新藥研發過程與相關資訊揭露之研究

生技產業，尤其是新藥產業，具有高報酬、高風險、研發期長、知識密集的產業特性，因此極需要資本市場的支持。相較於歐、美新藥產業，國內仍在發展初期，規模尚小，產業總市值僅相當於歐美一個中型生技藥廠的市值。但相對地，生技產業目前市值遠大於產值的問題已讓該產業有股價泡沫化之疑慮。再者，目前國內投資人對新藥領域多不熟悉，往往只考慮題材而忽略評估新藥公司的競爭優勢。因此應降低新藥公司資訊不對稱性以重建資本市場的信心，本研究目的係分析個案台灣浩鼎公司核心藥物專案之研發過程與相關資訊揭露，以釐清個案爭議點之緣由，並與智擎生技比較，提出建議如下： 1.資訊揭露內容 (1)內部資訊 A.新藥公司之資訊揭露內容原則應具一致性。 B.針對臨床試驗設計及預計進度若有改變，應及時作揭露。 C.強化新藥公司的投資人關係部門（Investor Relations, IR）。 (2)外部資訊由證期局與TFDA合作資訊揭露，評估建立專家群資訊平台，同步資訊揭露於公開資訊觀測站之可行性。 2.資訊揭露時點 (1)內部資訊 A.研發流程訂入內部控制規範。 B.IPO過程讓會計師與承銷商盡責輔導有效性執行。 (2)外部資訊由證期局與TFDA合作資訊揭露，評估連結國際相關主管機關提供近期藥物核准上市情形。同步資訊揭露於公開資訊觀測站之可行性。 3.內部人 (1)依新藥個別專案揭示利益衝突。 (2)依新藥個別專案之利益衝突人採禁聲令。 (3)設計員工股權信託制度，將持股資訊透明化。

關鍵字

生技；新藥；研發過程；臨床試驗；雙盲；主要療效指標；利益衝突；資訊揭露

並列摘要

In biotech Industry, especially in new drug industry, it has high return, high risk, long development period, and is knowledge-intensive, therefore it highly needs for fund-raising from the capital market. Compared to US and Europe, the new drug companies in Taiwan are still in early stages and are relatively small in size. The total market size of Taiwan pharmaceutical industry is roughly equal to a medium-sized pharmaceutical companies in US or in Europe. But relatively much bigger market value of current biotech companies has increased the doubt of stock bubble in Taiwan. Moreover, domestic investors are not familiar with new drug companies, and often only evaluate new drug companies by subjects but ignore the company's competitive advantage. Therefore, the company should reduce gap in information asymmetry to rebuild investors’ confidence. This study was to analyze OBIpharma case and PharmaEngine case about the new drug’s R D process of the core project and information disclosure in order to clarify the cause of the case point of controversy, the recommendations are as follows: 1. For Detail Aspect (1) Inside information A. Information disclosure of new drug companies should be a principle of consistency. B. Clinical trial design and anticipated schedules which are subject to change over a period of time should be made to public. C. Strengthen the company's Investor Relations . (2) Outside information Evaluate the feasibility of establishing information disclosure principles and the expert peer platform and synchronize them on MOPS by the Securities and Futures Bureau in collaboration with TFDA. 2. For Timing Aspect (1)Inside information A. The internal control includes development process. B. During IPO process，CPA and Underwriters have the responsibilities to perform due diligence. (2)Outside information Evaluate the feasibility of providing the relevant international authorities links to recent cases of drugs approved for sale and synchronize them on MOPS by the Securities and Futures Bureau in collaboration with TFDA. 3. For Insider Aspect (1)Reveal a conflict of interest by individual projects. (2)Keep silence for relevant people of a conflict of interest. (3)Establish employee share’s trust fund, and hold information transparency.