The research and development soil of domestic innovative drugs is increasingly fertile, and the industry has entered an accelerated mode

[pharmaceutical network market analysis] the policy dividend was implemented, and domestic innovative drugs entered the accelerated mode Industry insiders said that in order to encourage innovation, the State Food and drug administration has taken a series of measures, including reforming the management of clinical trials, scientifically accepting the data of overseas clinical trials, and encouraging the simultaneous listing of new drugs at home and abroad On the premise that the standards are not lowered, the time of listing of new drugs at home and abroad urgently needed in clinical practice in China has been greatly shortened China's innovative drug R & D soil is increasingly fertile (photo source: pharmaceutical network) The industrial policy end, which is constantly improved and supported, has created a soil for pharmaceutical enterprises to develop innovative drugs On the one hand, the key distribution varieties of domestic innovative drug companies have entered the harvest period, such as the listing of four domestic PD-1 monoclonal antibodies of androtinib of Zhengda Tianqing, 19-k of Hengrui medicine; on the other hand, the rapid access of foreign innovative drugs into the domestic market has been opened, and the speed of listing has increased, and the research and development of domestic innovative drugs is in the ascendant Thanks to the echelon of new products under research built by continuous R & D investment, many companies will enter the harvest period in 2020 At the same time, with the formal implementation of the new version of the medical insurance catalog, new drug products included in the medical insurance catalog will also usher in large sales volume through "price for volume" For example, an enterprise said that the company has made important progress in a number of clinical trials in the field of bio innovative drugs The phase II clinical trial of puyouke thrombolytic therapy for acute pulmonary embolism, a national first-class biological new drug, was successfully completed; the clinical trial of recombinant oncolytic vaccinia virus injection T601 was being carried out, and the drug administration of subjects in phase I / IIa clinical trial was successfully completed With the continuous progress of technology, a lot of high technology has begun to empower the research and development of innovative drugs For example, the above-mentioned enterprises explored gene technology, artificial intelligence, biomedical big data earlier It is reported that through the application of these high technologies to enable R & D, the enterprise integrates the advantages of modern Chinese medicine, chemical medicine and biological medicine collaborative development, and is building disease solutions in three fields of cardio cerebrovascular, digestive metabolism and anti-tumor for the future In 2019, the dividend of drug regulatory reform will continue to be released The review and approval process was further optimized, with 10 new drugs of category 1, 16 new drugs urgently needed abroad in clinical practice, 19 innovative medical devices approved for listing, 10 priority reviewed medical devices successfully listed, and domestic innovative drugs showing a positive trend However, the development of innovative drugs is still a high-risk activity It is understood that with the refinement of industrial division, behind many innovative drugs, there is a cro enterprise that provides R & D outsourcing services Therefore, a unique VIC Model (V refers to venture capital, I refers to intellectual property, and C refers to pharmaceutical R & D outsourcing services) is derived, which enables small and medium-sized innovative pharmaceutical enterprises to achieve a breakthrough from 0 to 1 without building their own laboratories and workshops at the initial stage of establishment With the development of cro industry, it has been moving towards a vertical integration platform to provide users with one-stop full process services For example, Wuxi Pharmaceutical Co., Ltd not only provides pre clinical CrO (drug R & D outsourcing) services, but also provides CMO / cdmo (drug production outsourcing) services The advantages of the whole industry chain make the drug companies more cohesive to the platform and have a broader development space According to the industry, with the maturity of the industry chain (CRO, cdmo) supporting the R & D of innovative drugs, the application of domestic innovative drugs projects ushered in a rapid growth period Data shows that in 2018, the number of domestic new drug ind (clinical trial application) applications climbed to 224, a year-on-year increase of 71%; at the same time, the number of domestic new drug NDA (listing license application) also increased rapidly: from 4 in 2015 to 45 in 2018 CDE data shows that as of November 2019, 73 domestic new drugs have applied for NDA.