台灣製藥產業以NRDO模式研發新藥的可行性分析

Abstract

新藥研發已成為一個高風險且昂貴的投資，而為因應這個問題，在近年來生技產業演化出了一種所謂NRDO（no research，development only）的模式開發新藥。在台灣也開始有公司採用這樣的模式做新藥開發。雖然NRDO模式在美國有許多成功的案例，但這並不表示同樣的模式在台灣也可成功，因為產業的參數是非常不同於美國的。 透過rNPV的模擬計算，顯示在絕大多數的情況下，因為台灣藥品市場的規模太小，投資於臨床試驗開發新藥不能得到合理的報酬。然而透過模擬計算，其結果顯示透過授權取得晚期的產品投資報酬率要高於早期的產品。而且對於晚期產品，如果能減少臨床試驗所需的受試者數目，將對rNPV有非常正面的影響，這是在早期產品中所沒有的情況。同時，對晚期產品的開發，若談判時能取的製造授權，也可顯著改善rNPV。 傳統的想法裡，當藥品的專利過期後，若能延長藥品的生命週期，能增加很多此藥品的價值。但是在rNPV的計算中顯示，延長生命週期，對藥品的rNPV值影響有限。 要解決台灣市場過小的先天性問題，可以在授權談判時爭取包括台灣以外如中國和韓國的銷售權。rNPV的模擬顯示，如果能爭取更大的地區銷售權，再執行臨床試驗開發時藥品時，不論採用平行開發或整合開發，都會得到更好的投資報酬率。 此外，從產業分析中我們也了解到，缺乏NRDO模型中生技製藥產業的互補者，如CRO或CMO等，是一項嚴重的問題，必須加以解決。政府應該提供更高的鼓勵誘因，同時制定更好的產業政策，建立產業相互關連的組織機構，完成生技製藥產業的軟硬體基礎建設，產業才能有機會上發展。

New drug development has become an expensive and high-risk investment. A new business model, NRDO (no research, development only), has evolved in recent years to address this problem. Biopharmaceutical industry in Taiwan has also started to adapt the NRDO model. While there have been numerous successful cases in US with this model, it may not guarantee the same success in Taiwan, because the economic parameters are very different locally. Through the simulation of risk-adjusted net present value (rNPV), the results indicate that in most of the cases, Taiwan market alone can not support the expected financial returns of the clinical research of NRDO model. However, the analysis also shows that in-licensing late stage products results in much better rNPV than early stage products. And for late stage products, reducing subject number in clinical trials can have big impact on rNPV, which is not so obvious for early stage products. When in-license late stage products, obtaining manufacturing rights can also improve rNPV greatly. Conventional wisdom suggests that extension of product life-cycle beyond the patent expiration can increase the product value significantly. However, our rNPV simulation shows a very different result. The product life-cycle extension has very limited impact on the rNPV. The in-licensing negotiation to expand the market territories can be a solution to the limited market size of Taiwan. Both parallel and integrated development of in-licensed products in Taiwan plus another country such as China or Korea, can give a much better return for the investment. Lack of capable industry complementors, such as CROs and CMOs, is a critical issue that need to be addressed for NRDO model. Government should give more incentives and create an executable policy to build up better infrastructure for the biopharmaceutical industry.