Achievements

We are conducting Open Collaboration actively to improve our research capacities

Present ~ 2016

2024
Fexuclue’s cumulative sales surpassed KRW 100 billion (24.May)
Phase 3 trials of Atopic Dermatitis for Dogs treatment ‘DWP212525’ approved
Phase 3-3(VELOS-4) trials begin for dry eye syndrome treatment ‘HL036’ in the United States
2023
License-out of a first-in-class PRS inhibitor Bersiporocin in the Greater China region
Codevelopment of anti-cancer treatment
Exclusive licensing agreement for development and commercialization of Anti-Cancer Drug Generic DWJ108U in the U.S
2022
Phase 3 topline results announced for enavogliflozin, both for monotherapy and combination therapy with metformin
Investigational new drug (IND) Phase 2 study approved for ‘DWP708’ EGF cream
Joint research MOU with Pin Therapeutics for new drugs using protein lysis technology
Successful completion of Phase 3 trials for three-drug combination therapy of enavogliflozin, a new diabetes treatment
Fexuclue receives a Korea New Drug Development Award: A Grand Prize in the area of new drug development
Phase 3 trials for enavogliflozin approved in China
Concluded an MOU with the Seoul National University Hospital for the establishment of infrastructure for restorative medicine and clinical research on advanced biologics
New drug development agreement signed with KB Biomed to develop a modified treatment for osteoporosis using the technology for the oral administration of protein
Application for marketing approval of Fexuclue Tabelt, a new treatment for GERD, filed in the Philippines, Indonesia, Thailand and four countries in Central and South America
Approval of domestic new diabetes drug No. 36 Envlo
Phase 3 clinical trial of Nabota for chin reduction successfully carried out for the first time in the world
MOU for cooperation signed with DCGen for breast cancer symptom prediction kit
Marketing approval obtained in Saudi Arabia and Ukraine for Nabota
Declared the vision of ‘Global No.1 in Pharmaceutical Preparations by 2030’: Increased concentration on promising preparation technologies and open collaboration
Multinational Phase 2 trials begin for DWN12088, a new treatment for idiopathic pulmonary fibrosis
MOU signed with Cutis Bio for the development of environment-friendly, sustainable drug substances and their commercialization
Joint development agreement signed with Sky Therapeutics for development of percutaneously absorbed treatments based on solubilization technology
Stem cell CDMO agreement signed with Research Institute of Hearing Enhancement of Yonsei University and Affyxell therapeutics
Fexuclue Tablet, a new GERD treatment, is released
Daewoong Rosuvastatin Tablet 2.5mg Low-Volume obtains marketing approval
DWN12088 becomes the first new drug for idiopathic pulmonary fibrosis to be designated by FDA for the fast-track approval process
Obtained permit from the Ministry of Food and Drug Safety for an advanced cell product treatment facility and for regenerative medicine
Selected as an R&D project (development of cell treatment products) by the Korean Fund for Regenerative Medicine
Phase 1 trials completed for IVL3001, a continuously sustained long-term injection product for the treatment of alopecia areata, in Australia
Phase 1 trials in the United States for the new drug for autoimmune disease treatment approved by FDA
‘Fexuclue’ acquires gastritis as an additional indication after a month of its release
Phase 2 trials of botulinum toxin for cervical dystonia successfully completed in the United States
Nabota launched in Europe (product name in the UK is Nuceiva)
High-volume dexamethasone for oral administration approved in Korea for the first time, as “Dexa High Tablet"
Crezet a low volume, a combination drug (containing rosuvastatin) for hyperlipidemia, is released, expanding the lineup of treatment products for abnormal lipidemia
Fexuclue obtains marketing approval from the Food and Drug Administration of the Philippines
Approval of Vemliver Tab.
Selected as an R&D project by the Korea Drug Development Fund (Phase 2 clinical trials of DWN12088 for idiopathic pulmonary fibrosis)
2021
Received government funding for manufacturing equipment of COVID-19 treatment drug candidate DWRX2003
Contracts signed for the entry of Fexuprazan, a treatment for gastroesophageal reflux disease (GERD), in US, China and 6 Middle East markets
Obtained approval for advanced biologics manufacturing
V-Olet, an injection to reduce excessive jaw fat has been released
Joint R&D with OncoCross to discover new indications for enavogliflozin and DWN12088
Announcement of Phase 1 clinical trial results of DWN12088 in Australia, the first PRS-inhibiting pulmonary fibrosis treatment in the world
Pulmonary fibrosis treatment ‘DWN12088’ received additional designation from US FDA as a rare drug
Contract signed with D&D Pharmatek to develop orally administered peptide and protein preparations
Phase 3 topline results of botulinum toxin product Nabota announced in China
IVL3001, a continuously sustained long-term injection product for the treatment of alopecia areata, enters Phase 1 clinical trials in Australia
Fexuclue tablet, a new treatment for GERD, obtained marketing approval in Korea
Application filed in China for sales approval of Nabota
2020
Developed COVID-19 treatment and selected for a government-sponsored project
Daewoong Pharmaceutical’s Olostar was listed in the 2020 National R&D Excellence Top 100.
Novel diabetes drug Enavogliflozin designated for expedited review for the first time in Korea and conducted a phase 3 clinical trial
Registered as a bio-pharmaceutical accelerator, and sign an MOU with Gyeongsangnam-do, Gimhae, and Inje University
Established iN Therapeutics, a drug discovery company (spun off from Daewoong Pharmaceutical)
Selected as a company to be supported by the Ministry of Food and Drug Safety (MDFS) for Quality by Design (QbD)
Independently developed botulinum toxin Nabota obtained marketing authorization in Taiwan and Brazil
Obtained halal certification for Easyef Topical Solution and Epodion through Daewoong Infion, a joint venture in Indonesia
Concluded agreements with Mexico and Brazil to export the next-gen gastroesophageal reflux disease drug Fexuprazan
Established AffyXell Therapeutics, a joint venture specializing in cellular therapeutics, with the British biotech company Avacta
2019
Acquired the international standard ISO 9001 certification for a quality management system (QMS)
Received the Minister’s Award (Ministry of Science and ICT) as an institute of outstanding research note management
Completed phase-3 clinical trial on Fexuprazan, a next-generation drug for gastroesophageal reflux
Awarded by the government as an outstanding innovative pharmaceutical company
DWN12088, a new drug for pulmonary fibrosis, designated as an orphan drug by the USFDA
Urusa 300mg obtained indication for prevention of postgastrectomy cholelithiasis, being the first in the world
Officially launched Jeuveau, an internally developed botulinum toxin, in the US
Launched Olomax, a compound of three agents (olmesarta, rosuvastatin and amlopidine)
Phase-3 clinical trial result of Nabota in the US published in an SCI-grade international journal
DWN12088, a new drug for pulmonary fibrosis, selected for the inter-governmental support project
Internally developed botulinum toxin approved by USFDA, being the first in Asia
2018
Nabota obtained indication for eye wrinkles as the first botulinum toxin in Korea
DWP14012, a new drug for gastroesophageal reflux, selected for inter-governmental support project
2016
Completed construction of the Daewoong Bio Center
Meropenem Inj, an antibiotic, approved by the USFDA

2015 ~ 2011

2015
Olostar won the Technology Award for new drug development at the 16th Korea New Drug Award (KNDA)
Began joint development in the field of antibody through M&A with HanAll BioPharma
2014
Received a Prime Minister Citation in the science and technology category of the Korea New Growth Management Awards
Won the Technology Award for new drug development at the 15th Korea New Drug Award (KNDA)
Nabota selected as a World Class Product of Korea by the Ministry of Trade, Industry and Energy (MOTIE) and the Korea Trade-Investment Promotion Agency (KOTRA)
Released Nabota, a botulinum toxin, in Korea
Released Olostar, a new drug compound of olmesartan and rosuvastatin
2013
Won the 2013 Innovative Pharmaceutical Company Award
2012
Caretropin Pen won the 2011-2012 World Star Award
Selected for World Class 300, a global business development project
Selected as an Innovative Pharmaceutical Company
2011
Caretropin Inj. received the Minister’s Award
(Ministry of Knowledge Economy)

2010 ~ 2001

2008
Easyef acquired the International Nonproprietary Name (INN) certified by the World Health Organization (WHO) as the first in the world
2005
CoenzymeQ10 won the Minister’s Award (Ministry of Health and Welfare) at the Outstanding Technology Contest of the Health Industry Technologies Exposition Korea
CoenzymeQ10 won the Jang Yong-shil Award
Released Luphere, an anticancer agent
2003
Succeeded in developing CoenzymeQ10, being the second in the world
Easyef Topical Solution won second prize at the Korea New Drug Award
(Korea Drug Research Association: KNDA)
2002
Easyef Topical Solution awarded as one of 100 Outstanding Patented Products
2001
Released Easyef Topical Solution, Korea’s first new bio-pharmaceutical drug
Acquired the KT (Korea Good Technology) mark for Easyef

2000 ~ Founded

1997
Won Outstanding Achievement Award (Korean Intellectual Property Office) for the patented technology of Easyef
1987
Received the Iron Tower Order of Industrial Service Merit in the science and technology category on the 1st Science Day
Acquired the first genetic engineering patent in Korea
1983
Established Daewoong Central R&D Institute
1974
Established Subsidiary Pharmaceutical Research Center