficulty of China's innovative drugs to pass the border from the perspective of "one brother of R & D"

With the continuous reform of the review and approval system of innovative drugs, especially the recent three drafts issued by CFDA, the opening of clinical trial base and 60 day period of clinical application and other huge changes, innovative drug research and development has been raised to an unprecedented height, and now it has become the hottest topic in the pharmaceutical industry When it comes to innovative drugs, Hengrui pharmaceutical is an inevitable enterprise Recently, Cao Guoqing, deputy general manager of Hengrui pharmaceutical, attended healthcare china2017 He described the progress and breakthrough of innovative drug research and development of Hengrui pharmaceutical in recent years, and also proposed many challenges of innovative drug research and development In his opinion, lack of money, clinical ability and leading talents are still the challenges for domestic enterprises to do innovative drug research and development Hengrui is one of the earliest innovative pharmaceutical companies in China In 2002, Hengrui established an early R & D base in Shanghai, which became the breeding ground for the development of new drugs in its core treatment field, including small molecules and biological drugs In the next ten years, Hengrui established R & D centers in Lianyungang, Shanghai, Chengdu and the United States, forming a complete R & D system with division of labor and cooperation With the rapid development of the global biopharmaceutical field, Hengrui also started systematic investment and planning in the research and development of antibody macromolecular drugs in 2012, and now has achieved phased results On the one hand, independent R & D is carried out, and on the other hand, various cooperation is carried out to implement the two major strategies of Hengrui innovation and internationalization In 2015, Hengrui not only reached a cooperative development agreement with the US biopharmaceutical rookie Incyte company for the project of PD-1 monoclonal antibody with independent intellectual property rights at a price of $795 million, but also introduced antiemetic drugs from the US Tessaro company This is not only one of the ways of benchmarking international mainstream R & D innovation, but also the embodiment of Hengrui's independent R & D achievements recognized by international mainstream enterprises It can be seen that even the domestic R & D and innovation leader, Hengrui pharmaceutical is still open to challenges Is there a lack of policy? Just a day ago, the official website of CFDA drug review center announced the publication of the 17th batch of drug registration applications to be included in the priority review process The reason for entering the priority review is that "compared with the existing treatment means, it has obvious treatment advantages" Among them, the heavyweight product of Hengrui medicine, thiopefigeristine injection (19K), is also included Obviously, as a great progress in drug review and approval, priority review channel is a great encouragement for innovative drugs to enter the market quickly It is worth noting that Hengrui's 19K was withdrawn temporarily in the process of clinical data self-examination and verification earlier Some analysis points out that 19K obtained clinical approval documents in early 2010, and started clinical earlier Some details are still different from the latest CFDA standards, so it is temporarily withdrawn Now it is clear that Hengrui has completed the sorting and improvement of data and materials, re declared for listing, and obtained the priority review But it has to be said that even the major special varieties of Hengrui have been withdrawn in the self-examination and verification of clinical data, which also sounded the alarm of improving the clinical trial capacity in China "At present, there are very few phase I clinical trial bases in China, and the level is not enough The operation is not standardized There are many patients in China, but so far, the clinical trial data in China are not accepted by FDA and EU." Cao Guoqing said Cao Guoqing pointed out that with the return of many overseas returnees and the improvement of research and development level of research institutes in Colleges and universities, the early research and development ability of new drugs in China has been improved, and the concept has also been advanced However, the new drug project has been in clinical practice for a long time, and the clinical trial ability has not been significantly improved, which has become a major factor limiting the research and development of pharmaceutical enterprises in China Fortunately, the publication of the three drafts, especially the change of the certification system of the clinical trial base to the filing system, also set a 60 day period for clinical application, which is undoubtedly a major breakthrough in solving the problem of clinical trial resources and accelerating the approval of innovative drugs Cao Guoqing also said: "the opening of CFDA clinical trial base and the policy of accelerating the application and review of new drugs will have a considerable impact on the transformation of Chinese private enterprises and the introduction of innovative drugs by foreign companies in China." In the past few years, the industry has criticized the review and approval a lot, but with the continuous reform of the review and approval system and the continuous improvement of laws and regulations in the past two years, many shackles have been opened at the policy level In particular, the three drafts released recently are regarded as a great progress in benchmarking international Many directors of domestic and foreign pharmaceutical companies have discussed that the current domestic drug review and reform policy has brought great opportunities for innovative drug research and development The chairman of a pharmaceutical company said: "such reform is rare in a century." Further reforms in the future can also be expected Recently, when he Ruyi, chief scientist of CFDA drug review center, attended healthcare china2017, he also proposed to establish a unique channel for new drug research and development, as well as explore conditional approval for listing, while implementing the priority review Lack of money? In recent years, with the gradual improvement of domestic innovation ecological environment, a large number of capital has been invested in this high-risk field, and the high financing amount of many innovative drug enterprises is a good embodiment However, when it comes to innovative drug research and development of enterprises, "in the past two years, a lot of capital has poured into the field of new drug research and development, but new drug research and development is very expensive, burning a lot of money, and lack of funds is still a disadvantage of Chinese Pharmaceutical enterprises." Cao Guoqing said As a domestic A-share listed company, Hengrui pharmaceutical has a market value of 100 billion yuan, and its annual sales revenue has already exceeded 10 billion yuan Why does Hengrui feel short of money? From the perspective of R & D investment of Hengrui pharmaceutical, the proportion of R & D investment in total revenue has been maintained at about 10% for many years, both in proportion and in quantity, it is a leader in China In 2016, Hengrui invested 1.184 billion yuan in R & D, accounting for 10.6% of the total revenue No matter the amount or proportion, there are few pharmaceutical companies in China that can match Hengrui's R & D investment However, no matter how excellent or brilliant the performance in China is, it is far from enough for Hengrui, who wants to become a global leader in medicine Obviously, Hengrui needs more capital to support its R & D innovation and internationalization goals "The current innovation opportunities are very good China's innovation soil is getting better and better If we have enough capital, we have the ability to extend innovation forward, and we are fully capable of making some breakthroughs in this regard." Cao said Indeed, on the whole, there is still a gap between domestic R & D investment and European and American enterprises According to McKinsey, in terms of innovation investment, China invested 53 billion yuan in biomedical research and development in 2015, with a growth rate of 43% in the past two years, the fastest in the world But there is still a gap compared with the United States, which is more than 800 billion yuan in R & D output In addition, how to enter the market more quickly after the innovative drugs go on the market, and how to get through the barriers in the access path such as bidding and medical insurance are also crucial It also needs further improvement at the policy level, so that a large number of R & D investment of pharmaceutical enterprises can obtain corresponding returns According to McKinsey's data, sales in the United States and Japan far exceeded those in China in terms of sales in the five years prior to the launch of new drugs On average, Japan sold six times more new drugs in the fifth year than China This gap is closely related to payment and procurement In 2017, the new medical insurance catalog was released, and the basic principle of dynamic adjustment was determined, which is also a great inspiration for the research and development of innovative drugs At present, the industry is looking forward to the introduction of dynamic adjustment rules and medical insurance payment standards There is no doubt that talents are the most important factor in the development of new drugs At present, Hengrui has more than 1300 R & D personnel, of which about 200 are engaged in preliminary R & D in Shanghai R & D center, and about 100 are engaged in monomer macromolecular research Cao Guoqing said that talents, especially leading talents, are very important for R & D and innovation of enterprises It can be said that "a thousand troops are easy to get, but a general is hard to get." "If the leaders take the wrong direction, they will fail in three or five years The money spent is not the biggest loss The biggest loss is time and opportunity If you find a very good talent, the boss of the enterprise will not have to worry, which is the essence of the pharmaceutical industry " Cao Guoqing said at the meeting earlier "Domestic high-level scientific research talents are gathering rapidly, but the industry still lacks experienced leading talents." This point of view is also clearly put forward in the construction of sustainable Chinese pharmaceutical innovation ecosystem, which is jointly promoted and completed by four pharmaceutical industry associations in the past two years, i.e China Pharmaceutical Enterprise Management Association, China Chemical Pharmaceutical Industry Association, China Chamber of Commerce for the import and export of pharmaceutical and health care products and pharmaceutical research and development industry committee of China Association of foreign funded enterprises The report points out that China has made remarkable achievements in training and introducing high-end people However, although there are some talents who can lead the breakthrough innovation in the academic circle, the number has not yet formed a scale The domestic innovative drug research and development has a short history, and the industry is still lack of leading talents with successful drug research and development records On March 31, based on the local listed pharmaceutical enterprises, e-drug managers combed the R & D leaders of the leading domestic listed pharmaceutical enterprises, described the group as a group, and launched online voting For details, please refer to [strength list] the strength competition of local pharmaceutical companies' R & D talents Who is the most powerful leader in your mind? In a week's voting time, 46259 industry people participated in the voting, and the voting results were announced as follows: sun he, vice president of tisley and CEO of science and technology innovation business group, won the championship with the highest number of votes of 11728, accounting for 25% of the total number of votes, which shows the high morale of people; Zhang Lianshan, President of global R & D of Hengrui pharmaceutical, as the leader of R & D of Hengrui pharmaceutical, a local R & D brother, achieved the second place in the voice of "dahhengrui" and "deserved", with 6893 votes, accounting for 14% of the votes Wang Jingyi, President and chief scientific officer of Kelun Pharmaceutical Pharmaceutical Research Institute, has been recognized by the industry both in Qilu pharmaceutical, the former employer, and now leads the research team of Kelun to overtake in a detour, with a high popularity, ranking third with 6743 votes Please refer to the screenshot for the specific voting: at the recent "2017 pharmaceutical health industry and finance innovation and Development Summit", many economists and pharmaceutical industry investors also put forward their judgment on the current Chinese pharmaceutical industry: "China has become a world-class pharmaceutical consumer market, but there are no world-class pharmaceutical products and pharmaceutical companies yet" At the key point of China's transformation from a pharmaceutical power to a pharmaceutical power, the R & D leaders of enterprises also play an extremely important role In the last article, we mentioned that real R & D leaders should not only have the ability to build R & D system and R & D team, but also have the overall ability to judge the development strategy of the enterprise and the dynamic trend of the industry It is not enough for Chinese enterprises to be based on the world and become the world's leading pharmaceutical enterprises.