Hanmi Pharm's LAPSTriple Agonist designated as an orphan drug by U.S. FDA
Hanmi Pharm's LAPSTriple Agonist designated as an orphan drug by U.S. FDA
  • Jung Jun-ho
  • 승인 2020.03.12 11:16
  • 댓글 0
이 기사를 공유합니다

The U.S. FDA has designated LAPSTriple Agonist (HM15211), which Hanmi Pharm is developing as a new innovative drug, as an orphan drug for treating PBC (Primary biliary cholangitis).

This is the second such case since the FDA designated LAPSTriple Agonist as an orphan drug for the treatment of primordial sclerotic bileitis on March 5. Accordingly, Hanmi Pharm has secured the potential for development of treatment for not only non-alcoholic fatty hepatitis but also various autoimmune liver diseases.

The FDA’s Orphan Drug Designation is a system that helps develop and permit treatments for rare and incurable diseases or life-threatening diseases.

Various benefits will be granted, including tax breaks, exemption of the cost of applying for permits, and exclusive rights for seven years to approve the marketing license for the first time among products of the same class.

Under the designation of the orphan drug, there have been a total of 10 cases in which Hanmi Pharm has received rare drug designation from the U.S. FDA and European EMA so far.

"We are doing a lot of research not only in metabolic and anti-cancer diseases, but also in rare incurable diseases, so we expect good results to continue," said Kwon Se-chang, CEO of Hanmi Pharm.

삭제한 댓글은 다시 복구할 수 없습니다.
그래도 삭제하시겠습니까?
댓글 0
계정을 선택하시면 로그인·계정인증을 통해
댓글을 남기실 수 있습니다.

  • #1206, 36-4 Yeouido-dong, Yeongdeungpo-gu, Seoul, Korea(Postal Code 07331)
  • 서울특별시 영등포구 여의도동 36-4 (국제금융로8길 34) / 오륜빌딩 1206호
  • URL: www.koreaittimes.com / m.koreaittimes.com. Editorial Div. 02-578-0434 / 010-2442-9446. Email: info@koreaittimes.com.
  • Publisher: Monica Younsoo Chung. Chief Editorial Writer: Kim Hyoung-joong. CEO: Lee Kap-soo. Editor: Jung Yeon-jin.
  • Juvenile Protection Manager: Yeon Choul-woong. IT Times Canada: Willow St. Vancouver BC, Canada / 070-7008-0005.
  • Copyright(C) Korea IT Times, Allrights reserved.