"13th Five-Year Plan" on the occasion of China's class 1 chemical new drug progress and trend? (Top)

article from:Firestone Creation Research Institute, author: Sun Xiangyu, picture from "123RF"2020 is China's "13th Five-Year Plan" year, looking back over the past five years, China'sbiopharmaceutical industryhas undergone great changes, the innovative properties of industrial development significantly enhancedFrom the perspective of class 1 chemical new drugs, the author interprets the progress of theof biopharmaceuticalindustry innovation in the past five years, and on this basis, makes a brief outlook on the future innovation of chemical drugsMarch 2016, the State Administration of Food and Drug Administration issued the Announcement on the Work Programme for the Release of The Reform of the Classification of Chemical Drugs Registration (No51 of 2016), which adjusts the classification categories of chemical drugs registration, dividing new chemical drugs into 1 new drug and 2 new drugs, and 1 category: no innovative drugs listed at home or abroadRefers to a drug that contains a new structured compound with pharmacological effects and has clinical valueThe new registration classification method, so that class 1 chemical new drug has a "global new" attribute, the innovation gold content greatly increaseddue to the improvement of the policy environment of new drug creation, the introduction of innovative talents, the increase of innovation input and the innovation of innovation mode, China's innovative drugs in the "13th Five-Year Plan" period ushered in a golden period of rapid developmentThe last article on the research and development of class 1 chemical new drug presents the following characteristics:characteristics One: Class 1 chemical new drug policy environment can be fundamentally improved, encourage the policy throughout the life cycle of clinical research and development, review and approval, production and manufacturing, medical insurance payment and other drugs2015, the State Council issued the Opinions on Reforming the Review and Approval System for Drug Medical Devices (Coffa (2015) No44), thus opening the door to China's new drug incentive policyOn December 1, 2019, the newly revised Drug Administration Law of the People's Republic of China came into effect, and the results of the new drug incentive policy practice in the new period of china were determined in the form of lawThe reform of China's new drug policy to review and approval system as a breakthrough, gradually covered to clinical trial management, intellectual property protection, drug market licensing holder system (MAH) pilot, innovative drugs into the medical insurance drug catalog and other industrial links, thus, China's new drug creation policy environment has been fundamentally improvedFeatures II: 1 class of new chemical drug research and development enthusiasm is high, domestic enterprises, global pharmaceutical enterprises have increased the number of innovative research and development
according to the State Drug Administration Drug Review Center (CDE) to accept the first class of new chemical drug clinical trial application (IND) and new drug listing application (NDA), domestic and international pharmaceutical companies are China as a hot land for new drug research and development, have been in the domestic layoutFirestone Creation Database shows that the number of applications for class 1 chemical new drugs in China increased overall from 2016 to May 20, 2020, reaching 400 in 2019, the peak of recent declarationsUnder the background of the global spread of the new crown epidemic, the research and development of class 1 chemical drugs in China is still hot, with nearly 190 acceptance numbers from January to May 20, 2020from 2016 to May 20, 2020, the proportion of applications for listing (NDA) for class 1 new chemical drugs was 5.8%The annual share fluctuated considerably, from 2.2 per cent in 2016 to 10.9 per cent in 2018, before falling to 3.2 per cent in 2020From 2016 to May 20, 2020, the number of applications for imported new chemical drugs (1, 5.1) increased overall, with 329 acceptances in 2019, the peak of recent declarationsAgainst the backdrop of the global spread of the new crown epidemic, applications for new drugs will fall significantly in 2020 compared with 2019During the "13th Five-Year Plan" period, the number of new chemical drugs imported 5.1 has been increasing, and more and more drugs already on the market abroad will accelerate the domestic marketIn the past two years, the proportion of applications for imported class 1 chemical new drugs has risen to about 50%, indicating that more and more international enterprises are beginning to carry out research and development layout simultaneously in China, and that in the future, the "domestic and foreign market time difference" of new drugs will be greatly compressedFeatures 3: Class 1 chemical new drug treatment field focused on tumor, HIV, hepatitis C and cardiovascular and cerebrovascular, immune system diseases, a number of clinical urgent needs, to fill the gap in the domestic market of heavy products came outin the three years 2016-2018, new drug indications approved for clinical trials presented a pattern of aggregation of anti-tumor drugsIn the first three therapeutic areas, anti-tumor drugs accounted for 44.3%, digestive drugs accounted for 12.2%, endocrine system drugs accounted for 7.2%, the total share of the three more than 60% On May 20, 2016, CDE approved a number of heavy chemical drugs The field of new drug treatment is concentrated in anti-tumor, HIV, hepatitis C, type 2 diabetes and rare diseases in anti-tumor drugs, multi-targeted tyrosine kinase inhibitors for advanced or metastatic non-small cell lung cancer and soft tissue sarcoma have emerged with the drug anrotinib, oral epidermal growth factor receptors (EGFR) and HER2 tyrosine kinases for recurrent or metastatic breast cancer, and new high-selective endothelial datinoid serotonin inhibitors for metastatic colorectal cancer Anrotinib is the first soft tissue sarcoma targeted drug in China, and has been qualified by the FDA for the orphan drug of soft tissue sarcoma After The Aloitini was approved for listing in 2018, sales reached RMB1.28 billion in the near half year, with sales estimated at RMB3 billion for the full year of 2019 in viral hepatitis, AIDS, influenza and other major viral infections related to the treatment of drugs, Abouveta is the first, the world's second anti-AIDS long-acting drugs, the main epidemic of HIV-1 virus and drug-resistant viruses are effective, with high safety, small side effects and other advantages Danorivir sodium is the first local lyuk drug for the treatment of chronic hepatitis C in China, and is a specific target anti-hepatitis C virus drug with a new mechanism of action , class 1 new drug coriander is a drug for upper respiratory tract infections caused by drug-resistant Gram-positive bacteria, pneumocoplasma, chlamydia, etc., with high oral absorption, small dose, incidence of adverse reactions and low induced drug resistance The chronic renal anemia drug rosacea is the first global simultaneous development and China's first class 1 drug, the world's first small molecule low-molecule low-oxygen-induced factor procophexamperase inhibitor class to treat renal anemia For psoriasis drug Benvimode, is the world's first therapeutic aromatic hydrocarbon receptor regulator class, non-hormonal small molecular chemical drugs, can be multi-pathway inhibited psoriasis pathogenesis, the efficacy is accurate, the recurrence rate is low characteristics four: 1 class of chemical new drug innovation main body into the head of large enterprises, minimally invasive enterprises and research institutes, "three-legged" trend, research and development service system is constantly improving large-scale innovative drug research and development enterprises early through cooperation with research institutes, universities to develop new drugs, enterprises attach importance to research and development team building, new drug research and development investment, at this stage the enterprise's innovative drug pipeline has begun to take shape on behalf of enterprises have Hengrui Pharmaceuticals, Haussen Pharmaceuticals, Zhengda Tianqing, Stone Pharmaceutical Group, Beda Pharmaceuticals, Dongsun Pharmaceuticals and so on minimally invasive enterprises through the financial market to obtain financial support, focus on a treatment field, mainly anti-tumor drugs, research and development team members with overseas research background or multinational pharmaceutical enterprise background, research and development products for the world, independent research and development, introduction and development (such as license-in), cooperative outsourcing and other ways to develop new drugs, on behalf of enterprises have Suzhou Zeyu Biology, Nanjing Sanhe Pharmaceutical, Guangdong Shisheng Pharmaceuticals, Keystone Pharmaceuticals, Hutchisun Whampoa, Green Valley Pharmaceuticals, Research Institute, represented by the Shanghai Institute of Medicine of the Chinese Academy of Sciences, the Institute of Pharmaceutical Research of the Chinese Academy of Medical Sciences, the Shanghai Pharmaceutical Industry Research Institute, the Chinese Pharmaceutical University, Shenyang Pharmaceutical University and Sichuan University, has strong research and development strength, and usually cooperates with enterprises in the development of innovative drugs In the tide of new drug development in China, a large number of specialized sub-outsourcing services (CRO/CDMO) emerged For example, in the production process, under the pilot of the listing license holder (Marketing authorization holder, MAH) system, pharmaceutical companies can entrust production enterprises to be responsible for the production of innovative drugs, such as Hutchison Whampoa's furry martini, Golipharmaceutical's Danoriwe Sodium have commissioned the pharmaceutical company Mingkang subsidiary Shanghai Hequan Pharmaceuticals to be responsible for production, eliminating the self-built plant and production line of capital and time, thereby accelerating the listing of new drugs In addition, collaboration and development by pharmaceutical companies, universities, research institutes, and contract research organizations (CRO) can reduce the risks and costs of innovative drugs through risk sharing China's CRO / CDMO field head enterprises include pharmaceutical Mingkang, Kanglonghuacheng, Tyger Pharmaceuticals, Kelelion, Boateng shares, Pharmaceutical Stone Technology, ZhaoYan new drugs and Medixi and so on As the leader in the CRO field in China, the company's revenue in 2019 was RMB12,872 million, up 33.89 percent year-on-year Kang Longhuacheng and Tag Pharma ranked second and third in revenue, with 3.757 billion yuan and 2.803 billion yuan, respectively Kelelion and Boateng's shares have revenues of more than 1 billion yuan, while Pharmaceutical Stone Technologies and Zhaoyan New Drugs have revenues of 5-1 billion yuan, while Medixi's revenue is less than 500 million yuan 2019, the average gross margin of eight core CRO enterprises, such as Pharmaceutical Mingkang, Kanglonghuacheng and Tag Pharma, was 40.47 percent Among them, the gross margin of ZhaoYan new drugs and pharmaceutical stone technology was higher, both exceeding 50%, and the gross margin of Kanglonghua was the lowest, at 35.52% The gross margin of Zhaoyan new drug is higher than that of other enterprises, mainly because it has a strong bargaining power as a leading domestic enterprise, while pharmaceutical stone technology is due to the uniqueness of the molecular blocks provided, high-tech barriers and low labor costs lead to a high level of gross margin of its products Clinical CRO is the sub-industry with the highest value and the highest technical content in the service outsourcing industry Tiger Pharma as a leading domestic clinical CRO track, the compound growth rate of profits in the past 3 years as high as 80%, far more than the industry peers after the "13th Five-Year Plan" period of efforts, China's first class of chemical drugs research and development has a solid foundation On this basis, the "14th Five-Year Plan" chemical new drug development will usher in greater development opportunities? The next part of this article will focus on the analysis of industrial trends Stay tuned!