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

TextsSun Xiangyu2020 is China's "13th Five-Year Plan" year, looking back over the past five years, China's biopharmaceutical industry has undergone great changes, the innovative properties of industrial development significantly enhancedThe author from the perspective of class 1 chemical new drugs, to interpret the past five years of biopharmaceutical industry innovation progress, on this basis, the future chemical innovation to do a brief outlookIn March 2016, the State Administration of Food and Drug Administration issued the Notice on the Publication of the Work Programme for the Reform of the Registration of Chemical Products (No51 of 2016), and Announcement No51 adjusted the classification of chemical scos registers, dividing new chemical drugs into 1 new drug and 2 new drugs, and 1 category: innovative drugs that are not listed both at home and abroadRefers to a drug that contains new well-structured compounds with pharmacological effects and clinical valueThe new registration classification method, so that class 1 chemical new drugs with "global new" properties, the innovative gold content greatly improveddue to the improvement of the policy environment of new drug creation, the introduction of innovative talents, the increase of innovative investment and the innovation model of innovation, China's innovative drugs in the "13th Five-Year Plan" period ushered in a golden period of rapid developmentThe above analysis of the characteristics presented in this paper on the research and development of a class of chemical new drugs is as follows:the State Council issued the Opinions on Reforming the Review and Approval System of Medical Devices of Pharmaceutical Medicines in 2015 (National Development (2015) No44), thus opening the beginning of China's new drug incentive policyThe newly revised Drug Administration Law of the People's Republic of China, which was revised on December 1, 2019, came into effect, and the results of the new drug incentive policy practice in China were determined in the form of lawChina's new drug policy reform to review and approval system as a breakthrough, gradually covering 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 improvedAccording to the application for clinical trials (IND) and new drug marketing (NDA) for a class of chemical new drugs accepted by the Drug Review Center (CDE) of the State Drug Administration, both domestic and international pharmaceutical companies regard China as a hot land for new drug research and development and are in the domestic distributionFirestone Creation Database shows that from 2016 to May 20, 2020, the number of applications for a class 1 chemical new drug in China increased overall, reaching 400 in 2019, a peak in the near-stage filing Under the background of the global spread of the new crown epidemic, the research and development heat of Class 1 chemical drugs in China is still not reduced, with nearly 190 acceptance numbers from January to May 20, 2020 In terms of the type of acceptance, the proportion of applications for new chemical drugs (NDA) for Class 1 chemicals was 5.8% from 2016 to May 20, 2020 The annual ratio fluctuated considerably, from 2.2 per cent in 2016 to 10.9 per cent in 2018, before falling to 3.2 per cent in 2020 From 2016 to May 20, 2020, the number of applications for new imported chemical drugs (Class 1, Category 5.1) increased overall, with 329 acceptance numbers in 2019 reaching a peak in the recent stage Under the background of the global spread of the new crown epidemic, the application for imported new drugs in 2020 will have a significant decline compared with 2019 During the "13th Five-Year Plan" period, the number of new imports of 5.1 chemical drugs has been increasing, and more and more drugs already listed abroad will speed up the domestic market In the past two years, the proportion of applications for new chemical drugs imported in class 1 has risen to about 50%, indicating that more and more international enterprises are beginning to carry out simultaneous research and development layout in China, and in the future, the "domestic and foreign time difference" of new drugs will be greatly compressed In the three years from 2016 to 2018, new drug indications approved for clinical trials are presented as a pattern of convergence of anti-tumor drugs In the top 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 proportion of the three accounted for more than 60% From 2016 to May 20, 2020, CDE approved a number of new heavy chemical drugs The treatment of new chemical drugs focuses on anti-tumor, HIV, hepatitis C, type 2 diabetes and rare diseases in anti-tumor drugs, emerging new high-selective endothelial endothelial cell growth factor (VEFR) inhibitors for late-stage or metastatic non-small cell lung cancer and soft tissue sarcoma, the multi-target tyrosine kinase inhibitor drug antitinet acid and anti-biotaine inhibitor hydrochloric acid, oral epidermal growth factor receptor (EGFR) for recurrent or metastatic breast cancer, and new highly selective endothelial cell growth receptors for metastatic colorectal cancer .212 Arottinib is China's first soft tissue sarcoma targeted drug, the U.S FDA granted soft tissue sarcoma orphan drug eligibility After The company was approved for listing in 2018, sales of nearly half-year reached 1.28 billion yuan, with full-year sales estimated at 3 billion yuan in 2019 in viral hepatitis, AIDS, influenza and other major viral infections related to the treatment of drugs, Albevetai is the first domestic, the world's second long-term anti-AIDS drugs, the main epidemic of HIV-1 virus and drug-resistant virus essometric, with high safety, small side effects and other advantages Danorevir sodium is the first locally developed new class 1 drug to treat chronic hepatitis C by local, and is a specific target drug against hepatitis C virus with a new mechanism of action in addition, , a class 1 new drug, colycin, is an upper respiratory tract infection caused by drug-resistant gramobacteria, mycoplasma pneumoniae, chlamydia, etc., with high oral absorption, small dose, incidence of adverse reactions and low rate of induced resistance For the chronic renal anemia drug rosastas, is the first global synchronous development, China's first new drug, the drug is the world's first small molecule hypoxoxaline-induced agent prosyloconosis inhibitors to treat renal anemia For psoriasis drug Benvimode, is the world's first therapeutic aromatic hydrocarbon receptor regulator, non-hormonal small molecular chemical drugs, can multi-channel inhibit the onset of psoriasis, the efficacy is accurate, the recurrence rate is low Table 1 2016-May 20, 2020 CDE approved the market of heavy chemical new drugs
Large-scale innovative drug research and development enterprises early through research institutes, universities to develop new drugs, enterprises attach importance to research and development team building, new drug research and development investment, the current stage of the enterprise's innovative pharmaceutical pipeline has begun to take shape on behalf of enterprises such as Hengrui Pharmaceuticals, Howson Pharmaceuticals, Zhengda Tianqing, Stone Pharmaceutical Group, Beida Pharmaceuticals, Dongsun Pharmaceuticals and so on micro-enterprises through the financial market to obtain financial support, focusing on a certain area of treatment, 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, to 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 Zebio, Nanjing Sanhe Pharmaceuticals, Guangdong Zhongsheng Pharmaceuticals, Keystone Pharmaceuticals, Hutchison Whampoa, Green Valley Pharmaceuticals, Research Institute, represented by the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences, the Institute of Pharmaceutical Research of the Chinese Academy of Medical Sciences, the Shanghai Institute of Pharmaceutical Industry, the Chinese University of Pharmacy, Shenyang Pharmaceutical University and Sichuan University, has strong research and development strength and usually cooperates with enterprises in the development of innovative drugs Form 2 2016-May 2020 CDE accepts applications for class 1 chemical new drugs (acceptance number s5) In the tide of domestic new drug development, a large number of specialized sub-outsourcing services (CRO/CDMO) emerged For example, in the production sector, under the marketing license holder (Marketing holder, MAH) system pilot, pharmaceutical companies can entrust manufacturers responsible for the production of innovative drugs, such as Hutchison Whampoa's furanitinib, Golipharmaceutical's Danoriwe sodium are entrusted to the pharmaceutical company Ming Conde subsidiary Shanghai Hequan Pharmaceuticals to be responsible for production, eliminating the cost of self-built plant and production lines and time, thereby accelerating the listing of new drugs In addition, the development of collaboration between pharmaceutical companies, universities, research institutes, and contract research organizations (CROs) reduces the risks and costs of innovative drugs through risk sharing China's CRO/CDMO field head enterprises include Pharmaceutical MingKangde, Kanglong Huacheng, Tiger Pharmaceuticals, Kailaiin, Boten shares, Stone Technology, Zhaoyan new drugs and Medici As china's leader in the CRO field, pharmaceutical Mingkang de as China's cro is a leader in 2019 revenue of 12.872 billion yuan, an increase of 33.89 percent year-on-year Kanglong Huacheng and Tiger Pharma ranked second and third in revenue, at 3,757 million yuan and 2.803 billion yuan, respectively Kelley and Boateng shares in revenue of more than 1 billion yuan, Pharmaceutical Sco and Zhaoyan new drug revenue of 5-1 billion yuan, Medici's revenue of less than 500 million yuan 2019, the average gross margin of eight core CRO enterprises, including Pharmaceutical Conde, Kanglong Huacheng and Tiger Pharma, was 40.47% Among them, Zhaoyan new drugs and pharmaceutical stone technology's gross margin is higher, both exceeded 50%, Kanglong into the lowest gross margin, 35.52% The gross profit margin of Zhaoyan new drugs is higher than that of other enterprises, mainly because of its strong bargaining power as a leading enterprise in China, while the pharmaceutical stone technology is due to the molecular block provided by a certain uniqueness, high-tech barriers and low labor costs resulting in a high level of gross margin of its products Clinical CRO is the service outsourcing industry with the highest proportion of value and the highest technical content of sub-industry Tiger Pharma as a leading domestic clinical CRO track, the compound growth rate of profits in the last 3 years as high as 80%, far exceeds that of industry peers Table 3 China's pharmaceutical outsourcing of various sub-sectors of the market and competition
After the "13th Five-Year Plan" period of efforts, China's class 1 chemical research and development has a solid foundation On this basis, "14th Five-Year Plan" chemical new drug development will usher in greater development opportunities? The next part of this paper will focus on the analysis of industrial development trends Stay tuned!