What is the impact of the epidemic on the drug clinical research of multinational drug companies in China?

Wen Mu Mu Mu China's market is one of the core growth points of innovative drug business of multinational pharmaceutical companies in recent years, and more and more multinational pharmaceutical companies have incorporated China into the global drug clinical research, and China has gradually moved closer to the global new drug market center With the outbreak of novel coronavirus pneumonia (COVID-19) in China recently, the research projects of multinational pharmaceutical companies in China have also been affected How much of the impact is there? This paper attempts to analyze the regional distribution of clinical trials in China and the third phase clinical trials in China, hoping to get the answer According to biocontry's survey on the distribution of clinical trial sites of multinational pharmaceutical companies in China, as of February 4, the sites of clinical trials listed as recruitment or active by multinational pharmaceutical companies on clinicaltrials.gov were mainly in Beijing (827), Shanghai (664) and Guangdong (560), followed by Jiangsu (473), Zhejiang (450), Sichuan (318), etc There are 284 research projects in Hubei Province Figure 1: distribution of clinical trial sites of multinational pharmaceutical companies in China Note: as of February 4, it was listed as the place of recruitment or active interventional clinical trials on clinicaltrials.gov (the same trial conducted in multiple places in one province only once in that province) Source: who, clinicaltrials.gov, biocentry As of February 18, China's covid-19 epidemic is mainly concentrated in Hubei, and the provinces with relatively large numbers of epidemic cases outside Hubei are Guangdong, Henan, Zhejiang, Anhui, Jiangxi, etc Comparing the regional distribution of research institutions of multinational pharmaceutical enterprises in China and the distribution of covid-19 epidemic area, we can find that there is a certain degree of overlap between them, such as Guangdong and Zhejiang, which are not only the places with more clinical trials, but also the provinces with the highest number of epidemic cases Moreover, the unbalanced distribution of research institutions reflects the differences of medical resources in different regions of China Meanwhile, in order to alleviate the medical burden of the severely affected areas, major hospitals across the country are sending personnel to support Hubei In addition, the admission of ordinary patients during the epidemic is limited, so many experimental sites of multinational pharmaceutical enterprises will be negatively affected Figure 2: epidemic map of covid-19 Source: Dr lilac In Wuhan, Hubei Province, where the epidemic is most serious, at least 18 multinational pharmaceutical companies have conducted clinical trials in Wuhan, according to clinical trials.gov In terms of the number of trials, AstraZeneca, Albright and Lilly conducted the largest number of intervention trials in Wuhan, 21, 18 and 15 respectively; in terms of the proportion of the number of trials in China by each enterprise in the total number of global trials, Roche, Lilly, Bayer and Weicai ranked in the top three respectively, of which the first two accounted for 33%, 9% and the latter two accounted for 8% Figure 3: clinical trials conducted by multinational pharmaceutical companies in Wuhan and the proportion of the number of trials in China to the total number of trials in the world Source: clinicaltrials.gov (Note: Roche includes Genentech, Bristol Myers Squibb includes celgene) In the short term, the completion of phase III clinical trials has a great impact on the development and performance of pharmaceutical companies Therefore, let's take a look at the phase III clinical trials of multinational pharmaceutical companies in China According to clinical trials.gov, 224 global phase III clinical studies conducted by at least 20 multinational pharmaceutical companies in China have not yet reached the estimated completion date However, the ongoing outbreak of covid-19 in China will delay these projects As for whether the delay of the trial in China will affect the review and approval plans of these enterprises in other countries, and how much the impact is, it depends on how much data of each study comes from the trial in China, that is, the dependence of the trial on the Chinese clinical research base Through the analysis of the location of the test points in the clinical trials of various enterprises, we can determine the proportion of them in the Chinese clinical research base If the number of research sites in China is relatively small, it has little impact on the application plans of the enterprise in other countries; and vice versa The following analysis is based on an average of 30% of China's clinical research bases as the critical value If it is lower than 30%, it will not affect the evaluation plan of the research project in other countries, and if it is higher than 30%, it may cause negative impact According to statistics, 4 of the above 20 pharmaceutical enterprises account for more than 30% of China's clinical research bases on average, which are respectively Amgen, Novo Nordisk, Astaire and Takeda It is expected that the phase III clinical research projects of these 4 enterprises will be greatly impacted by the covid-19 epidemic in China Among them, Amgen's Chinese clinical research base accounts for the largest proportion on average, accounting for 39.4% Figure 4: proportion of some multinational pharmaceutical companies in China's clinical research bases Source: clinicaltrials.gov, Zhongkang Industrial Capital Research Center The following statistics show the phase III clinical trials carried out in China by 9 multinational pharmaceutical companies Among them, Sanofi and mosadong have at least five trials, Roche has four, Pfizer, Novartis and Lilly have several phase III clinical research projects only carried out in China Among them, Sanofi for atopic dermatitis drug dupixent dupilumab, 9-valent HPV vaccine of mosadong, basilar insulin glargine of Lilly for type II diabetes, and entyvio vedolizumab of Takeda for Crohn's disease are all planned to complete the trial in nearly three months, but no patients have been recruited at present Figure 5: the third phase of development of some multinational pharmaceutical enterprises in China Source: clinicaltrials.gov, Zhongkang Industrial Capital Research Center In addition, there are a number of phase III clinical trials planned for the first quarter of 2020 in China only For example, Johnson & Johnson plans to carry out the Stella ustekinumab test in early March, and its indication is systemic lupus erythematosus Stellara is a core product of Johnson & Johnson's entry into the field of autoimmune diseases In 2019, the drug generated $6.361 billion in sales, an increase of 23.4% over 2018 In addition, according to top product forecasts for 2020 published in nature, a top international journal, stelara's sales volume in 2020 is expected to reach 7.241 billion US dollars with the continuous increase of indications and the continuous expansion and penetration of the market, ranking 7th in the top 10 best selling drugs in 2020 However, given the impact of the covid-19 outbreak, these plans are likely to be delayed Figure 6: clinical trials planned by some multinational pharmaceutical companies in the first quarter of 2020 Source: clinicaltrials.gov, Zhongkang Industrial Capital Research Center Conclusion: there is a certain degree of overlap between the regional distribution of research institutions of multinational pharmaceutical enterprises in China and the distribution of covid-19 epidemic area, so many experimental sites of multinational pharmaceutical enterprises in China will be affected by the epidemic and unable to carry out research projects In Wuhan, which is the most severely affected area, AstraZeneca, Aberdeen and Lilly are expected to have the largest number of clinical trials From the perspective of short-term impact, it is expected that several phase III clinical trial drugs planned to be completed by Sanofi, MSD, Roche and other pharmaceutical companies in 2020 or 2021 will extend the R & D time, and the corresponding time to market may be months later than the original plan.