Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational injectable drug, NCB003. This next-generation targeted coupling long-acting human interleukin-2 (IL-2) drug is being developed to treat patients with advanced malignant solid tumors who have failed standard treatments.
Preclinical Studies and Product Potential
Preclinical studies have demonstrated that NCB003, a Category 1 product, exhibits significant inhibitory effects on various in vivo transplanted tumors. The molecule has shown relative stability in blood circulation and possesses a longer half-life compared to traditional IL-2. Near the effective dose, NCB003 has proven to be safe and tolerable, offering a certain safety window, which is crucial for its potential as a therapeutic agent.
Competitive Landscape and Market Context
NCB003 is one of several similar products in development, including Nektar’s bempegaldesleukin, Sanofi’s SAR444245, Ascendis Pharma’s TransCon IL-2, Hengrui Medicine’s SHR-1916, and Mabwell’s 8MW2311. However, it is noteworthy that Nektar and Sanofi’s candidates have been suspended due to subpar efficacy, highlighting the competitive and challenging nature of the IL-2 drug development space.-Fineline Info & Tech
