Innovent Secures Breakthrough Therapy Designation for IBI343 in Pancreatic Cancer Treatment
Thursday, January 16, 2025
Innovent Biologics has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for IBI343.
Pancreatic cancer is a highly aggressive disease, with a five-year survival rate of approximately 10%. Current treatment primarily involves systemic chemotherapy, but second-line options remain limited, with low response rates and poor outcomes.
CLDN18.2, a biomarker present in up to 70% of pancreatic cancers, offers a promising target for therapeutic intervention.
IBI343 is an innovative ADC designed to treat tumours expressing CLDN18.2. It has shown encouraging safety and efficacy in early-phase trials and is being evaluated in global studies for gastric and pancreatic cancers.
This anti-CLDN18.2 antibody-drug conjugate (ADC) is intended as a monotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) in patients who have progressed after at least one prior systemic therapy.
Innovent Biologics has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for IBI343.
Pancreatic cancer is a highly aggressive disease, with a five-year survival rate of approximately 10%. Current treatment primarily involves systemic chemotherapy, but second-line options remain limited, with low response rates and poor outcomes.
CLDN18.2, a biomarker present in up to 70% of pancreatic cancers, offers a promising target for therapeutic intervention.
IBI343 is an innovative ADC designed to treat tumours expressing CLDN18.2. It has shown encouraging safety and efficacy in early-phase trials and is being evaluated in global studies for gastric and pancreatic cancers.
This anti-CLDN18.2 antibody-drug conjugate (ADC) is intended as a monotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) in patients who have progressed after at least one prior systemic therapy.
In 2024, IBI343 also received NMPA BTD for treating advanced gastric/gastro-esophageal junction adenocarcinoma and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for advanced, unresectable, or metastatic PDAC.
The designation follows results from an ongoing Phase 1 clinical study conducted in China, Australia, and the United States (NCT05458219).
Source: innoventbio.com
