Baiji Shenzhou Ruifumei was approved for the third adaptive treatment of relapsed/re treatable inert lymphoma

On November 19th, according to a notice issued by the NMPA Drug Approval, the new drug approval number was obtained for the lynadamine (Rui Fumei) in Baiji Shenzhou.
The drug is intended to be used in the same way as lyxi monoantigen, the treatment of patients with recurring or refractic inert lymphoma (filamentatic or marginal lymphoma) (JXHS1900151 / JXHS1900152 / JXHS1900153) has been included in the drug review center (CDE) priority review, on the grounds that there are clear therapeutic advantages.
the approval number associated with the acceptance number and early last year included in the priority review acceptance number consistent, meaning that the use of amine for the treatment of recurrence or recurring inert lymphoma was officially approved in China!This new adaptation application for lysamine is based on the results of a key Phase 3 clinical trial, AUGMENT.
AUGMENT is a randomized, double-blind, multi-center clinical trial in which 358 patients with recurring or refragtic folytic folytic lymphoma and marginal lymphoma were admitted to the trial.
results showed that the combination of refum and lyxi monoantigen significantly improved patients' progression-free survival (PFS) at a medium follow-up time of 28.3 months, reduced the risk of disease progression or death by 54% compared to the control group, and increased the risk of disease in patients by more than two years (39.4 months VS 14.1 months).
addition, the overall remission rate (78% VS 53%) and the duration of continuous remission (37 months VS 22 months) were significantly higher in patients in the lysamine and lysoxi monoantigen groups than in the control group.
-filtered lymphoma (FL) and marginal lymphoma (MZL) are two major inert lymphomas, of which FL is the most common subsethic, accounting for about 20%-25% of all non-Hodgkin's lymphoma (NHL) incidence, followed by MZL, which accounts for 5% to 17% of all NHL incidence.
2018 World Cancer Morbidity and Death Report (Globocan 2018) estimates that there are 88,090 NHL cases in China.
FL and MZL cannot be cured in the event of previous treatment, and existing treatment options are very limited in their effectiveness and safety, coupled with the fact that patients are often older and have complications, there is a high degree of unsecured medical needs in this area."
is an oral immunomodulation drug developed by Celgene, a subsidiary of BMS, which is primarily used to treat blood cancers such as multiple myeloma, myeloid growth syndrome and lymphoma.
July 2017, Baiji Shenzhou acquired the exclusive distribution rights of the drug in China through a strategic partnership with Xinji.
first approved for listing in China in 2013, Ruifumei has approved two adaptations for adult multiple myeloma patients in China.