CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors

China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors.

NBL-020: Anti-Tumor Necrosis Factor Type 2 Receptor Monoclonal Antibody
Supplied from CSPC’s US subsidiary NovaRock Biotherapeutics Ltd, NBL-020 is an anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody (mAb) based on its proprietary AFIS technology platform. TNFR2 belongs to the tumor necrosis factor receptor (TNFR) superfamily and serves to maintain immunosuppression within the tumor microenvironment. It does this through a variety of signaling pathways, directly or indirectly promoting tumor progression and stimulating immunosuppressive cell types, including regulatory T cells (Tregs) and bone marrow-derived suppressor cells (MDSCs).

Pre-Clinical Studies and US Approval
Pre-clinical studies have shown that NBL-020 has good safety, high affinity to target cells, and strong anti-tumor activity. In PD-1 sensitive and PD-1 resistant syngeneic animal models, NBL-020 as a monotherapy or combined with anti-PD-1 antibody can inhibit tumor growth and prolong a patient’s survival. The drug obtained clinical trial approval in the US in December 2022, paving the way for further global development.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry