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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 Award

Obtained IND approval for P3 trial of cenobamate
for PGTC adolescents in Korea

Showcased 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