BOOKMARK
  • Korean|
  • Chinese|
  • Japanese|
  • Vietnamese
본문내용 바로가기

Aju Business Daily

SEARCH
  • ECONOMY
  • ENTERTAINMENT
  • IT
  • South Korea
  • North Korea
  • WORLD
  • SPORTS
  • LIFESTYLE
  • AUTO MOTIVE
  • OPINION
  • PEOPLE
  • MILITARY
Home > Business > article

Samsung Bioepis allowed to go ahead with clinical trial in China for biosimilar candidate

Lim Chang-won Reporter(cwlim34@ajunews.com) | Posted : January 10, 2020, 10:56 | Updated : January 10, 2020, 10:56
  • 트위터
  • 페이스북
  • 웨이보

[Courtesy of Samsung Bioepis]

SEOUL -- Samsung Bioepis, a U.S. and South Korean biopharmaceutical joint venture company, has won Chinese approval to go ahead with Phase 3 clinical trial for SB12, a biosimilar candidate referencing Soliris (Eculizumab), a high-priced drug developed by Alexion Pharmaceuticals of the United States.

The China National Medical Products Administration (NMPA), a state regulatory body, has approved a Phase 3 clinical study for SB12, referred to as AMT904 in China, Samsung Bioepis said in a statement on Friday.

SB12 was developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare disease in which the destruction of red blood cells leads to red discoloration of the urine. Soliris has been used to treat the rare disorders atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria. The average cost is estimated at around 500 million won ($431,035) for a one-year supply.

The approved clinical trial in China is part of Samsung Bioepis' ongoing global Phase 3 trial that began in August 2019. AffaMed Therapeutics, a biopharmaceutical company founded by the Chinese healthcare private equity firm CBC Group, has received exclusive rights to commercialize the treatment in China and Singapore.

"The clinical collaboration with AffaMed furthers Samsung Bioepis' goal to innovate access to life-changing medicines for patients in need," Samsung Bioepis' clinical operation team vice president Hong Il-sun was quoted as saying.

"This is AffaMed’s second biosimilar candidate to receive CTA approval within one-year of founding, accelerating its goal of providing innovative medicines to Chinese patients improving accessibility," said AffaMed CEO Nathan Pang.

Samsung Bioepsis, a joint venture between Biogen, a U.S.-based pharmaceutical company, and Samsung BioLogics, a bio company affiliated with South Korea's largest Samsung Group, has been known for Imraldi, an adalimumab biosimilar referencing Humira. Trastuzumab, sold under the brand name Herceptin, is a monoclonal antibody used to treat breast cancer developed by Swiss pharmaceutical giant Roche.

Samsung Bioepis has won U.S. approval to sell Ontruzant, a cancer-treating biosimilar referencing Herceptin. In 2019, the company won U.S. approval to sell its biosimilar referencing Enbrel (etanercept), one of the best-selling pharmaceutical products, that treats chronic diseases, including moderate to severe rheumatoid arthritis.

  • Lim Chang-won Reporter
  • email : cwlim34@ajunews.com
© Aju Business Daily & www.ajunews.com Copyright: All materials on this site may not be reproduced, distributed, transmitted, displayed, published or broadcast without the authorization from the Aju News Corporation.
  • twitter
  • facebook
  • weibo
  • link copy
  • LIST
  • TOP

Related news

  • .Samsung Bioepis demonstrates efficacy of first biosimilar for eye disease treatment.
    Samsung Bioepis demonstrates efficacy of first biosimilar fo…
  • .Prosecutors raid stock operators office in probe into Samsungs biosimilar arm.
    Prosecutors raid stock operator's office in probe into Samsu…
  • .Samsung Bioepis wins U.S. approval to sell cancer-treating biosimilar .
    Samsung Bioepis wins U.S. approval to sell cancer-treating b…
  • .Samsung Bioepis forges licensing deal with Chinese private equity firm .
    Samsung Bioepis forges licensing deal with Chinese private e…
  • .Court suspends execution of action against Samsung Biologics.
    Court suspends execution of action against Samsung Biologics

Real Time Photo News

  • .BTS agency posts record earnings in 2020 on brisk online activities and album sales .

    BTS agency posts record earnings in 2020 on brisk online activities and album sales

  • .[FOCUS] BTS agency leagues with Universal Music to launch new K-pop band in US music scene.

    [FOCUS] BTS agency leagues with Universal Music to launch new K-pop band in US music scene

  • .CJ ENM aims to become major visual content producer thru partnership with Epic Games .

    CJ ENM aims to become major visual content producer thru partnership with Epic Games

  • .​Solo singer Sunmi to come back with new album Tail.

    ​Solo singer Sunmi to come back with new album 'Tail'

  • .Big Hits live-streaming joint venture gains reinforcements from Universal Music, YG.

    Big Hit's live-streaming joint venture gains reinforcements from Universal Music, YG

Latest News

more+

  • Prime Minister Chung stresses importance of 'borderless communication channel' to minimize informati…
  • State hospital succeeds in inserting wireless pacemakers into hearts of bradyarrhythmia patients
  • LG Electronics' joint venture with Canada's Magna awaits approval by shareholders in March
  • Sajo Seafood to launch raw tuna menu delivery service
  • Researchers find new roundworm species near Dokdo
Aju Business Daily
  • ABOUT US
  • CONTACT US
  • PRIVACY STATEMENT
  • Copyright Policy

Address : Aju News Corporation LEEMA Building, 11th floor, 42, Jong-ro 1-gil, Jongno-gu, Seoul.    Mail : swatchsjp@ajunews.com

Copyright ⓒ 2016 By Ajunews Corporation, All Rights Reserved.

Mobile view