Research On The International Development Trend And Influencing Factors Of Chinese Innovative Drug Enterprises

Background: In 2015,when the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices",a lot of domestic pharmaceutical and biotech companies start rolling out its new drugs during this historical opportunity period.And some companies not only focus on Chinese patients,but also choose to expand their innovative tentacles overseas.At present,the number of Investigational New Drug(IND)applications that submit to overseas regulatory agencies such as FDA and EMA by domestic companies is still increasing by years.And some products developed abroad is progressing rapidly.Zebutinib,the innovative drug of Bei Gene,launched into the US market at the end of 2019,half a year earlier than it approved in China.But only a few researches pay attention to it due to the short time of this new trend appeared.Objective: Through the research on strategies for international products development by domestic innovative companies,this paper aims to understand the current situation of domestic innovative drug internationalization,to explore the effects of new drug internationalization strategies,and provide suggestions for corporate decision-making and related policy setting.Method: This paper collect the data of 180 innovative drug companies,including 90 companies developing clinical trials abroad and 90 companies not.All data in this research collected by public channels or interviews because of no existing database.By the use of Case-control study model,first,uses statistic method to describe the current status of domestic innovative companies and uses K-means cluster analysis to classify 180 samples.Secondly,by application of multi-factor logistic analysis method,explore the influence factors on drug international developed strategy.Third,find heterogeneous factors in the analysis such as business types or established time.Finally,combined with the analysis of the current situation,the influence factors of decision-making and the policies of industry,provide reasonable suggestion for the domestic innovative companies and products internationalization.Result: From descriptive research,it is found that international products development conducted by domestic companies shows a general upward trend in recent years。2015 to 2018 is the fastest growing stage,and then it enters a high stable period.In 2018,the number of new internationalized products reached a peak of 37.From 2019 to 2020,it also stay above 30.Biotech companies,accounting for 3/4 of the total,are the main contributors to this trend.And traditional transformation companies are also actively to internationalize.Most of these products focus on popular research areas such as cancers,anti-infection,nonalcoholic steatohepatitis(NASH),autoimmune diseases,Alzheimer’s disease and heart failure.More products are small molecular or antibody,but cutting-edge products such as cell therapy and antibody conjugate drugs(ADC)are also involved in.Through logistic regression studies,it is found that the background of R&D leader,the time of innovative drugs development,the source of innovative products,the novelty of product innovation,and orphan drug or not are the main factors influencing companies’ decision making.But the influencing factors are heterogeneous in terms of founder background,company type,R&D expenditures,indications,and whether they are listed on the capital market.The influencing factors of companies with different characteristics are different.Conclusion:R&D capability is the most important factor of decision making for international product development.Biotech companies have obvious advantages in this regard,laying an important foundation of domestic companies conducting international product in overseas markets.But local enterprises is lack of experience in international product development,and their resource cannot meet the late-stage clinical development.Developing drugs in popular area will aggravate this problem.Therefore,it is necessary to make reasonable policies and decision according to the trends in international products development and the characteristics of domestic enterprises,correcting the resources misallocation by enterprises and market,promoting cooperation between traditional pharmas and small biotech companies,increasing the efficient use of resource.It calls for differentiated policies targeting on different subgroups.