선바이오(주)

2025

• 05 US patent (#12,295,991) granted, titled “Hemoglobin derivative co-conjugated with fatty acid-linked PEG and alkoxy PEG as a blood substitute”, covering a composition intended for use as a blood substitute.
• 04 SunBio GMP Manufacturing Facilities moved to a new location at 129 Eunbong-ro, Namdong-gu, Incheon-si, South Korea.
• 03 SBX (a blood substitute candidate) preclinical toxicity study completed.

2024

• 09 SunBio Headquarter, Office, and Laboratory, moved to a new location at 129 Eunbong-ro, Namdong-gu, Incheon-si, South Korea.
• 05 At 2024 AADOCR conference, the clinical trial results of MucoPEG (xerostomia treatment) were presented.
• 05 Australian patent (#2022211852) granted, titled “Oral rinse compositions for alleviating xerostomia comprising polyethylene glycol derivatives”, covering a composition intended for use as MucoPEG (xerostomia treatment).
• 04 Pelgraz (PEG-filgrastim biosimilar) voted as Best Value Biologic Medicine in Ireland.
• 04 US patent (#11,952,461) granted, titled "Siloxy Polyethylene Glycol and Derivatives Thereof", covering a composition as novel PEG derivative.
• 03 Japanese patent (#7,454,880) granted, titled “Oral rinse compositions for alleviating xerostomia comprising polyethylene glycol derivatives", covering a composition intended for use as MucoPEG (xerostomia treatment).

2023

• 06 At 2023 BIO conference, the clinical trial results of MucoPEG (xerostomia treatment) were presented.
• 06 Research to develop PEG-based solid electrolytes for lithium ion battery initiated.
• 03 Construction started for new buildings for offices, laboratories and GMP manufacturing facilities, located at 129 Eunbong-ro, Namdong-gu, Incheon-si, South Korea.

2022

• 10 Listed on Korean Stock Exchange (KOSDAQ).
• 07 A US clinical trial of MucoPEG was conducted at two US medical institutions.

2021

• 11 Pelgraz (PEG-filgrastim biosimilar) approved in Mexico.
• 05 Started to supply Evonik of Germany with a PEG product, which is a constituent of LNP (Lipid Nanoparticle) used in the preparation of COVID-19 vaccine.
• 01 US patent (#10,882,954 B2) granted, titled “Tertiary alkoxy polyethylene glycol and derivatives thereof” covering a composition for a novel group of PEG derivatives.

2019

• 11 MucoPEG approved by US FDA as a medical device to treat dry mouth.
• 08 Pelgraz (a PEG-filgrastim biosimilar) approved in Australia.

2018

• 10 Pelgraz (a PEG-filgrastim biosimilar) marketing started in EU.
• 09 Pelgraz (a PEG-filgrastim biosimilar) approved by EU EMA.
• 04 Lapelga (a PEG-filgrastim biosimilar) approved in Canada.
• 02 EU EMA QP (qualifying person) audited manufacturing facilities and quality system of PEG products.

2017

• 11 Completed the preclinical studies of MucoPEG.

2016

• 10 Started the preclinical studies of SynoGel (knee joint viscosupplement).
• 07 Korean patent (#10-1637883) granted, titled “Polyethylene glycol hydrogel injection” covering a composition for a knee joint viscosupplement.
• 06 Filed a PCT patent application for SynoGel.
• 04 Started the preclinical studies of MucoPEG.
• 03 Relocated to new offices, laboratories, and GMP manufacturing facilities at 95 Sanbon-ro, Gunpo-si, South Korea.

2015

• 09 Korean patent application filed for SynoGel.
• 06 Korean patent (#10-1526258) granted, titled “Mouthwashes and pharmaceutical compositions comprising polyethylene glycol derivatives for preventing, treating, improving xerostomia" covering a composition for use as a dry mouth treatment.

2014

• 07 PEG-interferon (hepatitis C treatment) approved in India.
• 06 PEG-filgrastim clinical trials completed in the US.
• 04 PEG-filgrastim clinical trials completed in EU.

2013

• 05 Korean patent application filed for MucoPEG.

2008

• 10 Korean patent (#10-0862651) granted, titled “Hair treatment composition, hair treatment agent and method for treating hair by using the same”.

2007

• 09 NEUPEG (a PEG-filgrastim biosimilar) approved in India, marketing started.
• 05 US patent (#7,217,845) granted, titled “Bifunctional polyethylene glycol derivatives” covering a composition intended for use as a pegylation agent for PEG-biopharmaceuticals.
• 01 Korean patent (#10-0671935) granted, titled “Hair coating composition comprising polyethylene glycol derivatives as an effective ingredient”

2006

• 09 Korean patent (10-0631855) granted, titled “Novel Y-PEG Derivatives and the preparation method thereof”
• 05 US patent (#7,041,855) granted, titled “Monofunctional polyethylene glycol aldehydes” covering a composition intended for use as a pegylation agent for PEG-biopharmaceuticals.
• 04 Supply and technology transfer agreement signed with Cartilix of USA.
• 02 Korean patent (10-0551096) granted, titled “Novel Y-PEG Derivatives and the preparation method thereof”

2005

• 11 Supply and technology transfer agreement signed with Cytimmune Sciences of USA.
• 10 Supply and technology transfer agreement signed with BioSite (later Alere) of USA.
• 10 US patent (#6,956,135) granted, titled “Monofunctional polyethylene glycol aldehydes" covering a composition intended for use as a pegylation agent for PEG-biopharmaceuticals.
• 08 Korean patent (#10-0512483) granted, titled “Novel preparation method of PEG-maleimide PEG derivatives”
• 08 Korean patent (#10-0511749) granted, titled “Pegylated interferon-beta, and chemically modified conjugates thereof”
• 07 US patent (#6,916,962) granted, titled “Monofunctional polyethylene glycol aldehydes" covering a composition intended for use as a pegylation agent for PEG-biopharmaceuticals.
• 04 Korean patent (#10-0488351) granted, titled “Novel polyethylene glycol- propionaldehyde derivatives” covering a composition intended for use as a pegylation agent for PEG-biopharmaceuticals.
• 03 Korean patent (#10-0480432) granted, titled “Conjugates of granulocyte -colony stimulating factor and polyethylene glycol derivatives".
• 03 Korean patent (#10-0480430) granted, titled “Conjugates of Interferon-beta and polyethylene glycol derivatives”
• 03 Korean patent (#10-0480429) granted, titled “Conjugates of Interferon-alpha and polyethylene glycol derivatives”.
• 03 Korean patent (#10-0480423) granted, titled “Conjugates of erythropoietin and polyethylene glycol derivatives”.
• 02 US patent (#6,858,736) granted, titled “Hexa-arm polyethylene glycol and its derivatives and the methods of preparation thereof “.

2004

• 12 US patent (#6,828,401) granted, titled “Preparation method of peg-maleimide derivatives”.
• 11 Korean patent (#10-0459105) granted, titled “Pegylated interferon-alpha 2a and 2b, and conjugate with PEG derivatives thereof”
• 09 Korean patent (#10-0451308) granted, titled “A virus removal process in the purification of biologically active molecules”
• 08 Korean patent (#10-0444944) granted titled “Polyethylene glycol hydrogel for bioadhesive”.
• 06 Licensing and technology transfer agreement signed with Serum Institute of India for the manufacturing process of PEG-filgrastim, PEG-interferon, and PEG-EPO.

2003

• 11 Licensing and technology transfer agreement signed with Intas Pharmaceuticals of India for the manufacturing process of PEG-filgrastim and PEG-interferon.

2000

• 10 Development of biosimilars, PEG-filgrastim, PEG-interferon, and PEG-EPO, started.
• 09 Moved to a new location at 980-5 Kwanyang-dong, Dongan-gu, Anyang-si, South Korea.

1999

• 05 Registered as a venture company in South Korea.

1998

• 08 SunBio Inc. R&D Center established.
• 06 Started manufacturing, marketing and distribution of PEG products.

1997

• 06 SunBio, Inc. founded in Seoul, South Korea.