Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced the receipt of marketing approvals from the National Medical Products Administration (NMPA) for its FCN-159 and FCN-437c. These approvals mark significant milestones in the company’s pipeline, expanding its therapeutic reach across multiple indications.
FCN-159: A Selective MEK1/2 Inhibitor
FCN-159, a highly selective MEK1/2 inhibitor, has been approved for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, as well as pediatric and adolescent patients (aged 2 years and above) with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). This Category 1 chemical drug is also being developed for additional indications, including adult NF1, low-grade gliomas, extracranial arteriovenous malformations, and pediatric LCH.
FCN-437c: A Selective CDK4/6 Inhibitor
FCN-437c is an oral, highly selective CDK4/6 inhibitor approved for use in combination with fulvestrant for the treatment of HR-positive, HER2-negative recurrent or metastatic breast cancer in adult patients who have progressed after prior endocrine therapy. This Category 1 chemical drug is also awaiting regulatory decisions in China for the treatment of HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy for premenopausal, postmenopausal, and perimenopausal female patients.-Fineline Info & Tech
