Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dong-A ST Secures European Approval for Stelara Biosimilar IMULDOSA
Details : Imuldosa (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23. It is approved for treating plaque psoriasis, psoriatic arthritis and crohn's diseases.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
December 19, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA®
Details : Imuldosa (ustekinumab), is an approved IL-12/IL-23 inhibitor is given once in 12 weeks SC and IV for the treatment of moderate to severe plaque psoriasis in patients with 6 years or older.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
November 10, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CHMP Recommends the Approval of Dong-A ST’s IMULDOSA, a Biosimilar to Stelara®
Details : Imuldosa (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
October 21, 2024
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar
Details : DMB-3115 (ustekinumab) is a proposed biosimilar to Stelara being used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
July 17, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Study Phase : Phase III
Sponsor : Intas Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III
Details : DMB-3115 (ustekinumab) and Stelara demonstrated therapeutic equivalence when looking at percent change from baseline in PASI (Psoriasis Area and Severity Index) at Week 8 and Week 12.
Product Name : Imuldosa
Product Type : Antibody
Upfront Cash : Inapplicable
January 17, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Sponsor : Intas Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Darbepoetin Alpha
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Polifarma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Dong-A ST Signs License-out Deal with Polifarma of Türkiye for NESP® Biosimilar DA-3880
Details : According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 (darbepoetin alfa). DA-3880 is an ARANESP/NESP biosimilar for the treatment of anemic patients with chronic renal failure.
Product Name : DA-3880
Product Type : Protein
Upfront Cash : Undisclosed
September 11, 2022
Lead Product(s) : Darbepoetin Alpha
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Polifarma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : DA-1241
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : NeuroBo Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the license agreement, NeuroBo has obtained an exclusive license to develop and commercialize DA-1241 (a novel GPR119 agonist) and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis (NASH), obesity and ty...
Product Name : DA-1241
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 11, 2022
Lead Product(s) : DA-1241
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : NeuroBo Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : STP0404
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ST Pharm Presents Phase 1 Clinical Trial Results of HIV Treatment Candidate at AIDS 2022
Details : STP0404 also demonstrated consistent pharmacokinetics at various dose levels showing drug exposure increased less-proportionally with dose, and presented an elimination half-life can support once daily dosing regimen.
Product Name : STP0404
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 08, 2022
Lead Product(s) : STP0404
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable