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Article source: Medical Cube Info
Author: Pickup
On January 11, the CDE official website showed that the innovative CD20 monoclonal antibody zebetuzumab (R&D code: HS006, trade name: Enricix) independently developed by Borui Bio/Hisun Bio was used for initial treatment of CD20 positive The marketing application for the indication of diffuse large B-cell lymphoma (DLBCL) was accepted by the State Food and Drug Administration
.
This is the first category 1 innovative biological drug marketing application accepted by the NMPA for Bory.
DLBCL is a type of malignant tumor with relatively large heterogeneity originating from B lymphocytes, showing diffuse growth.
The nucleus of tumor cells is similar in size to that of normal tissue cells or larger than that of tissue cells, usually larger than that of normal lymphocytes.
2 times
.
DLBCL is the most common adult non-Hodgkin lymphoma (NHL) worldwide, accounting for 30% to 40% of all geographic NHLs
Zebetuzumab (HS006) is a human-mouse chimeric monoclonal antibody, which can specifically bind to the CD20 antigen on the surface of B cells, and through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement Dependent cytotoxicity (CDC) and other clearance of B cells
.
Compared to Rituxan (rituximab), zebetuzumab has a different amino acid sequence and a different binding epitope
.
Shows stronger ADCC activity in in vitro biological activity studies; shows larger steady-state volume of distribution and lower serum drug exposure levels in human pharmacokinetic studies; More durable clearance of B cells and more durable activation of CD3+/CD8+ T cells
In a phase III confirmatory clinical study, zebetuzumab injection combined with CHOP was non-inferior to R-CHOP in ORR in newly treated patients with diffuse large B-cell lymphoma, and the CR rate was significantly higher at the end of treatment; In terms of long-term survival benefit, the 1-year PFS and OS of the zebetumab injection group showed a trend of being significantly better than that of the rituximab group.
The CR rate of the monoclonal antibody injection group was significantly higher, and the 1-year PFS and OS were also significantly better than those of the Rituxan group
.
Currently, more than 10 innovative products of Borui Bio are in the clinical research stage, involving targets including PD-L1 / TGF-β (BR102), CD73 (BR101), Her2 (HS022/HS627), SIRPα (BR105), etc.
; the technology involved Including monoclonal antibody, double antibody, tertiary antibody, ADC, fusion protein
.
Among them, BR110 is the world's first anti-CD3/CD19/CD20 tertiary antibody product to enter the clinic
The CD20 mAb innovative drugs currently listed in China include Roche's rituximab and ortuzumab and Novartis' ofatumumab
PharmaGo
In terms of biosimilars, the rituximab biosimilars of Innovent and Henlius have been approved for marketing in China, and the rituximab biosimilars of Shenzhou Cell are currently in the "approval for listing" stage
