Information Systems Review (경영정보학연구)

The Korea Society of Management Information Systems (한국경영정보학회)
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The Information Effect of FDA Approval Announcements on Pharmaceutical and Bio-Health Companies' Stock Prices

FDA 승인 공시가 제약 및 바이오·헬스케어 기업의 주가에 미치는 정보효과

  • Yu Jeong Song (Sogang Business School, Sogang University) ;
  • Sang-Gun Lee (Sogang Business School, Sogang University) ;
  • So Ra Park (Department of Business, Chonnam National University)
  • 송유정 (서강대학교 경영대학) ;
  • 이상근 (서강대학교 경영대학) ;
  • 박소라 (전남대학교 경영학부)
  • Received : 2023.12.13
  • Accepted : 2024.02.09
  • Published : 2024.02.29
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Abstract

Korean pharmaceutical and bio-health companies began applying for FDA approval in 2000. However, drug companies in South Korea are not required to obtain FDA approval to market their products on the South Korean market, and the approval process is highly resource-intensive. This study utilizes event study methodology to examine the information effect of US FDA approval announcements on the stock prices of pharmaceutical and bio-health companies listed on South Korean stock markets. The study's results show that FDA approval announcements caused abnormal increases in corporate stock prices, indicating that these announcements have a transnational information effect on South Korean companies' value. Furthermore, the results show that the impact of FDA approval announcements on stock prices is greater for small companies than mid-sized and large companies and in bio and healthcare industries than in the traditional pharmaceutical industry. This impact is also more significant on the KOSDAQ (Korea Securities Dealers Automated Quotation) companies than the KOSPI (Korean Composite Stock Price Index) companies and after the expansion of stock price limits. These findings signal that the information effect is more significant when regulatory controls are weaker. The results also indicate that obtaining FDA approval brings above-normal returns for companies and that FDA application is a high-risk, high-return investment.

한국의 제약 및 바이오·헬스케어 기업들은 2000년대 초부터 FDA 승인을 신청하기 시작했다. 제약회사들은 국내 시장에서 제품을 판매하기 위해 의무적으로 FDA 승인을 받을 필요가 없으며, 승인 과정에 있어 많은 자원을 필요로 한다. 따라서 FDA 승인을 받기위한 투자는 합리적으로 보이지 않는다. 본 연구는 사건연구(event study) 방법론을 활용하여 유가증권 시장 및 코스닥 시장에 상장된 제약 및 바이오·헬스케어 기업들의 주가에 대한 FDA 승인 공시의 정보 효과를 분석하였다. 연구 분석결과에 따르면, FDA 승인 공시에 대한 정보효과가 한국 주식 시장에서 작동하여 해당 기업의 주가를 유의하게 상승시키는 것으로 나타났다. 이는 미국 FDA 승인이 한국 제약 및 바이오·헬스케어 기업의 가치를 제고시키는 효과가 있다는 것을 시사한다. 또한, 중견 및 대기업보다는 중소기업에서, 코스피 시장보다는 코스닥 시장에서, 주가의 가격제한폭이 좁을 때 보다는 확대된 이후에 주가에 정보효과가 더 크게 반영되어 나타났다. 그리고 전통적인 제약산업보다는 바이오·헬스케어 산업인 경우, FDA 승인 공시에 주가는 더 민감하게 반응하는 것을 알 수 있다. 이상의 결과를 토대로 FDA 승인을 얻는 것이 기업의 주가에 긍정적 영향을 미친다는 것을 알 수 있었으며, 국내 기업들의 FDA 승인 신청이 고위험을 감수하며 높은 수익을 노리는 합리적인 투자에 해당함을 제시한다.

Keywords

Acknowledgement

이 논문은 전남대학교 학술연구비 지원에 의하여 연구되었음(과제번호: 2023-0491).

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