Evaluation Practice of Overseas New Drug Launches in China Based on Data and Knowledge Calculation

Jing Wang, Jianjun Zhang and Han Wang

Chapter 71 in Internet Finance and Digital Economy:Advances in Digital Economy and Data Analysis Technology, 2023, pp 939-952 from World Scientific Publishing Co. Pte. Ltd.

Abstract: Buyers of global drugs must pay big licensing fees. As the race is different, at least before the drug launch in China buyers should ensure the effectiveness and safety of drugs, and what needs to be done is at least four phases of the clinical trial. If there is insufficient overseas clinical trial data, NMPA in China also needs RCT results or validation of drug safety issues of clinical studies. If a large amount of authorization fees is spent in the early stage and the sales volume is not good after it is listed in China, it may be a failed license. Therefore, it is necessary to consult before buying and help buyers make decisions based on data, policies, and expert opinions. We analyze the domain of the disease, learn from epidemic diagnosis to treatment and prognosis of process and data, production for the domestic top clinical experts, statistics, registration experts, policy adviser to the questionnaire, interview, and then summarize the research results. According to the expert opinion, we can give advice on whether it can be licensed in China successfully. It is recommended that the original factory prepare the materials needed for registration in China as soon as possible, and explain the controversial aspects of the original factory’s registration trial design. The overall recommendation is: if the original manufacturer can provide all the overseas materials required for the drug to be registered in China, the explanation of the controversial aspects of the registration trial can be accepted by Chinese experts, and the domestic manufacturer has the money to do both the RWS and the small RCT, the drug is still worth licensing in. We use NLP and knowledge graphs to calculate the commercial decision. Before developing a program we use data and knowledge to evaluate every KOL to select suitable ones. Data was collected from Pubmed and the introduction from portals of hospitals.

Keywords: Internet Economy; Online Finance; Financial Engineering; Big Data; Blockchain; Supply Chain; E-commerce (search for similar items in EconPapers)
JEL-codes: G2 O33 (search for similar items in EconPapers)
Date: 2023
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