China-based startup Burning Rock Biotech and German pharmaceutical firm Boehringer Ingelheim have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics. This agreement aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods, thereby promoting innovation and development in cancer treatment.

This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China.

Brigimadlin is a novel small-molecule drug developed by Boehringer Ingelheim as a MDM2-p53 antagonist. Recently, brigimadlin received approval from the China National Medical Products Administration (NMPA) for its Phase II clinical trial, known as Brightline-2, targeting locally advanced or metastatic MDM2-amplified, TP53 wild-type solid tumors. It offers new treatment options for patients with MDM2-amplified, TP53 wild-type cancers, such as Biliary Tract Carcinoma (BTC), and opens up a “pan-tumor” treatment approach targeting the MDM2-p53 axis.

Previous Phase I studies demonstrated anti-tumour activity for brigimadlin across various solid tumors, with particularly promising clinical efficacy observed in BTC patients.

With the formal approval of the Brightline-2 clinical trial, the safety and efficacy of brigimadlin will undergo further validation. Burning Rock will leverage its dual-center, internationally accredited laboratory, a global companion diagnostics registration pipeline, a comprehensive biomarker development solution for drug research, and its extensive experience in clinical projects and companion diagnostics development and submissions, providing comprehensive support for the research and development of the innovative drug brigimadlin and the development and validation of companion diagnostic assays, offering new hope for patients with hard-to-treat and rare cancers in China.