Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA

Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but are not limited to, wild-type colorectal cancer, liver cancer, head and neck squamous cell carcinoma, pancreatic cancer, primary unknown adenocarcinoma, and squamous cell carcinoma.

MCLA-129 is a bispecific antibody (BsAb) that targets both the epidermal growth factor receptor (EGFR) and the stromal epithelial transforming factor (c-Met). This innovative therapy works by simultaneously blocking the signaling pathways of EGFR and c-Met, which are key drivers in tumor growth and survival. Additionally, MCLA-129 enhances the immune system’s ability to attack tumor cells through a process known as antibody-dependent cell-mediated cytotoxicity (ADCC). A similar product, US J&J’s Rybrevant (amivantamab), is already registered in the United States, highlighting the potential significance of MCLA-129 in the global oncology space. – Flcube.com

Fineline Info & Tech