China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the medullary system, in combination with azacytidine or chemotherapy.
FCN-338: A Small Molecule Bcl-2 Inhibitor for Hematological Malignancies
FCN-338, a small molecule Bcl-2 inhibitor, is under development to treat hematological malignancies and recurrent or refractory B-cell lymphoma. The drug has previously obtained clinical trial approvals in both China and the United States, highlighting its potential in addressing significant unmet medical needs.
Market Potential and Competition
The only Bcl-2-targeted drug approved in China is Abbvie’s Venclexta (venetoclax), which generated RMB 43.38 million (USD 6.3 million) in sales in 2022. This indicates a substantial market opportunity for FCN-338, especially if it can demonstrate efficacy and safety in its Phase II clinical trial. The approval and subsequent clinical development of FCN-338 position Shanghai Fosun Pharmaceutical as a contender in the competitive landscape of hematological cancer treatments.-Fineline Info & Tech
