MABPHARM-B(02181): The application for the marketing registration of CMAB807X class Sushu (Dusulimab Injection) has been approved.
MabPharmaceuticals-B (02181) announced that the recent New Drug Application (NDA) for its pipeline product CMAB807X monoclonal antibody injection has been approved by the National Medical Products Administration of the People's Republic of China. It is indicated for the treatment of (i) solid tumor bone metastasis patients or patients with multiple myeloma to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiotherapy or bone surgery) and (ii) the treatment of inoperable or potentially disastrous functional bone giant cell tumors, including adult and skeletally mature (defined as at least 1 mature long bone and body weight 45kg) adolescent patients.
Announcement of MABPHARM-B (02181): Recently, the company's pipeline product CMAB807X Class Xilu (denosumab injection) has obtained approval for its marketing registration application (NDA) from the China National Medical Products Administration. It is indicated for the treatment of (i) patients with solid tumor bone metastases or multiple myeloma to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiation therapy, or bone surgery), and (ii) treatment of giant cell tumors of bone that are inoperable or surgery may lead to severe functional impairments, including adult and skeletally mature (defined as at least 1 mature long bone with a body weight 45kg) adolescent patients.
CMAB807X Class Xilu (denosumab injection) is another specification of the fourth product CMAB807 Pubor (denosumab injection) approved for marketing by MabPharm. The company will work closely with partners to quickly promote CMAB807X Class Xilu (denosumab injection) into the China National Medical Insurance Program and expand its market channels, to rapidly achieve market coverage and sales growth. It is expected that this product will provide significant support for the company's drug sales and profit growth. The company has also initiated overseas marketing promotion and registration activities for CMAB807X Class Xilu (denosumab injection) and expects it to achieve impressive sales performance in overseas markets as well.
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