2019 biomedical trend: investment in targeted drugs and antibody drugs holds the top position

For the biological and pharmaceutical industries, 2018 is another extraordinary year According to the arterial network database, 1410 transactions involving US $38.801 billion occurred in the field of global health care in 2018 Among them, the biological and pharmaceutical industry is the absolute mainstream of the times: 309 trading events, with a financing amount of US $13.845 billion, it is far ahead of other industries without any suspense, and once again holds the top position in medical and health investment and financing But on the other hand, the world is experiencing a capital winter in 2018, and many people are speculating that the start-ups will be more difficult in 2019 No matter capital or enterprise, every step is particularly important Those who make the right judgment on the situation will certainly be able to go further in the process For this reason, aoxinpharma re extracted and sorted out the investment and financing events of the global biomedical industry in 2018 and the drug approval situation of China and the United States from the 2014-2018 new pharmaceutical investment and financing data report It is hoped that the data can be used to predict the development trend of biomedicine in 2019 and provide reference for practitioners Targeted and antibody drug investment is the top priority From 2014-2018 investment and financing data, antibody drugs, targeted drugs, gene detection, immunotherapy and special disease drugs are currently the most capital focused subdivision areas Among them, antibody drugs \ targeted drugs have been ranked the top of the investment and financing hot list with the financing amount of US $6.064 billion There are 40 investment and financing events of antibody drugs / targeted drugs, with an average of US $billion for each financing event, which is a frequent place for high-value financing In recent years, the research and development of tumor innovative drugs has been regarded as the investment hotspot of the new round of drug research and development The targeted drugs can act on the specific target of tumor growth, and can intervene the tumor under the condition of less damage to normal cells; the antibody drugs also use the targeted, disease development pathway to intervene the disease, with higher targeting and efficacy The first targeted drug was approved in 1997 Now targeted drugs and antibody drugs have become an important treatment for clinical tumor drugs They may be able to really achieve the goal of transforming this malignant disease into chronic disease However, it is precisely because these two drugs have been widely used in clinical practice that most enterprises have entered the middle and late stage of development With fierce competition and high corporate valuation, most of the institutions focusing on early investment may not choose to enter the market again; for those focusing on later investment, it is the harvest season The total number of investment and financing for specific diseases is 75, which is currently the most subdivisional area of investment and financing events Most of these diseases are related to tumors, cardiovascular diseases and neurodegenerative diseases In recent years, the research and development of cardiovascular disease and tumor drugs has been a hot investment In contrast, Alzheimer's research is more cutting-edge Similar to diabetes and cardiovascular disease, the risk of Alzheimer's disease increases with age With the aging of the population, the social burden caused by diseases of the elderly is more and more prominent The difference is that although diabetes is still incurable, there are controllable drugs So far, the pathogenesis of Alzheimer's disease is not clear, and there are no therapeutic drugs available It can be said that Alzheimer's disease, as the life span of the global population is greatly extended, has swept every corner of the earth, and is one of the few diseases that human beings are still at a loss to deal with at present In November 2017, Bill Gates invested $100 million in the treatment and research of Alzheimer's disease in his own name He will invest $50 million in venture capital fund dementia Discovery Fund, and another 50 million in Alzheimer's research start-ups In 2018, 27 enterprises obtained financing related to Alzheimer's disease Johnson & Johnson, Eli Lilly, Wuxi apptec, Pfizer, arch venture, Sequoia, OrbiMed and other well-known pharmaceutical companies and leading institutions invested nearly $500 million The long market gap has brought two sides, one is the patient's anxious waiting, the other is unprecedented opportunities In recent years, major findings of Alzheimer's disease related research are frequent, leading institutions focusing on early investment in life science have begun to make moves, and for institutions focusing on cutting-edge technology, they have entered a planning period The wave of gene therapy is coming, and it's necessary to seize the opportunity In October 2017, the listing of spark company luxturna made companies and capital in the whole field of gene therapy fall into a carnival The first real gene drug finally landed on the market, so more capital and start-up companies entered the market On the enterprise side, according to the 2018 global gene therapy research report of Jain pharmabiotech, the world's top think tank, more than 183 companies are engaged in gene therapy research, more than four times the number in 1995, and more than 2000 clinical projects The clinical research of gene therapy can be traced back to the 1990s Due to the limitations of early technology and lack of recognition of disease, the development of gene therapy technology has been unsatisfactory With the improvement of gene cutting, virus vector and other basic technologies, and the improvement of people's cognition of diseases and tissues, the safety and effectiveness of gene therapy are beginning to mature First, spark, a new cutting-edge company, made a breakthrough Then, Zhang Feng, David Liu, and J Keith joung, three top scientists in the field of gene editing, jointly founded beam therapeutics, a gene therapy research company Later, editas medicine, another gene editing company in which Zhang Feng participated, announced that it was approved to carry out the clinical trial of Leber congenital amaurosis 10 (lca10) After 30 years of setbacks, gene therapy technology is developing rapidly and becoming a powerful weapon to break through various genetic and acquired diseases Genetic immune system diseases, blood diseases, neurodegenerative diseases and so on, are also difficult to break through in the field of biological and chemical drug research According to the arterial network database, in 2018, 17 global gene therapy companies obtained financing, and the capital invested US $1.7 billion in this field Although most of the investment and financing events take place overseas, we can also see that leading investment institutions such as Lilly Asia and IDG have quietly launched several rounds of layout in China Gene therapy has already set off a trend overseas, which is bound to quickly sweep the domestic market Capital support provides fuel for the industry to move forward, but the role of policies and approvals can not be ignored When a new technology is recognized from the regulatory level, the industry will inevitably get more human and material resources, and there will be more, policy approval plays a leading role in the industry Therefore, to predict the future development, the annual drug approval of regulatory authorities is also worth studying China's market: the approval is accelerated and 8 new drugs have been approved In the whole year of China's nmpa, 8 new drugs have been approved, namely, ibuprootein, enrotinib, tiopefigistin, danorevir, pyrrolidine, furaquinidine, treprizumab and cindilimab Since the announcement on self inspection and verification of drug clinical trial data was issued in July 2015, regulatory authorities have raised requirements on drug clinical trial and application, which can be regarded as "the most stringent in history" After that, the enterprises with "hard core technology" can highlight the siege and enter the capital vision The approval of these drugs in 2018 is regarded as the first results after many years of gestation In addition to the improvement of drug quality, we can also see the improvement of regulatory authorities in the speed of drug approval From 674 days of ibowetai (hosted in July 2016) to 252 days of cindilimab (hosted in April 2018), we can see the positive attitude of regulatory authorities on major innovation and drugs with urgent social needs This series of measures have given more confidence to capital and enterprises to continue to develop innovative domestic good drugs Not only has the number of new drug approvals increased, but the number of ind accepted by nmpa this year has also reached a record in the past 15 years According to Changjiang Securities Research Institute, in 2018, the number of domestic inds reached 224, an increase of 71% compared with 131 in 2017 The picture comes from the two-way improvement of the application quantity and efficiency of Changjiang Securities Research Institute, and the strict control of data quality in the whole process, which will usher in the breakthrough of new drug quantity in a certain period of time 2018 is regarded as the first year of the rise of China's innovative drugs The drugs approved in this year are only the beginning It is believed that more drugs with clinical value will enter the market in the next few years In 2019, there are 15 domestic new drugs that are expected to be launched in 2018 It is expected that in 2019, the number of domestic new drugs approved will be further increased, and the results of new drug creation will appear from 2018 According to the data of Changjiang Securities Research Institute, it is estimated that the rate of domestic new drugs approved in 2019 will be more than 10, among which the number of anti-tumor drugs is the largest, which is expected to reach 7 34 orphan drugs in the U.S market have been approved for marketing The R & D of rare disease drugs deserves attention Throughout the global market, FDA approved 59 new drugs in 2018, breaking the record for 20 years Of the 59 new drugs, 34 were approved as orphan drugs In 2018, FDA approved for the first time a kind of treatment drug for rare genetic chondropathy, Fabry's disease (rare serious disease, which can cause many adverse symptoms), phenylketonuria (rare disease, patients can't decompose the food containing protein and sweetener, which will cause brain and nerve damage) For market reasons, pharmaceutical companies do not attach importance to the development of orphan drugs The United States began to legislate in 1983 and passed the first Orphan Drug Act (ODA) in the world The bill is based on the protection of orphan drug R & D enterprises in terms of market monopoly and clinical priority, and provides convenience for orphan drug R & D enterprises through exemption of application fees, provision of research funds and rapid approval channels In addition to the United States, the European Union, Japan, Australia, Singapore and other regions have also promulgated orphan drug laws The emergence of these laws has greatly promoted the development and marketing of orphan drugs The research and development of new drugs are affected by many factors, such as the difficulty of research and development, the patent period of drugs, generic drugs and so on, while the research and development of rare disease drugs often perform well due to less competition in policy protection For example, the main sales source of new base pharmaceutical industry is based on its rare disease drug Revlimid, with annual sales of 8.187 billion US dollars (2017) In the same year, the sales volume of MSD PD-1 was less than 1 / 2, which was $3.809 billion Under the background of rising R & D cost and increasingly strict approval requirements, research and development of rare disease drugs has become the choice of pharmaceutical companies A large number of pharmaceutical enterprises, such as Roche, Xinji pharmaceutical, BMS, Novartis, Aberdeen and Johnson & Johnson, have a considerable part of their R & D expenses for the research and development of rare disease drugs every year Takeda Pharmaceutical Co., Ltd of Japan acquired rare disease giant shire Pharmaceutical Co., Ltd in 2018 with us $64 billion Takeda has offered offer letters to shire for five times Coincidentally, in 2019, BMS acquired the new base pharmaceutical industry, with a transaction value of US $74 billion With the increasing indications of orphan drugs, there are more and more heavy bomb drugs such as eculizumab, imatinib mesylate (Lenin) and revimid E