Liu Guicui, Huang Zhe
School of Business Administration, Shenyang Pharmaceutical University, Shenyang, China.
Drug Regulatory Research Base of NMPA - Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang, China.
Front Public Health. 2024 Dec 9;12:1339141. doi: 10.3389/fpubh.2024.1339141. eCollection 2024.
With the introduction of the accelerated drug review policy in China, the clinical research and development time and the review and approval time of drugs have been shortened accordingly. Especially under the influence of the COVID-19 pandemic, the vaccine formulations released through the accelerated review policy are springing up, and the question of how the accelerated review policy affects the investment portfolio of vaccine enterprises has also attracted more and more attention.
The article uses mixed-integer linear programming to develop a new model on portfolio planning for vaccine companies based on the accelerated review policy context. The model is constructed using the Gurobi extension class of .NET, and the investment decision is made and simulated by the Gurobi solver to investigate the portfolio planning decision of a vaccine company maximizing the net present value of its vaccine production portfolio with the increase of available capital over a 20-year time horizon.
The NPV under the accelerated review policy is significantly higher than the net present value under the standard review policy when the available capital exceeds RMB 900 million. And the difference between the two of them peaks at RMB 1.87 billion when the available capital is RMB 1.9 billion; break-even occurs about 1.3 years earlier in the accelerated review policy than in the standard review; and when the available capital is the same, firms in the accelerated review policy choose to produce four products earlier and make the decision to invest in facility construction earlier; scenarios in the accelerated review policy are not as sensitive to changes in model parameters as they are in the standard review.
The accelerated review policy is effective in providing incentives for commercialisation. The results of this study will provide an effective reference for vaccine companies to make scientific portfolio planning under the accelerated review policy.
随着中国加速药物审评政策的出台，药物的临床研发时间和审评审批时间相应缩短。特别是在新冠疫情的影响下，通过加速审评政策获批的疫苗制剂如雨后春笋般涌现，加速审评政策如何影响疫苗企业的投资组合问题也越来越受到关注。
本文运用混合整数线性规划，在加速审评政策背景下，为疫苗企业开发了一个新的投资组合规划模型。该模型使用.NET的Gurobi扩展类构建，并通过Gurobi求解器进行投资决策和模拟，以研究一家疫苗企业在20年时间跨度内随着可用资金增加最大化其疫苗生产投资组合净现值的投资组合规划决策。
当可用资金超过9亿元人民币时，加速审评政策下的净现值显著高于标准审评政策下的净现值。当可用资金为19亿元人民币时，两者差值达到峰值18.7亿元人民币；加速审评政策下的收支平衡点比标准审评政策大约提前1.3年出现；在可用资金相同的情况下，加速审评政策下的企业更早选择生产四种产品，并更早做出投资设施建设的决策；加速审评政策下的情景对模型参数变化的敏感度不如标准审评政策下的情景。
加速审评政策在为商业化提供激励方面是有效的。本研究结果将为疫苗企业在加速审评政策下进行科学的投资组合规划提供有效参考。
