Microchip biology: independent research and development of new anticancer drugs, creating many firsts

Recently, Lu Xianping, who used to fly all over the world, is even busier Just half an hour before Nanfang Daily's visit, he just finished filming a documentary about innovation on Mango and Korean TV Since the original anti-cancer drug xidaban (trade name: epidaza) independently developed was approved for listing, the president of Shenzhen micro core Biotechnology Co., Ltd (hereinafter referred to as "micro core biology") has become the "Darling" of the press Together with the team of scientists in the United States who returned home with him 15 years ago to start their own business, they have been repeatedly exposed in the spotlight In fact, it is inevitable Although China is the world's largest producer of pharmaceutical preparations and APIs, 98% of its products are generic As China's first original new drug licensed to the United States and other developed countries for patent use and simultaneous global development, it will undoubtedly leave a strong mark in the history of Chinese pharmaceutical innovation As the inventor of xidaban, the micro core organism also has a natural halo Now, relying on the independently constructed pharmaceutical innovation technology system, this domestic landmark enterprise that researches and develops small molecule patented innovative drugs, has established a number of original new drug product lines in the fields of tumor, diabetes, immune diseases, etc., and is about to usher in the huge return of performance explosion The development of China's original new drugs authorizes the developed countries to use the micro core organisms mentioned by Xianhe, so we can't do without the use of cisdaben At present, there are only three enterprises producing similar drugs in the world, two of which are in the United States Compared with the international new drugs for PTCL treatment, sidabamide has obvious subtype treatment advantages and long-term survival benefits The early clinical results showed that the clinical benefit rate of the patients taking cedarbendamine was nearly 50%, and the survival period was significantly prolonged Compared with similar drugs in foreign countries, the monthly treatment cost of xidaban is 280000 yuan and 140000 yuan respectively, and the monthly treatment cost of xidaban is 26000 yuan Although China is the world's largest producer of pharmaceutical preparations and APIs, 98% of the products are generic drugs, and only a few new drugs created by China and recognized by the world Especially in the field of anti-tumor drugs, almost all of the domestic drugs are imitations, and there are only innovative drugs with independent intellectual property rights "In the field of biomedicine, it is very important to have core technologies and patented inventions Because only independent research and development, access to core patented technology, China's pharmaceutical enterprises have the hope to get rid of the fate of "imitation" and simply relying on price war to win market share " Lu Xianping said As an original new drug with new chemical structure and global patent authorization, xidaban has created many firsts: the world's first oral drug for the treatment of recurrent and refractory peripheral T-cell lymphoma, the world's first approved selective histone deacetylase inhibitor What's more, sidabamide has also become the first Chinese original chemical new drug that is authorized to be used by developed countries such as the United States and developed synchronously in the world In December 2014, xidaban was approved to be listed by the State Food and Drug Administration (CFDA) As early as 2006, microchip biology successfully authorized overseas patents of xidaban under development to Huya Biosciences company of the United States, with a capital of 28 million US dollars and future sales share Chen Kaixian, academician of the Chinese Academy of Sciences, said that the emergence of sidabantamine has enabled China to keep pace with the international advanced level in this field and lead some in this field Sang Guowei, chief engineer of national major new drug creation technology and academician of Chinese Academy of engineering, commented that it "filled in the blank of peripheral T-cell tumor treatment drugs in China and played a positive exemplary role in the transformation and upgrading of China's biomedical industry." If there is only one innovative drug, there may be elements of luck In fact, there are many innovative achievements in the independent research and development of microchip biology, in addition to xidaban, which has been successfully listed For example, sigletta sodium in the treatment of type II diabetes has entered the clinical phase III, and theoroni in the treatment of solid cancer has entered the clinical phase I In addition to the use of sidabamide in the treatment of lymphoid cancer, new indications for the treatment of non-small cell lung cancer and breast cancer have also entered the phase III clinical In the global pharmaceutical industry, there has been a saying of "one billion dollars in a decade" - that is, it takes 10 years and one billion dollars to develop an original new drug, which is accompanied by a high risk of research and development failure In recent years, the investment has even risen to the level of $2.5 billion Since its establishment in 2001, why have so many original new drugs been developed in just over ten years? "If the mobile phone industry is' engineering driven ', then the pharmaceutical industry is' hypothesis driven'." Lu explained that a new chemical drug needs to select a useful molecular structure from tens of thousands of compounds, and every possible one needs to be tested repeatedly Most of the high investment, high risk and long cycle of original chemical new drug research and development come from this More than ten years of research and development of sidabantamine has also gone through the process of "looking for needles in a haystack" But the difference is that in the process of research and development of xidaban, the micro core organism has independently constructed a set of integrated drug innovation and early evaluation technology system based on chemical genomics, which solves the most risky link in the original drug research and development chain -- Judging the potential safety and possible clinical effectiveness of new molecular lead compounds, so as to decide whether to continue to develop or release as soon as possible Discard "When we started 15 years ago, we were in the top three in terms of technology." Lu Xianping said that the platform system effectively integrates a number of modern technologies, including computer-aided drug design, drug and combinatorial chemistry, high-throughput and high-content drug screening, chemical genomics gene expression profile research, bioinformatics and chemical informatics data mining, which can effectively accelerate the research and development process of small molecule innovative drugs and reduce the risk of new drug development It is developed by It has important technology for clinical differentiation of new drugs With this "unique secret collection", the efficiency and cost control advantages of microchip biological research and development are obvious At present, micro core biology has applied for 73 global invention patents of compounds, 45 of which have been authorized; published more than 30 papers in high-level academic journals at home and abroad; undertaken more than 30 national and provincial major scientific and technological projects It is worth mentioning that the micro core biology, which is mainly engaged in the research and development of small molecule innovative drugs, has even applied this research and development technology platform to the field of traditional Chinese medicine He participated in the "research and application of key technologies for safety of traditional Chinese medicine" project and won the first prize of 2013 National Science and technology progress award "After 60 years, we have caught up with a good era," he said Lu Xianping lamented that he and several other founders of microchip were scientists studying in the United States As college students in the early stage of reform and opening up, they were deeply benefited by the cultivation of the country They also had a common idea: they hoped to use what they learned to return to their motherland and people Lu Xianping got his doctorate in 1988 and went to the medical school of the University of California, San Diego, to be a postdoctoral researcher At that time, with the explosion of life science and technology in the United States, the emerging biopharmaceutical companies represented by Genentech were also rising rapidly "Publishing papers, setting up companies, early research, IPO, late development, being acquired, Genentech's development touched me a lot." Lu recalled that Genentech's success gave birth to a large number of venture capital, which dragged a large number of scientists from ivory tower into the factory and formed a mature innovation model from laboratory to market After emerging in the field of scientific research, venture capital, with funds, encouraged him to start a business and commercialize research results This entrepreneurial experience also promoted Lu Xianping and several other founders to make up their minds to return to China and apply the scientific knowledge and experience learned in the United States to the motherland China is a pharmaceutical power, but not a pharmaceutical power The number of nearly 5000 pharmaceutical companies is about five times that of the United States, but most of them rely on the low-level homogenization competition of generic drugs, and none of them ranks among the top 50 pharmaceutical companies in the world "Our country has very excellent scientists, a huge market and a good pharmaceutical foundation Why is the industry at the bottom of the ecological chain? Because we don't have the ability to integrate science with business, capital, market and team " Lu Xianping said With a heart full of serving the country, Lu Xianping wants to build his own "Genentech" in China Since the first round of venture capital investment of 50 million yuan, micro core has completed five rounds of financing of 400 million yuan so far, with a sustained R & D investment of nearly 1 billion yuan Now, more than ten years of effort will finally usher in a harvest With the launch of sidabamide, the sales volume of microchip biology is expected to reach 500 million yuan in the next five years If other drugs are approved successfully, it will bring at least 2 billion yuan of revenue Lu Xianping disclosed that the new R & D center and production base of microchip in Chengdu have also started in January this year, and will continue to increase investment in talents and funds, continue to cultivate core advantages, and enhance the company's international competitiveness in innovation and patented drugs The R & D mode from "Chinese imitation" to "Chinese creation" initiated by microchip also shows new possibilities for more innovative enterprises Entrepreneurs said Lu Xianping, vice chairman, President and chief scientist of microchip biology: to create a fair market environment for innovative enterprises, "innovative enterprises must follow the market rules and let the market choose freely." Lu Xianping, vice chairman, President and chief scientist of microchip biology, said, "the strong will degenerate in the greenhouse, and the market economy will be in great waves If they can't withstand the great waves, they will either die or transform." In Lu Xianping's view, the current government has put forward a lot of funds to directly support innovative enterprises, but it is more important to create a fair market environment, improve market allocation, and let enterprises survive in the competition Although enterprises need financial support at the critical moment of development, such support should also be fair and transparent first Lu Xianping suggested that in the field of biomedicine, the government should treat domestic innovative enterprises more equitably in policies such as medical insurance, so that innovative enterprises who dare to invest in independent research and development can get market returns For example, there is no similar product such as xidaban in China, but it was only included in the local supplementary medical insurance drug catalog of Shenzhen in April this year, while the national medical insurance can't go in "Many of our management systems are built according to the characteristics of traditional industries in the past, which is difficult to adapt to the development requirements of innovative enterprises." Lu said that in the future, China needs to further improve its capital market, formulate different access policies according to the characteristics of enterprises in different industries, and provide more convenient exit channels for venture capital "Only in this way can more funds be encouraged to enter the innovation fields with high risks but also high returns.".