Worry about the prospect and the current situation

Source: on November 18, 2014, e-medicine manager made innovative medicine in China, which has a high pace As for the question raised by e drug manager, "is China capable of developing drugs with independent innovation at this stage?" The answers given by policy makers, academics, industry and third-party observation and consultation institutions are all affirmative Wang Jingang, chairman of Hisense Bicheng, is even excited to use three "must be able" to express his confidence in the future of China's innovative drugs However, when the question extends to "whether China's independently innovated drugs can occupy a place in the international market and become a" blockbuster "class product", most people begin to have reservations Optimists believe that "there will be some products, but the process of internationalization is a little slow Only as Chinese pharmaceutical enterprises more participate in the competition in the international drug market, can there be large varieties of innovative drugs sold overseas." And the pessimist's context is: "if Chinese independent innovative drugs refer to the establishment of new targets and their mechanism of action, the screening of candidate chemicals and the completion of clinical trials are all independently completed by Chinese pharmaceutical enterprises, then further efforts are needed to achieve this goal." Chen Kaixian, academician of the Chinese Academy of Sciences and expert in the field of drug design and new drug research, summed up the three strategies of China's innovative drugs in 2012: the 1990s-2010 is the experience accumulation stage of China's innovative drug research and development, and the main task of this stage is that the framework of the independent innovation system has a prototype; 2010-2015 In 2015-2020 is the leap stage of China's innovative drug research and development At this time, China's drug research and development level and ability strive to occupy a place in the international market Now, it's the critical time for the third stage In the summer of 2013, LV Qiang changed his career path After five years of working as vice president of biomedical research and development of Wuxi pharmaceutical, he became Vice President and chief scientist of Yangzijiang Pharmaceutical Group and directly led Shanghai Haiyan Pharmaceutical Technology Co., Ltd., a subsidiary of Yangzijiang pharmaceutical "The environment for local pharmaceutical companies to start new drug research and development is basically mature." This is the main reason why he decided to choose Yangzijiang pharmaceutical, a local Chinese enterprise Lu Qiang's main task is to "make up the short board of pharmaceutical research and development, especially new drug research and development" in Yangtze River, and build a research and development system suitable for Yangtze River business model Now, through independent R & D and patent licensing, LV Qiang has screened three products for Haiyan In fact, in the past few years, there have been many returned researchers who have devoted their careers to local pharmaceutical companies Zang Jingwu, former global vice president of GSK, finally chose Xiansheng pharmaceutical as his new career start after almost a year of silence of GSK paper event, and was responsible for the "baijiahui" new drug innovation and entrepreneurship platform His goal is "to provide early investment and financing services for 80-100 entrepreneurial projects in five years, and to incubate and cultivate no less than 70 biomedical research and development innovation and entrepreneurship companies." Wang Peng, who has been engaged in the research and development of innovative drugs in Schering plough Research Institute for 18 years, accepted the invitation of Ren Wuxian, chairman of Yabao pharmaceutical industry, with an annual salary of 3 million yuan in 2013, and became the president of Beijing Research Institute There are those who leave and return Du Ying, founder of Hutchison Whampoa pharmaceutical, joined Sequoia Capital to take charge of investment in the field of health care In 2014, she brought us $30 million raised from Qiming venture capital, kaipenghuaying and other investment institutions to establish zaiding pharmaceutical For the first time, she signed a global license agreement with Sanofi for the development and commercialization of two new compounds At the same time, the R & D investment of local pharmaceutical enterprises is also increasing In 2013, Kelun pharmaceutical invested 400 million yuan in R & D, with a growth rate of nearly 100% compared with that in 2012; the R & D cost invested by TSL was 364 million yuan, an increase of 72.67% over last year Liu Dianbo, chairman of LVYE pharmaceutical, said at the 2013 annual meeting of Chinese pharmaceutical entrepreneurs that in the next 10 years, LVYE will continue to devote 10% - 20% of its annual sales to R & D It is reported that nearly 30 billion yuan has been invested in the research and development of new drugs since the country officially implemented the major new drug creation project in 2008, and this investment continues to increase To a large extent, this has encouraged the enthusiasm of Chinese pharmaceutical enterprises in R & D The investment enthusiasm of social capital is increasing year by year, and the number of various investment institutions focusing on the pharmaceutical industry has increased year by year in the past five years Although the interest tendency of capital makes it still have some natural deficiencies in the investment of innovative drugs, and more hope to choose to invest in products that have entered the late clinical stage with less risk, its lubricating role in the whole industrial chain of innovative drug research and development cannot be ignored What's more, the confidence of Chinese people is that 1.1 new drugs have been listed in succession This year, there are two most representative drugs: one is the anticancer drug sidabanide of microchip biology, and the other is apatinib of Hengrui Sidabamide is the first product of microchip biology founded by Lu Xianping in 2001, after 13 years of research and development, which is finally listed in China Different from traditional chemotherapy drugs and molecular targeted drugs, xidaban is a new theory of epigenetic regulation mechanism to achieve antitumor effect Apatinib is the first small molecule targeting drug of Hengrui It is a drug modified on the basis of vandetanib and PTK787 It is suitable for cancer patients after the failure of other treatment methods Clinical research shows that its antitumor effect is better than that of PTK787 In the past, the most representative drugs were cetinib of Beida pharmaceutical and conbercept of Kanghong pharmaceutical As the first Tinian drug developed and listed by local enterprises, ektinib dares to conduct head-to-head comparative experiments with similar products of foreign enterprises, and its market performance after listing also makes the whole industry understand that innovative drugs can earn money without medical insurance The listing of conbercept forced its international competitors to change their sales strategies to cope with the market impact Don't mistake the enthusiasm for research and development "In addition to the original new drugs, Kemena and conbercept have obtained patents through structural modification of the compounds with proven target activity, and become exclusive new drugs through clinical development, which is commonly known as me too or me better." A researcher at a pharmaceutical research institute said A generally accepted definition of innovative drug can be divided into three levels: the highest level is the first in disease in a disease field; the second level is the first in class in a treatment mechanism; the third level is the best in class in the same treatment mechanism In fact, the FDA treats me too as a new drug Take erectile dysfunction drugs as an example After Pfizer launched Viagra, Lilly and Bayer later launched similar products, such as hilly and Elida In fact, Aida and Viagra are very similar in structure They are all type 5 phosphodiesterase (PDE5) inhibitors The difference is that one is piperidine methyl, the other is piperidine ethyl, and the other is the position of nitrogen atom "It's right to make new drugs in China in this way China's R & D level needs to be improved step by step at this stage It's not realistic to step into the field of treatment or complete innovation of treatment mechanism." As a matter of fact, "even Hengrui, an enterprise that continuously pays attention to the research and development of innovative drugs and has a sound research and development system, seldom touches the active compounds with unclear targets." One industry observer said In fact, at this stage, the biggest dispute among experts in the industry over the research and development of new drugs in China is not whether to move forward in the direction of me too and me better or to do first in disease or first in class with all one's heart, but to use the research enthusiasm in the wrong place "It's very irrational to apply for research projects What's become a hot spot is swarming The phenomenon of repeated application is staged again at a higher level." This is almost the same statement of many interviewees For example, DPP-4 inhibitors, a hot diabetes drug in the market, are used Local enterprises have applied for new drugs for this target, including retagliptin, berggliptin, egletin, vogliptin, egletin, eugliptin and so on Some enterprises have also applied for the imitation of sigletin, sagletin, ligletin and tigletin No wonder some people in the industry exclaimed, "this is the rhythm to be squeezed to death!" Liu riting, vice president of Jiangsu Wanbang biochemical medicine group, analyzed that the deep reason for the emergence of "follow the trend" as a behavior mode with Chinese characteristics in the field of new drug research and development lies in the lack of excellent project research talents or teams in China "The basis of domestic project establishment is generally the new drug information, market information and Chinese patent literature of public database There is also a kind of easy project approval personnel, most of whom look at the website of CFDA in China, and find that many people make new drugs of this compound, and then follow the project approval And the literature tracked by professional project managers is original papers such as science and nature The content of research is the possibility of drug preparation of various drug targets and signal transduction pathways, as well as the results of clinical trials Huang Zhenhua, chairman of Shandong Henley Pharmaceutical Technology Co., Ltd., thinks that two points should be paid attention to when predicting the market opportunities of me too new drugs: first, there should be no more than three similar drugs on the market, and the time to market should be five years ahead of the first generic drugs Otherwise, the price advantage of generic drugs will make the competitiveness of the new me too drugs in the market collapse rapidly In addition, the original new drug has defects in clinical use or the me too new drug has obvious clinical advantages "But at present, many enterprises are actually trading the risk of market and sales for the safety of R & D That's why companies are flocking to research and development " Liu riting stressed that when cooperation and opening up become the mainstream way of new drug R & D, the domestic demand for excellent R & D talents is not only the academic background, but also the quality of various comprehensive capabilities For example: the ability to understand the market value of R & D products, to meet the business ability of international product development of enterprises, and to have extensive network ability with global R & D frontier organizations and enterprises and top talents Foreign licensing and domestic introduction have once been said by insiders that when multinational pharmaceutical companies look for new drug R & D projects in China, it means that the level of new drugs in China has been basically "in place" In 2013, Tianjin PuYing Biotechnology Co., Ltd licensed the U.S patent for the original molecular structure of its long-acting HSA fusion protein new drug to TIWA pharmaceutical, charging a one-time license fee of US $10 million, and the patent technology is only limited to the marketing of the drug in the U.S region Prior to this, furquitinib, a new selective inhibitor of vascular endothelial growth factor tyrosine kinase receptor developed by Hutchison Whampoa pharmaceutical, entered phase II clinical trial, reached a joint development agreement with Lilly, and received Lilly's