Novartis, Roche, Pfizer Who has applied for the most clinical trials of top 10 pharmaceutical companies in China? Who withdraws the most?

For medical people, "5.20" should have a different color Who applies for the most clinical trials in China? Who completes the most? Who withdraws the most? Why? The answers are all in this article How did you spend the annual "5.20"? Have you been immersed in sweet words and can't extricate yourself? Have you got the gift you like? Have you spoken out the words "I love you" to your loved ones, your parents, lovers and children? For medical people, "5.20" should have a different color This year's 5.20 is the Fourteenth International clinical experiment day On May 20, 1947, the Scottish naval surgeon, Lind, conducted a clinical trial of scurvy, which is believed to have pioneered the clinical trial In commemoration of this historic event, the European clinical research foundation network, in collaboration with the United States and Canada, proposes to designate May 20 as the international clinical trial day every year May 20, 2005 became the first international clinical trial day As an important part of the new drug development process, the importance of drug clinical trials naturally need not be discussed Not only the most basic properties of drugs - effectiveness and safety ultimately need to be tested, but also the clinical trials provide the basis for doctors and patients to use new drugs correctly The indications, dosage, route of administration, dosage form and formula, individual use differences, contraindications, drug resistance, drug resistance and other influencing factors of drugs all depend on clinical trials to determine Information For pharmaceutical companies, the specific development of clinical trials, such as the success of patient recruitment, the cooperation of clinical experimental bases, and the ideal effect of clinical trials, directly determine whether their drugs can be successfully listed as expected On the day of international clinical trial day 5.20, we have made statistics on the overall situation of top 10 pharmaceutical companies in the world (ranking based on the top 50 global pharmaceutical companies of pharmaceutical managers in 2017) currently conducting clinical trials in China Among them, there are not only ongoing clinical trials, but also completed clinical trials In addition, the vast majority of enterprises have previously declared but later voluntarily suspended clinical trials for various reasons 1 declaration in China: Novartis is the absolute tycoon According to the annual ranking of top 50 global pharmaceutical enterprises by pharmaceutical executive of the United States, the top 10 global pharmaceutical enterprises in 2017 are Pfizer, Novartis, Roche, Merck, Sanofi, Johnson & Johnson, Gilead science, GlaxoSmithKline, Aberdeen and Amgen Because the ranking only ranks the global pharmaceutical companies' sales of prescription drugs in the last year, and does not include reference values such as market value and consumer goods business, it is closer to the real strength of pharmaceutical companies But it is also the top 10 pharmaceutical company, reflected in the clinical trial application in China, but its performance is far from the same In terms of quantity, the largest number of clinical trials declared in China is Novartis from Switzerland It can be retrieved on the drug clinical trial registration and information publicity platform Of all the available records, Novartis has applied for 83 clinical trials, 41 of which are in progress, 36 have been completed, and 6 are in active suspension Of the 41 ongoing clinical trials, 11 have been recruited Most of these projects are clinical phase III or post marketing phase IV, except for one which is still in clinical phase II, and all of them are international multi center clinical trials After Novartis, Roche Among all the records available, Roche has declared 68 clinical trials in total, and 54 are in progress Roche is the enterprise with the largest number of clinical trials in all top 10 pharmaceutical enterprises Among them, another large-scale target drug, patozumab, after trastuzumab (Herceptin), was also included Previously, Roche has submitted the listing application to CFDA, and obtained the qualification of priority review Currently, the drug has been in phase III clinical state, and it is also one of the relatively rapid clinical progress Pfizer came in third Although Pfizer and Novartis are at the top of the pharmaceutical manager rankings, there is a big gap between the number of clinical trials in China, whether they are ongoing or completed, and Novartis At present, there are 23 clinical trials in progress and 16 clinical trials have been completed In addition, it is understood that there are at least two heavy clinical trials in China in 2018 One is a phase III randomized open-ended parallel controlled multicenter study comparing the efficacy and safety of tacrolimus capsule and cyclophosphamide injection in the treatment of lupus nephritis Behind this clinical trial, there is a global market of up to $3 billion Another is a randomized, double-blind, phase III clinical study comparing the efficacy and safety of rituximab combined with lenalidomide (CC-5013) and rituximab combined with placebo in the treatment of relapsed / refractory inert lymphoma Further down, the number of clinical trials being conducted by pharmaceutical companies in China is relatively low Merck / Merck has 22 ongoing clinical trials, basically in line with Pfizer, while GSK has only 16 Sanofi, Aberdeen, Amgen, Gilead science and Johnson & Johnson are all under 10 Top 10 pharmaceutical companies' clinical trial application in China 2 the two major challenges must be noted that, except for a few enterprises, the vast majority of multinational pharmaceutical companies' clinical trial application in China has the situation of "active suspension" In this respect, Roche has the largest number, nine Of course, this is also related to the large number of them The second was Novartis and Merck, with six clinical trials suspended From the specific reasons, the lack of efficacy or risk-benefit ratio is not ideal is an important reason for most clinical trials to be suspended For example, the nine clinical trials of Roche's active suspension are all attributed to this kind of situation For example, aliglitazar, a drug used in patients with type 2 diabetes mellitus with acute coronary syndrome, was found to be ineffective in the test data, and combined with other safety signals, it was found that its overall risk benefit ratio was not ideal, so Roche took the initiative to suspend the clinical trial In fact, this is the normal situation in the research and development of new drugs The risks and difficulties of new drug research and development are well known In recent years, multinational pharmaceutical companies are also constantly adjusting or cutting their existing R & D pipeline, so as to focus on the more promising field of medicine For example, Pfizer has said that it will stop the discovery and research of Alzheimer's and Parkinson's disease treatment drugs, and GSK has officially closed its global research and Development Center for nervous system drugs in China On the other hand, the recruitment of patients in clinical trials is a big problem Although China is more and more included in the international multicenter clinical trials, the recruitment of patients is still a challenge For example, Novartis acz885, a drug for atherosclerosis, has a total planned enrollment of 10000 people, 140 people in China, but the actual enrollment of 10105 people, 126 people in China, does not meet the original enrollment plan As another clinical trial of bkm120 for the treatment of locally advanced or metastatic breast cancer, it has reached the third stage The planned target enrollment is 1060 in total and 150 in China, but the actual enrollment is 1130, but only 47 patients in China are enrolled, less than one third of the planned enrollment But in addition, there are some special cases of active suspension For example, Pfizer previously declared the bioequivalence test / bioavailability test of amlodipine besylate tablets (loxorubicin) for the treatment of hypertension and coronary heart disease, but on December 29, 2017, the product was publicized as the original reference preparation on CFDA website, so it was confirmed that the be test of generic drug consistency evaluation had been approved for exemption, and the test was automatically terminated 3 international multi center: according to the statistics of drug clinical trial registration and information publicity platform, as of May 20, 2018, 8396 clinical trials have been registered on the platform From the current situation, chemical drugs still occupy the absolute proportion of clinical trials, 69.8%, followed by biological products, 17.07%, Chinese medicine and natural drugs are the least, 13.12% In terms of the nature of clinical trials, the vast majority of clinical trials declared are still domestic trials, accounting for 91.06%, while international multicenter clinical trials only account for 8.94% But an inevitable trend is that in the future clinical trials, the proportion of biological products will gradually increase, and the proportion of international multi center clinical trials will continue to increase On the one hand, biological products have become an important part of multinational pharmaceutical companies and domestic innovative enterprises Whether PD1 / PD-L1 or car-t therapy is booming in the past two years, each round of new concepts has spawned a number of biopharmaceutical companies and triggered a new wave of clinical application With China's accession to the ICH, China has started to integrate with the international level in the pharmaceutical research and development system and the road of internationalization of registration More and more multinational companies pay more attention to the Chinese market, and no longer worry about the tedious approval procedures and long time At this level, it is only a necessity to bring China into the scope of international multicenter experiments.