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On December 2, the State Food and Drug Administration issued an announcement stating that it has recently passed the priority review and approval procedure to approve the import registration application of Stuximab (English name: Siltuximab for Injection) for the injection of rare disease drugs in urgent need of clinical use for human immunization.
The approval of Stuximab in China means that the drug has become the first and only drug approved for the treatment of HIV-negative and HHV-8-negative multicentric MCD in China, and it is also the first approved domestically.
MCD is a rare disease characterized by the growth of lymphoid tissue, which can produce abnormal proliferation of immune cells, and has many similarities with lymphoma in terms of symptoms and histological characteristics
Stuximab is a human-mouse chimeric monoclonal antibody that can block the binding of human interleukin-6 (IL-6) to the IL-6 receptor, inhibit IL-6, and then inhibit Cell growth
In January 2020, BeiGene and EUSA Pharma reached a partnership to obtain the exclusive development and commercialization rights of Stuximab in Greater China
In China, Stuximab was once included in the list of "First Batch of New Drugs Urgently Needed Overseas" due to rare disease drugs
