AbClon announced on November 11 that it has received approval from China's National Medical Products Administration (NMPA) for a new Phase 2 clinical trial of AC101 (known as HLX22 under Henlius), a treatment being developed for various HER2-positive solid tumors.

AC101 is a pipeline that was licensed to Henlius, a subsidiary of Fosun Pharma. The clinical trial for AC101 will be conducted in combination with either trastuzumab and chemotherapy or trastuzumab deruxtecan (T-DXd). The goal is to develop it as a treatment for a variety of HER2-expressing solid tumors.

The HER2 protein targeted by AC101 plays a significant role in the development of several cancers, including breast cancer, gastric cancer, biliary tract cancer, pancreatic cancer, urothelial cancer, lung cancer, and ovarian cancer.

In a previous Phase 2 clinical trial for metastatic HER2-positive gastric cancer, AC101 demonstrated significant improvement in patient outcomes. The study showed that the survival rate and anticancer response were more than six times higher in patients treated with AC101, highlighting its potential effectiveness for a broad range of HER2-positive solid tumors.

AbClon has also received approval to conduct an international, multicenter Phase 3 clinical trial of HLX22 in combination with trastuzumab for HER2-positive gastric cancer. The trial is currently underway, with patient dosing ongoing in China, the United States, Japan, and Australia.

The company expects that the success of AC101 in treating HER2-positive gastric cancer will pave the way for its application in other HER2-positive solid tumors, further strengthening its position in the global oncology market.