Samsung Bioepis announced that its first drug candidate has been designated as a Fast Track product by the U.S. Food and Drug Administration (FDA).
The company revealed on October 21 that its cancer treatment candidate, SBE303, has received Fast Track designation from the FDA.
The Fast Track program is designed to expedite the development and review of drugs that demonstrate potential for treating serious conditions where existing therapies are limited. One of the main advantages of this designation is the ability to consult with the FDA throughout the development process, which helps reduce clinical design and approval risks from the early stages.
SBE303 is an antibody-drug conjugate (ADC) that targets cancer cells by attaching drugs to antibodies. Its target is a protein called Nexitin-4, which plays a role in cell adhesion and is produced in significantly higher amounts in certain cancer cells, such as those found in bladder cancer. This allows the cancer drug to accurately locate and attack cancer cells.
The designation specifically targets patients with locally advanced or metastatic urothelial carcinoma who have previously received Nexitin-4 targeted therapy. It aims to address the needs of patients who have limited options after existing treatments.
Jung Byung-in, head of the Regulatory Affairs team at Samsung Bioepis, stated, "The FDA's Fast Track designation for SBE303 recognizes its potential to address unmet medical needs in treating serious diseases. This also demonstrates that Samsung Bioepis possesses global-level research and development capabilities in new drug development."
In addition, Samsung Bioepis announced that it signed a local partnership agreement with the Brazilian Ministry of Health to supply its Soliris biosimilar, SB12 (ingredient name: eculizumab).
As a result, the company will exclusively supply rare disease treatments in Brazil, the largest pharmaceutical market in Latin America, for the next ten years. This expands its local supply portfolio to include rare disease treatments, following its existing offerings in autoimmune and cancer therapies.
The company revealed on October 21 that its cancer treatment candidate, SBE303, has received Fast Track designation from the FDA.
The Fast Track program is designed to expedite the development and review of drugs that demonstrate potential for treating serious conditions where existing therapies are limited. One of the main advantages of this designation is the ability to consult with the FDA throughout the development process, which helps reduce clinical design and approval risks from the early stages.
SBE303 is an antibody-drug conjugate (ADC) that targets cancer cells by attaching drugs to antibodies. Its target is a protein called Nexitin-4, which plays a role in cell adhesion and is produced in significantly higher amounts in certain cancer cells, such as those found in bladder cancer. This allows the cancer drug to accurately locate and attack cancer cells.
The designation specifically targets patients with locally advanced or metastatic urothelial carcinoma who have previously received Nexitin-4 targeted therapy. It aims to address the needs of patients who have limited options after existing treatments.
Jung Byung-in, head of the Regulatory Affairs team at Samsung Bioepis, stated, "The FDA's Fast Track designation for SBE303 recognizes its potential to address unmet medical needs in treating serious diseases. This also demonstrates that Samsung Bioepis possesses global-level research and development capabilities in new drug development."
In addition, Samsung Bioepis announced that it signed a local partnership agreement with the Brazilian Ministry of Health to supply its Soliris biosimilar, SB12 (ingredient name: eculizumab).
As a result, the company will exclusively supply rare disease treatments in Brazil, the largest pharmaceutical market in Latin America, for the next ten years. This expands its local supply portfolio to include rare disease treatments, following its existing offerings in autoimmune and cancer therapies.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.