從公司內外部資源與技術授權探討台灣生技公司新藥開發策略─以個案公司為例

Abstract

新藥開發為需投入大量的人力、資金及時間的高風險產業，又藥品受高度法規管制且開發方向應與臨床需求相配合。然而台灣生技公司多屬中小企業規模，大都不能獨立完成從藥物開發到產品上市的整個新藥開發流程，故如何尋求適當的研發標的、加速研發的進程及提高成功率是台灣生技公司非常重要的課題。 改良式新藥相比於全新藥來說，可利用先前上市藥品之安全性及有效性資料，大幅度節省研發經費及縮短研發時間；各國政府祭出優利優惠政策支持罕藥開發，且臨床試驗規模較小，核准率較高；生技新藥公司為尋求新案源或是降低後期研發失敗風險，多選擇技術授權模式，找尋合作夥伴共同開發新藥，以期降低公司營運風險。 本研究以一家台灣生技新藥公司為例，分析該個案公司如何應用公司內外部資源與技術授權進行新藥開發。經研究發現，個案公司擁有優秀的研發能力及完整的專利佈局，並運用開放式創新尋求外部資源，且以改良式新藥及罕病罕藥為利基市場進行技術授權，使得新藥上市時程加速，並能切入全球醫藥產業鏈，以期對人類社會有所貢獻。

It is high-risk to develop new drug in pharmaceutical industry that requires a lot of manpower, capital, and time. Besides, drug development is highly controlled by regulation and the direction should be aligned with unmet medical needs. However, most of biotech companies in Taiwan are small and medium-sized enterprises and cannot complete the whole new drug development process through drug discovery to market. Therefore, critical points to Taiwan biotech companies are how to find an appropriate topic, accelerate the development process and increase the success rate. Compared to the new chemical entity, 505(b)(2) can apply safety and efficacy data based on previous launched drugs, and save lots of R&D expenditure and time. Governments provide preferential policy to encourage orphan drug development, and scale and approval rate of orphan drugs are smaller and higher. In order to get new projects or lower the risk of failure in the latter phase, biotech companies prefer using technology licensing to find partners for co-development to reduce operating risks. In this study, one Taiwan biotech company is taken as an example to describe how to use internal and external resources and technology licensing to develop new drug. The study shows that the case company has good R&D capability, comprehensive patent portfolios, and applies open innovation to survey external resources, and uses strategies of 505(b)(2) and rare disease/orphan drug as niche topics to facilitate technology licensing. These strategies can speed up the product lunch and get involved in the global pharmaceutical industry chain and contribute to the human beings.