Changzhou Pharmaceutical Factory Ltd., a subsidiary of Shanghai Pharmaceutical Holdings, received the Drug Registration Certificate (Certificate No. 2021S01077, 2021S01078, 2021S01079) issued by the State Drug Administration for Lenalidomide Capsules (Specification 5mg, 10mg, 25mg), which was approved for production.
Drug name: Lenalidomide capsules
Dosage form: Capsule
Specification: 5mg, 10mg, 25mg
Registration classification: Chemical drug class 4
Batch number: State Drug Certificate H20213802, State Drug Certificate H20213803, State Drug Certificate H20213804
Approval conclusion: Meet the requirements of drug registration, approved for registration, issued a drug registration certificate.
Lenalidomide is a new generation of oral immunomodulatory drug with the function of inhibiting tumor cell proliferation, inducing tumor cell apoptosis and immunomodulation, mainly used in the treatment of multiple myeloma and myelodysplastic syndrome (MDS) and other conditions. It is used in combination with dexamethasone to treat adult patients with previously untreated multiple myeloma who are not candidates for transplantation. This product is used in combination with dexamethasone to treat adult patients with multiple myeloma who have received at least one prior therapy. This product is used in combination with rituximab to treat adult patients with follicular lymphoma (grades 1-3a) who have received prior therapy.
Lenalidomide capsules were first developed by Celgene Biopharmaceuticals and marketed in the U.S. in 2005. in December 2019, Changzhou Pharmaceutical Factory filed a registration and marketing application with the State Drug Administration for the drug, which was accepted.
Data from Minene.com shows that the national sales of Nalidomide capsules in 2020 will be approximately RMB 1.025 billion.
According to the relevant national policies, the varieties of generic drugs approved according to the new registration classification will receive greater support in areas such as medical insurance payment and medical institution procurement. Therefore, the approved production of Changzhou Pharmaceutical Factory's lenalidomide capsule is conducive to further expanding its market share in the field of hematology-tumor treatment and enhancing its market competitiveness, as well as accumulating valuable experience for the company's subsequent products to carry out generic drug development and registration filing.