Impact of accelerated review policy on portfolio planning of vaccine companies.

BACKGROUND

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.

AIMS AND METHODS

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.

RESULTS

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.

CONCLUSION

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.