Achievements
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
