THE INVESTOR

메뉴열기
March 29, 2024

BIOCND seeks approval for clinical trials of BTX

PUBLISHED : October 17, 2017 - 16:11

UPDATED : October 17, 2017 - 16:14

  • 본문폰트 작게
  • 본문폰트 크게
  • 페이스북
  • sms

[THE INVESTOR] BIOCND said on Oct. 16 it has sought approval from Korean drug authorities to conduct phase one clinical trials of its botulinum toxin (BTX) type A.

After getting the green light from the Ministry of Food and Drug Safety, it proposes to carry out early stage studies of BCD200 at Seoul National University Bundang Hospital. 



“We plan to complete the domestic approval procedures in the next two years,” a company official said.

At the same time, BIOCND plans to export the wrinkle treatment to countries that don’t require marketing authorization, including some Middle East and Southeast Asian countries, from 2018.

In July, the company completed construction of a plant dedicated to BTX products. The line has a capacity of 2.4 million vials per year, worth 100 billion won (US$88.30 million).

“We will accelerate the development of other biologic treatments by investing the revenue from commercialization of the toxin,” he said.

Founded in 2009, the company is currently developing three biosimilar candidates referencing blockbuster drugs -- including AbbVie‘s rheumatoid arthritis treatment Humira, Roche’s oncology therapy Avastin and Novartis’s eye drug Lucentis. None of the company’s biosimilar products have been marketed yet. Among them, its version of Avastin is in the most advanced stage of development, undergoing phase 3 clinical trials.

By Park Han-na (hnpark@heraldcorp.com)

  • 페이스북
  • sms
최상단으로
COPYRIGHT HERALD CORPORATION. ALL RIGHTS RESERVED.