Looking forward to 2019: Chinese Biomedical enterprises seeking a new balance point of survival and development

Looking forward to 2019 Chinese Biomedical enterprises looking for a new balance point of survival and development in 2018, Chinese pharmaceutical innovation tends to rational development In 2019, under the influence of policy reform, economic downturn and external environment changes, pharmaceutical enterprises enter a new round of adjustment and adaptation period On the whole, the survival pressure of enterprises is increasing, but innovation is still the main theme Enterprises should improve their sense of crisis, seize the opportunity of development, and find the balance between survival and development 01 deepen the reform of drug review and approval system, coordinate and coordinate efforts to promote innovation In August 2015, the State Council issued opinions on the reform of the review and approval system of pharmaceutical and medical devices, officially opening the prelude of the reform of drug supervision; in June 2017, China joined the International Coordination Conference on technical requirements for registration of human drugs (ICH), and in October of the same year, the general office of the CPC Central Committee and the office of the State Council issued opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices And encourage innovative drug research and development In recent years, some achievements have been made in the reform of drug review and approval system In 2018, a total of 48 new drugs were approved for marketing, and the time from R & D to marketing of innovative products was further shortened; in 2019, the review of new drugs will speed up the integration with international standards, especially the review and approval of drugs for clinical urgent need and treatment of rare diseases led by indications The regulatory organization was adjusted to provide organizational guarantee for comprehensively deepening the reform In March 2018, the division of food and drug regulatory functions was reorganized and the National Medical Products Administration (nmpa) was established, which belongs to the market supervision administration By the middle of 2019, the adjustment of drug regulatory organizations from the central government to the local government is expected to be completed, providing organizational guarantee for pushing forward the reform and optimization of drug review and approval policies Mah system pilot exploration regional linkage drug regulatory model launched the MAH system pilot work in 2016, effectively stimulating the innovation vitality of R & D institutions, but cross regional commissioned production challenges the existing drug regulatory system In November 2018, President Xi Jinping announced that he would support the development of regional integration in the Yangtze River Delta and upgrade it to a national strategy The biomedical industry in the Yangtze River Delta is developed, with an output value of about 30% of the country Universities and hospitals are intensive, and human resources are abundant The integration of the Yangtze River Delta will help to explore the whole life cycle supervision of drugs under regional linkage, break through the restrictions of regional segmentation, and realize cross regional supervision; at the same time, the integrated development will also help the collaborative innovation of biomedicine in the Yangtze River Delta to meet the needs of enterprise development In 2019, we will explore a sustainable model, establish a virtuous cycle mechanism, link the source supply, drug supervision and industrial chain division of biomedicine in the Yangtze River Delta, and achieve win-win cooperation, so as to create a distinctive biomedical innovation ecosystem, which will provide experience for the linkage development in Beijing, Tianjin, Hebei, Pearl River Delta and other regions in the later stage, and lay a foundation for the comprehensive promotion and implementation of MAH The consistency evaluation work continued to advance, and the procurement policy with volume should be adjusted and optimized In 2016, the consistency evaluation work of generic drugs was started In view of the slow progress of the evaluation work of 289 basic catalogues, at the end of 2018, the FDA cancelled the time limit requirements for the evaluation of the original essential drugs The evaluation methods and routes are not clear, the reference preparation and other related supporting measures are introduced late, high-quality clinical trial bases and clinical trial doctors are insufficient, and the progress is slow due to the high cost of evaluation In September 2018, under the guidance of the National Medical Insurance Bureau, the requirements and operation methods of 4 + 7 volume purchase were determined It is hoped that the cost of intermediate links will be reduced through volume purchase, drug price will be promoted, and medical insurance expenditure will be reduced However, the effect of the initial implementation of volume procurement remains to be discussed Many enterprises originally expected to improve the quality of generic drugs through consistency evaluation, and to achieve a new way of enterprise development by improving product level through technology However, the low drug price caused by the current trial volume procurement has worried the enterprises about future development Whether it is short-term product quality improvement or long-term drug innovation, enterprises need to invest a lot of money Therefore, how to achieve a balance between reducing drug prices and making pharmaceutical enterprises have reasonable profits, so that enterprises have the ability to invest more in innovation and R & D must be considered in the process of policy formulation and implementation; relevant policies among government departments should be considered as a whole for coordination and linkage, so that a series of policies do not violate the original intention and achieve the best effect In 2019, the relevant departments shall review and summarize the preliminary implementation results of 4 + 7 volume procurement and make corresponding adjustments The construction of clinical base and the training of clinical trial doctors are expected to be further strengthened, and the standardization of clinical trials and the design and implementation capacity of innovative drug clinical research are expected to be further enhanced, so as to improve the effectiveness of innovative research and development 02 the capital market adjusted the changes of external environment, and the venture capital of biomedical enterprises rationally and calmly developed biomedical industry grew rapidly in the past few years, which provided a lot of financial support for start-ups and innovation transformation In 2018, the economic downturn and the overall investment are gradually tightening At the same time, investors also need to evaluate the investment benefits of the previous years and make corresponding adjustments It is expected that in 2019, the venture capital and investment and financing of biomedicine in Chinese market will further slow down, investors will become more "calm and smart", and the market mechanism will be more mature This will further promote the healthy development of China's biopharmaceutical industry, and will be more beneficial to high-quality varieties, technologies and enterprises, which still have the opportunity to obtain sufficient funds and stand out The outbreak of Sino US trade friction in 2018 will also have an impact on the biomedical industry Talent exchanges and investment between the two countries have been affected If the trade friction is long-term, it will have a wider adverse impact on personnel exchange, information exchange and two-way investment, and will have a potential impact on outsourcing service enterprises It is a gradual process for pharmaceutical enterprises to speed up the layout and innovation strategy, and to combine imitation and innovation with a long-term plan to jointly innovate the innovation and development of Chinese Biopharmaceutical Enterprises In the short term, it is a relatively reliable path for the survival and development of enterprises to improve the quality of products by improving the technical content; in the long term, it is the only way for enterprises to grow larger and stronger by increasing the investment in R & D and strengthening the proportion of innovative drugs pipeline Technological innovation of generic drugs, the transformation of Chinese pharmaceutical enterprises from manufacturing enterprises to technological innovation enterprises, are experiencing the transformation from manufacturing enterprises to technological innovation enterprises, from low-level replication to high-standard manufacturing, and further transition to technological upgrading and innovative R & D In the process of research and development of generic drugs, we should improve the level of preparations, control the quality of products, ensure the safety and effectiveness of products, scientifically verify the efficacy and quality consistency of generic drugs and original drugs; through technological innovation (crystal research, application of the latest preparation materials and technologies), we should better improve the safety and effectiveness of existing drugs, improve the dosage forms, and improve the convenience of patients' use Compliance It is the only way for pharmaceutical enterprises to be bigger and stronger to innovate drug R & D, increase R & D investment and expand production university research cooperation and innovation R & D In 2018, the R & D investment of pharmaceutical enterprises is on the rise, and innovative enterprises with strength have achieved good results by increasing R & D investment Under the influence of national policy guidance and market changes, Chinese pharmaceutical enterprises will further accelerate the strategic layout of innovative drug research and development in 2019, and accelerate the transformation and upgrading of enterprises from product structure, talent team, capital support and other aspects It is expected that the overall proportion of R & D investment in 2019 will continue to grow; in the context of differentiated innovation, the willingness and demand of enterprises for innovative R & D will further increase; the mode of cooperation between enterprises, universities and research institutes will be more diversified, and the division of labor between enterprises, universities and research institutes will be more clear and reasonable, and universities and research institutes will provide more sources of innovation for enterprises through breakthroughs in basic research New varieties and technologies The cross integration of AI and new drug R & D will bring a revolutionary breakthrough to biomedical innovation Artificial intelligence has been widely used in disease mechanism research, new drug target discovery, structural biology and all kinds of life group research; meanwhile, it plays an increasingly important role in computer-aided drug design, structure-activity relationship research, ADMET prediction and evaluation, and the search for the best crystal form; all kinds of wearable artificial intelligence devices also play a great role in promoting clinical research Effect In the next few years, the application of artificial intelligence in all stages of drug research and development will become increasingly significant 04 2019 new drug focus: new drug gv-971 for Alzheimer's disease treatment is expected to be approved In July 2018, Green Valley pharmaceutical announced that its Alzheimer's disease treatment drug gv-971 (hsh-971) has completed phase III clinical trials, and achieved the expectation on the main efficacy indicators of cognitive function improvement Green Valley pharmaceutical submitted a new drug listing application to nmpa in October Gv-971 is expected to be approved in 2019 to achieve a breakthrough in the treatment of Alzheimer's disease PD-1 / PD-L1 approved new drugs increased and promoted the price of similar drugs to fall Tereprizumab and Cinda's sindilimab were approved for market successively at the end of 2018, bringing more choices for tumor immunotherapy In the middle of 2019, more PD-1 / PD-L1 drugs will be approved, and the listing of several similar tumor immunotherapy drugs will form a benign competition pattern, which will have a positive impact on reducing drug prices and improving the accessibility of innovative drugs Differentiation will be the key to the success of drugs in the future drug research and development, and the joint application of PD-1 / PD-L1 drugs and small molecule drugs is expected to occupy part of the market Conclusion: China's biomedical industry is developing rapidly and the market is becoming more and more mature The continuous reform and optimization of the drug review and approval system provides a good environment for further innovation and development of the biomedical industry In 2019, China's biomedical development will face difficulties and challenges, but opportunities are the same Finding a balance point is the key to a new round of development.