Agree Realty(ADC) Prnewswire·2025-01-16 00:00Core Insights - Innovent Biologics has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) for IBI343, an anti-CLDN18.2 antibody-drug conjugate (ADC), aimed at treating advanced pancreatic ductal adenocarcinoma (PDAC) patients who have progressed after prior treatments [1][2][8] - The designation was based on promising results from an ongoing Phase 1 study, which showed favorable safety, tolerability, and antitumor activity of IBI343 in advanced PDAC patients [2][3] - IBI343 has also received Fast Track Designation from the U.S. FDA for treating advanced, unresectable or metastatic PDAC that has relapsed or is refractory to one prior line of therapy [2][8] Company Overview - Innovent Biologics is a biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various serious diseases, including oncology, cardiovascular, and autoimmune conditions [9] - The company has launched 13 products and has multiple assets in various stages of clinical trials, including 4 new drug applications under regulatory review [9] - Innovent collaborates with over 30 global healthcare companies, enhancing its research and development capabilities [9] Industry Context - Pancreatic cancer is characterized by a low 5-year survival rate of approximately 10%, with limited treatment options leading to poor patient outcomes [4] - Current therapies primarily involve systemic chemotherapy, with second-line treatment options yielding a chemotherapy response rate of only 6-16% and a median overall survival of about 6 to 9 months [4] - The presence of CLDN18.2 in 50% to 70% of pancreatic cancer cases makes it a significant target for therapeutic development, highlighting the need for innovative treatments like IBI343 [6][7]