Company
A global big biotech company
Navigating the Path of Challenges, Innovation, and Milestones.
History
2024
~ 1993
History
2024
~ 2021
- 2024
-
Joined hands with ProEn Therapeutics for radiopharmaceuticals
Became the first Korean pharmaceuticals company to receive the highest ESG rating of ‘AAA’ from MSCI
Presented phase 3 clinical trial results in Northeast Asia at AES
Sealed collaborative research agreement with KIRAMS
Eurofarma submitted NDA for cenobamate in Brazil
Announced roadmap for RPT business development
Signed high-quality radioisotope supply agreement with TerraPower
Sealed a licensing agreement with Full-Life Technologies to develop and commercialize 'FL-091' radiopharmaceutical compound
Cenobamate (XCOPRI®; ONTOZRY®) treated over 100,000 patients in the U.S., Europe, Israel, and Canada
Signed a licensing deal with Dong-A ST to commercialize cenobamate in 30 countries, including Korea
Cenobamate (XCOPRI®) launched in Canada by Paladin labs
- 2023
-
U.S. patent rights for cenobamate extended to 2032
Acquisition of SK Life Sciences Labs
Signed an MOU with Korea Institute of Radiological and Medical Sciences for R&D of radiopharmaceutical therapy
Forged a strategic alliance with Hikma to commercialize cenobamate and new drugs in MENA
Launched "Scientific Advisory Board" to grow as "Big Biotech"
Cenobamate (XCOPRI®) approved in Canada
Cenobamate (XCOPRI®) approved in Israel
Wearable devices win Red Dot Design Award
and iF Design AwardObtained IND approval for P3 trial of cenobamate
for PGTC adolescents in KoreaShowcased wearable devices at the 2023 CES
Submitted IND for P3 clinical trial of cenobamate
for PGTC adolescents in Korea
- 2022
-
Obtaining the approval of the investigational new drug application (IND) from the US FDA for SKL27969, an innovative target anti-cancer drug
Global phase 3 clinical trial for carisbamate with the US FDA
The first Korean company in the pharmaceutical and biotechnology industries to join PSCI
The first announcement of the "social value (SV)" creation results
Licensing out cenobamate to Israel
Licensing out cenobamate to Central and South America, celebrating its expansion into four continents
SKL27969, an innovative target anti-cancer drug, selected for the national new drug development project
The first Korean pharmaceutical company to win the CES 2023 Innovation Award
Winning the “100 Million Dollar Export Tower” award with the single innovative new drug
- 2021
-
Solriamfetol (SUNOSI®) launched in Canada by Jazz Pharmaceuticals
SKBP Sustainability Report released for ESG management
UK MHRA approved cenobamate
Cenobamate (ONTOZRY®) launched in Germany as part of Europe-wide commercial rollout by Angelini Pharma
European Commission approved cenobamate
EMA CHMP grants positive opinion for cenobamate
History
2020
~ 2012
- 2020
-
Ono Pharmaceutical acquired the rights to develop and commercialize cenobamate in Japan
IND approved for phase 3 clinical trial with cenobamate in Japan, China and Korea
SK Biopharmaceuticals IPO launched on the KOSPI
Cenobamate (XCOPRI®) launched in the US
European Commission approved solriamfetol
- 2019
-
EMA CHMP grants positive opinion for solriamfetol
Solriamfetol (SUNOSI®) launched in the US by Jazz Pharmaceuticals
FDA approved cenobamate as a treatment for partial-onset seizures in adults
Arvelle Therapeutics International (formerly Arvelle Therapeutics) acquires the rights to develop and commercialize cenobamate in Europe
FDA approved solriamfetol for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea
US IND activated for SKL24741
- 2018
-
SKL20540 selected as a project to be supported by the KDDF
Established 'Kinisi Therapeutics' with Glycyx Therapeutics.
Cenobamate, NDA submitted to the FDA
- 2017
-
Carisbamate received Orphan Drug Designation from the FDA
Solriamfetol, NDA submitted to the FDA
- 2016
-
US IND activated for SKL20540
- 2015
-
Spin-off of SK Biotek (active pharmaceutical ingredients and advanced intermediates business)
- 2014
-
Solriamfetol, Jazz Pharmaceuticals acquires the development and commercialization rights from Aerial BioPharma
- 2013
-
US IND activated for SKL-A4R
SKL-PSY, Strategic alliance with PKU Care Pharmaceutical
R&D Center & Shanghai Medicilon for development
and commercialization of the drug
- 2012
-
Cenobamate selected as a project to be supported by the Korea Drug Development Fund (KDDF)
Relenopride selected as a project to be supported by the KDDF
History
2011
~ 1993
- 2011
-
Establishment of SK Biopharmaceuticals
US IND activated for YKP-PD
SKL-AP2, Strategic alliance with Shanghai Medicilon for development and commercialization of the drug
Solriamfetol, Strategic alliance with Aerial BioPharma for development and commercialization of the drug
- 2009
-
US IND activated for relenopride
- 2005
-
US IND activated for cenobamate
- 1998
-
US IND activated for carisbamate
- 1996
-
US IND activated for solriamfetol (first Korean company to successfully activate a US IND)
- 1993
-
Initiated R&D for new drug development