Baili Pharmaceutical's EGFR/HER3 double antibody was approved for two clinical trials

Text|Pharmaceutical Mission Hills

The latest announcement by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China shows that the Class 1 new drug SI-B001 bispecific antibody injection declared by Bailey Pharmaceuticals has obtained two clinical trials implied licenses, and it is planned to be developed for: 1) Combine FOLFOX/FOLFIRI or irinotecan or fluorouracil in the treatment of unresectable or metastatic RAS wild-type BRAF wild-type MSS/pMMR colorectal cancer; 2) Combine osimertinib mesylate tablets in the treatment of third-generation patients with EGFR mutations Locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not sensitive to EGFR TKI or sensitive to third-generation EGFR TKI but resistant or progressed after treatment

Screenshot source: CDE official website

According to an earlier press release of Bailey Pharmaceuticals, SI-B001 is an EGFR/HER3 bispecific antibody that can simultaneously target EGFR and HER3 and inhibit EGFR/EGFR heterodimer and EGFR/HER3 homodimerization The body, and its downstream signaling pathways, inhibit tumor cell proliferation

Previously, SI-B001 has been approved to carry out a number of clinical studies in China, involving indications are: treatment of locally advanced or metastatic epithelial tumors, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer and so on

HER3 is a very important receptor in the EGFR family and has important functions in tumorigenesis, development, and drug resistance

Reference materials:

[1] Center for Drug Evaluation of China National Medical Products Administration.