Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its pipeline drug candidate, FCN-338. This small-molecule Bcl-2 inhibitor will be evaluated for its efficacy in treating systemic light chain amyloidosis in combination with dexamethasone.
Previously, FCN-338 has garnered clinical trial approvals both in China and the United States for its development to address hematological malignancies and recurrent or refractory B-cell lymphoma. In the Chinese market, Abbvie’s Venclexta (venetoclax) stands as the only Bcl-2-targeted drug that has been approved. Additionally, Johnson & Johnson’s Darzalex Faspro (daratumumab, hyaluronidase) is commercially available for the treatment of light chain amyloidosis, positioning FCN-338 to potentially join a select group of targeted therapies for this condition.- Flcube.com
